This presentation discusses AGTC's visionary gene therapy programs to treat ophthalmic diseases. It highlights AGTC's lead product candidates for X-linked Retinoschisis (XLRS), Achromatopsia (ACHM-B3 and A3), and X-linked Retinitis Pigmentosa (XLRP). It also summarizes AGTC's competitive advantages in gene therapy manufacturing and its key upcoming milestones, including filing INDs for ACHM-A3 and XLRP and reporting initial clinical data for XLRS and ACHM-B3 programs in 2016. AGTC aims to become the world leader in ophthalmology gene therapy through its broad pipeline and partnerships.
The document summarizes the development of an anti-VEGF eye drop called PAN-90806 being developed by PanOptica for the treatment of wet age-related macular degeneration and other retinal diseases. It describes positive preliminary results from a Phase 1/2 clinical trial in wet AMD patients showing biological activity with no systemic side effects. It also outlines plans to further study PAN-90806 using an advanced formulation in additional clinical trials for wet AMD and proliferative diabetic retinopathy. Developing an effective anti-VEGF eye drop could provide significant benefits over frequent eye injections.
This document discusses a clinical trial being conducted by Ocata Therapeutics to evaluate the safety and efficacy of retinal pigment epithelium (RPE) cell transplantation for dry age-related macular degeneration (AMD). Previous phase 1 trials showed anatomical engraftment and functional improvement in vision. The current phase 2 trial will evaluate three regimens of short-term immunosuppression to prevent rejection of the transplanted cells. Safety will be the primary outcome measured with the goal of establishing a protocol to maintain graft survival without long-term immunosuppression.
Luminate is a drug being developed by Allegro Ophthalmics to treat retinal diseases. It works through a novel anti-integrin mechanism of action compared to existing anti-VEGF drugs. Phase 2 studies showed Luminate had a 65% efficacy rate in resolving vitreomacular traction, a robust safety profile, and durability of at least 3 months in treating diabetic macular edema and wet age-related macular degeneration. Ongoing phase 2b studies are further evaluating Luminate's potential to treat diabetic macular edema, proliferative vitreoretinopathy, and as an alternative to anti-VEGF drugs with longer duration of effect.
The document discusses a small aperture intraocular lens (IOL) called the IC-8 IOL. It summarizes results from a post-market study showing the IC-8 IOL provides excellent visual acuity at far, intermediate, and near distances. Specifically, it found mean binocular uncorrected visual acuities of 20/20 or better for far and intermediate distances and 20/32 for near distances. The IC-8 IOL also demonstrated increased tolerance to uncorrected astigmatism compared to monofocal IOLs and maintained contrast sensitivity similar to monofocal IOLs. Additionally, the IC-8 IOL requires no special surgical technique for implantation and allows for ocular imaging and retinal procedures
Icon Bioscience is developing improved ophthalmic drugs using its proprietary Verisome® technology to enable controlled, extended drug release with a single injection. Its lead product, IBI-10090, is a Verisome® formulation of dexamethasone for post-cataract surgery inflammation that has completed successful Phase 2 and 3 trials. Icon has a pipeline of additional ophthalmic products in development and expects to file an NDA for IBI-10090 in late 2015/early 2016, with potential to generate over $500 million in annual sales in the US alone. Icon aims to address large, unsatisfied ophthalmic markets through more convenient drug delivery with its Verisome® platform.
1. RPS Diagnostics develops novel point-of-care technology platforms, reagents, and therapeutic agents for eye care and infectious disease testing.
2. Their proprietary platforms include InflammaDry for dry eye detection and FebriDx for respiratory fever testing. They have 3 additional POC tests in clinical trials and a robust pipeline of products.
3. Their products help physicians provide better patient management by reducing misdiagnosis, unnecessary treatment, and disease spread through rapid, easy-to-use testing. This improves patient outcomes and lowers costs.
The document summarizes updates on corneal cross-linking (CXL) technology from Avedro, including:
1) In March 2015, Avedro received a letter from the FDA requesting further information about equivalency between study devices and commercial systems for CXL to treat keratoconus and ectasia.
2) Agreement was reached on additional measurements required to address the FDA's questions. The application was resubmitted in October 2015.
3) Preliminary data is presented on trials of a new CXL technique called PiXL for treating myopia, keratoconus, and post-cataract refractive error, showing safety and efficacy.
This presentation discusses AGTC's visionary gene therapy programs to treat ophthalmic diseases. It highlights AGTC's lead product candidates for X-linked Retinoschisis (XLRS), Achromatopsia (ACHM-B3 and A3), and X-linked Retinitis Pigmentosa (XLRP). It also summarizes AGTC's competitive advantages in gene therapy manufacturing and its key upcoming milestones, including filing INDs for ACHM-A3 and XLRP and reporting initial clinical data for XLRS and ACHM-B3 programs in 2016. AGTC aims to become the world leader in ophthalmology gene therapy through its broad pipeline and partnerships.
The document summarizes the development of an anti-VEGF eye drop called PAN-90806 being developed by PanOptica for the treatment of wet age-related macular degeneration and other retinal diseases. It describes positive preliminary results from a Phase 1/2 clinical trial in wet AMD patients showing biological activity with no systemic side effects. It also outlines plans to further study PAN-90806 using an advanced formulation in additional clinical trials for wet AMD and proliferative diabetic retinopathy. Developing an effective anti-VEGF eye drop could provide significant benefits over frequent eye injections.
This document discusses a clinical trial being conducted by Ocata Therapeutics to evaluate the safety and efficacy of retinal pigment epithelium (RPE) cell transplantation for dry age-related macular degeneration (AMD). Previous phase 1 trials showed anatomical engraftment and functional improvement in vision. The current phase 2 trial will evaluate three regimens of short-term immunosuppression to prevent rejection of the transplanted cells. Safety will be the primary outcome measured with the goal of establishing a protocol to maintain graft survival without long-term immunosuppression.
Luminate is a drug being developed by Allegro Ophthalmics to treat retinal diseases. It works through a novel anti-integrin mechanism of action compared to existing anti-VEGF drugs. Phase 2 studies showed Luminate had a 65% efficacy rate in resolving vitreomacular traction, a robust safety profile, and durability of at least 3 months in treating diabetic macular edema and wet age-related macular degeneration. Ongoing phase 2b studies are further evaluating Luminate's potential to treat diabetic macular edema, proliferative vitreoretinopathy, and as an alternative to anti-VEGF drugs with longer duration of effect.
The document discusses a small aperture intraocular lens (IOL) called the IC-8 IOL. It summarizes results from a post-market study showing the IC-8 IOL provides excellent visual acuity at far, intermediate, and near distances. Specifically, it found mean binocular uncorrected visual acuities of 20/20 or better for far and intermediate distances and 20/32 for near distances. The IC-8 IOL also demonstrated increased tolerance to uncorrected astigmatism compared to monofocal IOLs and maintained contrast sensitivity similar to monofocal IOLs. Additionally, the IC-8 IOL requires no special surgical technique for implantation and allows for ocular imaging and retinal procedures
Icon Bioscience is developing improved ophthalmic drugs using its proprietary Verisome® technology to enable controlled, extended drug release with a single injection. Its lead product, IBI-10090, is a Verisome® formulation of dexamethasone for post-cataract surgery inflammation that has completed successful Phase 2 and 3 trials. Icon has a pipeline of additional ophthalmic products in development and expects to file an NDA for IBI-10090 in late 2015/early 2016, with potential to generate over $500 million in annual sales in the US alone. Icon aims to address large, unsatisfied ophthalmic markets through more convenient drug delivery with its Verisome® platform.
1. RPS Diagnostics develops novel point-of-care technology platforms, reagents, and therapeutic agents for eye care and infectious disease testing.
2. Their proprietary platforms include InflammaDry for dry eye detection and FebriDx for respiratory fever testing. They have 3 additional POC tests in clinical trials and a robust pipeline of products.
3. Their products help physicians provide better patient management by reducing misdiagnosis, unnecessary treatment, and disease spread through rapid, easy-to-use testing. This improves patient outcomes and lowers costs.
The document summarizes updates on corneal cross-linking (CXL) technology from Avedro, including:
1) In March 2015, Avedro received a letter from the FDA requesting further information about equivalency between study devices and commercial systems for CXL to treat keratoconus and ectasia.
2) Agreement was reached on additional measurements required to address the FDA's questions. The application was resubmitted in October 2015.
3) Preliminary data is presented on trials of a new CXL technique called PiXL for treating myopia, keratoconus, and post-cataract refractive error, showing safety and efficacy.
Posterior Segment Company Showcase - Graybug VisionHealthegy
Posterior Segment Company Showcase - Graybug Vision at OIS@AAO 2016.
Presenter:
Jeffrey Cleland, PhD, President & CEO
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The document describes Zepto, an innovative disposable device for cataract surgery that uses precision-pulse technology to create an accurate and reproducible capsulotomy quickly and safely. It discusses studies showing Zepto results in minimal temperature change in the eye and stronger capsulotomy edges compared to other methods. The document also outlines Dymedex's market analysis projecting rapid adoption of Zepto as it addresses the needs of high-risk patient populations and its ease of use could make it the standard of care.
The document discusses the IRIS Registry, the nation's first comprehensive eye disease clinical database created by the American Academy of Ophthalmology. The IRIS Registry collects data directly from electronic health records to improve care delivery, meet federal reporting requirements, advance medical research, and provide physicians with analytics on their performance. It has integrated with 39 EHR systems and collected data on over 60 million patient visits. The registry contains valuable clinical data that can be used for research studies, clinical trials, and monitoring treatment outcomes and patterns of care.
Vision Medicines is developing two drug candidates, VM100 and VM200, to treat retinal diseases with high unmet medical need and large market opportunities. VM100 is in Phase 2/3 development for geographic atrophy and intermediate AMD, with a combined $20B market. VM200 is in preclinical development for Stargardt disease, an orphan indication with no approved therapies and a $6B market opportunity. Both drugs address the underlying disease mechanisms and have demonstrated preclinical efficacy in preserving retinal structure and function. Vision Medicines aims to develop these assets and consolidate the fragmented ophthalmology space, which has fewer products per company than other therapeutic areas.
The document summarizes research on the IC-8TM small-aperture intraocular lens. Optical modeling shows it extends the depth of focus compared to monofocal and bifocal lenses. Clinical data from patients found it provided a broad range of clear vision from near to far, with minimal visual symptoms. The IC-8TM lens can be implanted using standard cataract surgery techniques and allows for posterior segment assessments and procedures.
Presentation from OIS@ASCRS 2016
James Brandt, MD, Principal Investigator
Video Presentation:
https://www.youtube.com/watch?v=jvIozhPMSQ8&list=PL1dmdBNnPTZJBhQxPOp0vdNg3s3wtN2yw&index=30
The document summarizes Avedro's progress in corneal cross-linking. It discusses Avedro signing agreements to acquire exclusive rights to the world's leading riboflavin supplier and UV-A device supplier, allowing it to offer a complete line of cross-linking procedures. It also presents data on Avedro's PiXL refractive cross-linking system showing its potential to treat myopia and astigmatism non-invasively. Upcoming clinical trials and FDA submissions for various Avedro technologies are mentioned as well.
Posterior Segment Company Showcase - AGTCHealthegy
Posterior Segment Company Showcase - AGTC at OIS@AAO 2016.
Presenter:
Sue Washer, President & CEO
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Presentation from OIS@ASCRS 2016
Rajesh K. Rajpal, MD, Chief Medical Officer
Video Presentation:
https://www.youtube.com/watch?v=Wbq-D5kwMUk&list=PL1dmdBNnPTZJBhQxPOp0vdNg3s3wtN2yw&index=39
This document discusses Avedro's corneal cross-linking technology for treating keratoconus and ectasia. It summarizes that in February 2015 an FDA advisory committee voted to approve Avedro's application, but in March 2015 the FDA requested additional information. It then provides several case studies demonstrating the effectiveness of Avedro's Photorefractive Intrastromal Cross-Linking (PiXL) technique for keratoconus, post-LASIK ectasia, post-cataract myopia, and refractive enhancement post PRK or for hyperopia correction.
Anterior Segment Company Showcase - AvedroHealthegy
Anterior Segment Company Showcase - Avedro at OIS@AAO 2016.
Presenter:
Rajesh K. Rajpal, MD, Chief Medical Officer
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EyeGate Pharmaceuticals is developing two drug delivery platforms - a crosslinked hyaluronic acid eye drop called Ocular Bandage Gel to promote wound healing after corneal surgery or injuries, and an iontophoresis delivery system to administer the corticosteroid dexamethasone phosphate (EGP-437) after cataract surgery or for anterior uveitis. Positive pilot clinical trial data was announced for Ocular Bandage Gel in accelerating wound healing after photorefractive keratectomy. Later stage clinical trials are underway or planned for EGP-437 to reduce inflammation for cataract surgery and uveitis, with FDA filings targeted for 2018. EyeGate licensed worldwide commercial rights for EGP-
OPT-302 is a soluble form of VEGFR-3 that inhibits VEGF-C and VEGF-D, blocking their binding to VEGFR-2 and VEGFR-3. It is being developed in combination with anti-VEGF-A therapies for the treatment of wet AMD. A Phase 1/2A clinical trial is actively recruiting wet AMD patients to evaluate the safety, pharmacokinetics, and efficacy of multiple doses of intravitreal OPT-302 in combination with ranibizumab. Preliminary data is expected in early 2016, with the goal of demonstrating OPT-302 can improve outcomes when added to anti-VEGF-A therapy by more completely suppressing the VEGF pathway.
Posterior Segment Company Showcase - Ohr pharmaceuticalHealthegy
Posterior Segment Company Showcase - Ohr pharmaceutical at OIS@AAO 2016.
Presenter:
Jason Slakter, CEO
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Posterior Segment Company Showcase - Alimera SciencesHealthegy
Posterior Segment Company Showcase - Alimera Sciences at OIS@AAO 2016.
Presenter:
Dan Myers, CEO
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Ocular Therapeutix is developing sustained-release drug therapies for ophthalmic conditions to improve patient outcomes and compliance. Their lead product, DEXTENZA, is an intracanalicular insert delivering dexamethasone for up to 30 days after cataract surgery to reduce pain and inflammation. Phase 3 trials showed DEXTENZA was well-tolerated and effective in meeting primary efficacy endpoints. If approved, DEXTENZA could become the new standard of care by replacing complex topical drop regimens. The company is also developing sustained-release therapies for glaucoma and posterior segment diseases in collaboration with Regeneron.
Presentation from OIS@ASCRS 2016
Tom Mitro, President & COO
Video Presentation:
https://www.youtube.com/watch?v=rjLnP6lmRWU&list=PL1dmdBNnPTZJBhQxPOp0vdNg3s3wtN2yw&index=29
Presentation from OIS@ASCRS 2016
Amar Sawhney, PhD, President, CEO & Chairman
Video Presentation:
https://www.youtube.com/watch?v=nGQzo6czij0&list=PL1dmdBNnPTZJBhQxPOp0vdNg3s3wtN2yw&index=31
Ivantis is developing the Hydrus Microstent, a minimally invasive implant designed to dilate and scaffold the natural outflow path of the eye to treat glaucoma. It has raised $107 million and conducted clinical trials involving over 2,000 patients in 21 countries. A recent randomized controlled trial found that 74% of patients who received the Hydrus Microstent in addition to cataract surgery experienced at least a 20% reduction in eye pressure without medication, compared to 46% for cataract surgery alone, demonstrating the Hydrus' increasing treatment effect over time. Ivantis is pursuing US FDA approval for the Hydrus Microstent based on these promising clinical results.
DigiSight is a vertically integrated mobile data management system for ophthalmology. It announced a new product suite and is collaborating with organizations on global initiatives. DigiSight provides a platform to leverage growing mobile technologies and data to improve patient care, research, and healthcare efficiencies through remote monitoring and mobile tools. It is used by practices and institutions across the US and working with the Himalayan Cataract Project internationally.
This document provides an overview of recent equity market performance and trends, including:
- Major US indices were largely flat in Q3 but pulled back from peaks in September due to geopolitical tensions.
- Healthcare and utilities sectors outperformed while energy and industrials underperformed year-to-date.
- Biotech and medtech sectors have significantly outperformed the S&P 500 over the past 10 and 5 years.
- Ophthalmology has been an attractive area for M&A and biotech IPOs in recent years.
Posterior Segment Company Showcase - Graybug VisionHealthegy
Posterior Segment Company Showcase - Graybug Vision at OIS@AAO 2016.
Presenter:
Jeffrey Cleland, PhD, President & CEO
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For more ophthalmology innovation
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The document describes Zepto, an innovative disposable device for cataract surgery that uses precision-pulse technology to create an accurate and reproducible capsulotomy quickly and safely. It discusses studies showing Zepto results in minimal temperature change in the eye and stronger capsulotomy edges compared to other methods. The document also outlines Dymedex's market analysis projecting rapid adoption of Zepto as it addresses the needs of high-risk patient populations and its ease of use could make it the standard of care.
The document discusses the IRIS Registry, the nation's first comprehensive eye disease clinical database created by the American Academy of Ophthalmology. The IRIS Registry collects data directly from electronic health records to improve care delivery, meet federal reporting requirements, advance medical research, and provide physicians with analytics on their performance. It has integrated with 39 EHR systems and collected data on over 60 million patient visits. The registry contains valuable clinical data that can be used for research studies, clinical trials, and monitoring treatment outcomes and patterns of care.
Vision Medicines is developing two drug candidates, VM100 and VM200, to treat retinal diseases with high unmet medical need and large market opportunities. VM100 is in Phase 2/3 development for geographic atrophy and intermediate AMD, with a combined $20B market. VM200 is in preclinical development for Stargardt disease, an orphan indication with no approved therapies and a $6B market opportunity. Both drugs address the underlying disease mechanisms and have demonstrated preclinical efficacy in preserving retinal structure and function. Vision Medicines aims to develop these assets and consolidate the fragmented ophthalmology space, which has fewer products per company than other therapeutic areas.
The document summarizes research on the IC-8TM small-aperture intraocular lens. Optical modeling shows it extends the depth of focus compared to monofocal and bifocal lenses. Clinical data from patients found it provided a broad range of clear vision from near to far, with minimal visual symptoms. The IC-8TM lens can be implanted using standard cataract surgery techniques and allows for posterior segment assessments and procedures.
Presentation from OIS@ASCRS 2016
James Brandt, MD, Principal Investigator
Video Presentation:
https://www.youtube.com/watch?v=jvIozhPMSQ8&list=PL1dmdBNnPTZJBhQxPOp0vdNg3s3wtN2yw&index=30
The document summarizes Avedro's progress in corneal cross-linking. It discusses Avedro signing agreements to acquire exclusive rights to the world's leading riboflavin supplier and UV-A device supplier, allowing it to offer a complete line of cross-linking procedures. It also presents data on Avedro's PiXL refractive cross-linking system showing its potential to treat myopia and astigmatism non-invasively. Upcoming clinical trials and FDA submissions for various Avedro technologies are mentioned as well.
Posterior Segment Company Showcase - AGTCHealthegy
Posterior Segment Company Showcase - AGTC at OIS@AAO 2016.
Presenter:
Sue Washer, President & CEO
Powered by:
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For more ophthalmology innovation
Visit us at www.ois.net
Presentation from OIS@ASCRS 2016
Rajesh K. Rajpal, MD, Chief Medical Officer
Video Presentation:
https://www.youtube.com/watch?v=Wbq-D5kwMUk&list=PL1dmdBNnPTZJBhQxPOp0vdNg3s3wtN2yw&index=39
This document discusses Avedro's corneal cross-linking technology for treating keratoconus and ectasia. It summarizes that in February 2015 an FDA advisory committee voted to approve Avedro's application, but in March 2015 the FDA requested additional information. It then provides several case studies demonstrating the effectiveness of Avedro's Photorefractive Intrastromal Cross-Linking (PiXL) technique for keratoconus, post-LASIK ectasia, post-cataract myopia, and refractive enhancement post PRK or for hyperopia correction.
Anterior Segment Company Showcase - AvedroHealthegy
Anterior Segment Company Showcase - Avedro at OIS@AAO 2016.
Presenter:
Rajesh K. Rajpal, MD, Chief Medical Officer
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For more ophthalmology innovation
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EyeGate Pharmaceuticals is developing two drug delivery platforms - a crosslinked hyaluronic acid eye drop called Ocular Bandage Gel to promote wound healing after corneal surgery or injuries, and an iontophoresis delivery system to administer the corticosteroid dexamethasone phosphate (EGP-437) after cataract surgery or for anterior uveitis. Positive pilot clinical trial data was announced for Ocular Bandage Gel in accelerating wound healing after photorefractive keratectomy. Later stage clinical trials are underway or planned for EGP-437 to reduce inflammation for cataract surgery and uveitis, with FDA filings targeted for 2018. EyeGate licensed worldwide commercial rights for EGP-
OPT-302 is a soluble form of VEGFR-3 that inhibits VEGF-C and VEGF-D, blocking their binding to VEGFR-2 and VEGFR-3. It is being developed in combination with anti-VEGF-A therapies for the treatment of wet AMD. A Phase 1/2A clinical trial is actively recruiting wet AMD patients to evaluate the safety, pharmacokinetics, and efficacy of multiple doses of intravitreal OPT-302 in combination with ranibizumab. Preliminary data is expected in early 2016, with the goal of demonstrating OPT-302 can improve outcomes when added to anti-VEGF-A therapy by more completely suppressing the VEGF pathway.
Posterior Segment Company Showcase - Ohr pharmaceuticalHealthegy
Posterior Segment Company Showcase - Ohr pharmaceutical at OIS@AAO 2016.
Presenter:
Jason Slakter, CEO
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Posterior Segment Company Showcase - Alimera SciencesHealthegy
Posterior Segment Company Showcase - Alimera Sciences at OIS@AAO 2016.
Presenter:
Dan Myers, CEO
Powered by:
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For more ophthalmology innovation
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Ocular Therapeutix is developing sustained-release drug therapies for ophthalmic conditions to improve patient outcomes and compliance. Their lead product, DEXTENZA, is an intracanalicular insert delivering dexamethasone for up to 30 days after cataract surgery to reduce pain and inflammation. Phase 3 trials showed DEXTENZA was well-tolerated and effective in meeting primary efficacy endpoints. If approved, DEXTENZA could become the new standard of care by replacing complex topical drop regimens. The company is also developing sustained-release therapies for glaucoma and posterior segment diseases in collaboration with Regeneron.
Presentation from OIS@ASCRS 2016
Tom Mitro, President & COO
Video Presentation:
https://www.youtube.com/watch?v=rjLnP6lmRWU&list=PL1dmdBNnPTZJBhQxPOp0vdNg3s3wtN2yw&index=29
Presentation from OIS@ASCRS 2016
Amar Sawhney, PhD, President, CEO & Chairman
Video Presentation:
https://www.youtube.com/watch?v=nGQzo6czij0&list=PL1dmdBNnPTZJBhQxPOp0vdNg3s3wtN2yw&index=31
Ivantis is developing the Hydrus Microstent, a minimally invasive implant designed to dilate and scaffold the natural outflow path of the eye to treat glaucoma. It has raised $107 million and conducted clinical trials involving over 2,000 patients in 21 countries. A recent randomized controlled trial found that 74% of patients who received the Hydrus Microstent in addition to cataract surgery experienced at least a 20% reduction in eye pressure without medication, compared to 46% for cataract surgery alone, demonstrating the Hydrus' increasing treatment effect over time. Ivantis is pursuing US FDA approval for the Hydrus Microstent based on these promising clinical results.
DigiSight is a vertically integrated mobile data management system for ophthalmology. It announced a new product suite and is collaborating with organizations on global initiatives. DigiSight provides a platform to leverage growing mobile technologies and data to improve patient care, research, and healthcare efficiencies through remote monitoring and mobile tools. It is used by practices and institutions across the US and working with the Himalayan Cataract Project internationally.
This document provides an overview of recent equity market performance and trends, including:
- Major US indices were largely flat in Q3 but pulled back from peaks in September due to geopolitical tensions.
- Healthcare and utilities sectors outperformed while energy and industrials underperformed year-to-date.
- Biotech and medtech sectors have significantly outperformed the S&P 500 over the past 10 and 5 years.
- Ophthalmology has been an attractive area for M&A and biotech IPOs in recent years.
Presentation from OIS@ASCRS 2016
Joseph Boorady, President & CEO
Video Presentaion:
https://www.youtube.com/watch?v=I_rVlB71VX4&index=32&list=PL1dmdBNnPTZJBhQxPOp0vdNg3s3wtN2yw
This document provides an industry update on venture healthcare from Silicon Valley Bank. It includes statistics on healthcare investment as a percentage of total venture investment from 2000-2013. It shows that biopharma has remained around 15-19% while devices have declined from 10% to 7%. The document also discusses trends in healthcare funding and exits, with biopharma acquisitions and IPOs increasing in recent years compared to devices. It analyzes top investors and deals in biopharma and devices from 2012-2013, finding greater corporate involvement in biopharma but less in devices.
SPOTLIGHT ON THE PREMIUM CHANNEL – Bausch + LombHealthegy
Presentation from OIS@ASCRS 2016
Andrew Chang, General Manager & VP, US Surgical
Video Presentation:
https://www.youtube.com/watch?v=xxXQ5IKIMn8&list=PL1dmdBNnPTZJBhQxPOp0vdNg3s3wtN2yw&index=36
Breakout Session: Cybersecurity in Medical DevicesHealthegy
Presentation by PwC at Medtech Conference 2016.
Participant:
Geoff Fisher, Director – PwC
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The document discusses InnFocus, a surgical alternative for glaucoma. It is currently in its final FDA phase of trials and has CE Mark approval in Europe. Clinical trials show it is a safe and effective procedure that lowers intraocular pressure to below 14 mmHg in over 80% of patients. It provides over a 50% reduction in pressure from baseline and allows over 70% of patients to discontinue glaucoma medications after 3 years. The outcomes meet the standards for preventing vision loss progression according to the AGIS study. InnFocus represents a promising new treatment option for the large and growing glaucoma market.
This document provides a summary of key events and developments in ophthalmology in 2015. It discusses growth in attendance at major ophthalmology conferences, FDA drug and device approvals, positive results from phase 3 trials of gene therapy for RPE65-mediated retinal dystrophy and Humira for uveitis. It also reviews trends in the use of anti-VEGF drugs to treat wet AMD, global rates of IVT injections, the ophthalmic drug market, and causes of blindness worldwide. Tables and graphs are included to illustrate drugs, procedures, technologies, and market data.
GrayBug is developing an injectable, long-acting ocular drug delivery technology called GB-102 for treating wet age-related macular degeneration. GB-102 is a dual anti-VEGF/anti-PDGF therapeutic that enables injections every 4-6 months, compared to monthly injections currently required. GrayBug has worldwide rights to the technology from Johns Hopkins University and aims to file an IND for GB-102 in wet AMD in 2016. The company is also exploring applications of its technology for glaucoma and other ocular diseases, with the goal of developing long-acting drugs that improve compliance over daily eye drops.
Gobiquity creates mobile diagnostic solutions to enable early detection and prevention of vision impairment through broad access. Their flagship product, GoCheck Kids, is a clinically validated mobile photoscreener that identifies Amblyopia Risk Factors. It has experienced rapid adoption, screening over 39,000 children across 25 states. Gobiquity plans to evolve the platform into a comprehensive digital diagnostics suite to address additional large vision markets like age-related macular degeneration and diabetic retinopathy that affect millions. Their uniquely positioned solutions leverage a hybrid team's expertise in mobile imaging, ophthalmology, and commercialization to improve outcomes through scalable and accurate telehealth services.
This presentation discusses forward-looking statements and risks associated with them. It notes that while management believes expectations in forward-looking statements are reasonable, actual results could differ materially due to known and unknown risks and uncertainties. The presentation also notes that views expressed as of the date may change in the future.
1) Alcon and Google have partnered to develop "smart lens" technology to address unmet medical needs in eye care, such as treating cataracts, age-related macular degeneration, glaucoma, and presbyopia.
2) The collaboration aims to create glucose-sensing contact lenses to help diabetics manage their condition, and accommodating contact lenses or IOLs to restore near vision for presbyopes.
3) While smart lenses offer advantages like ease of use and data sharing, challenges include ensuring patient privacy as health data is collected and regulatory hurdles in approving new mobile medical devices.
1) The document discusses Ophthotech's development of new therapies for age-related macular degeneration (AMD), including their lead drug Fovista.
2) Fovista is currently in Phase 3 clinical trials in combination with anti-VEGF drugs to treat wet AMD, with initial data expected in 4Q 2016.
3) Previous Phase 2b results showed Fovista in combination with Lucentis was statistically superior to Lucentis alone and had a favorable safety profile.
EMERGING APPROACHES TO COMBINATION THERAPIES IN AMD & DME - Allegro OphthalmicsHealthegy
Luminate is a first-in-class anti-integrin product in late stage development for the treatment of retinal diseases like diabetic macular edema (DME) and proliferative vitreoretinopathy (PVD). It works through novel mechanisms of action for anti-angiogenesis and vitreolysis. Phase 2b clinical trial data for DME and PVD are expected to be available in Q1 2017. Luminate has been administered to over 400 subjects safely and could offer increased durability, better safety, and new treatment options compared to existing anti-VEGF drugs.
Ocata Therapeutics is developing regenerative ophthalmology therapies using retinal pigment epithelium (RPE) cells derived from pluripotent stem cells. Data from completed Phase 1/2 studies in Stargardt's macular degeneration and dry age-related macular degeneration showed long-term safety and evidence that transplanted RPE cells engrafted and persisted. Ocata is initiating pivotal and Phase 2 studies to further evaluate these RPE therapies with the goal of commercial launches beginning in 2019.
Verisome (TM) a New Injectable Sustained Release and Biodegradable Intraocula...Randall Wong, M.D.
- Verisome is a new biodegradable and injectable intraocular drug delivery system that is designed to provide sustained release of medications over extended periods of time from 1 week to over 1 year.
- An ongoing Phase I clinical trial is evaluating the safety and tolerability of Verisome (IBI 20089) containing triamcinolone acetonide for the treatment of cystoid macular edema. No significant safety issues have been reported to date.
- Preliminary results from the first 10 patients in the trial suggest the Verisome system is able to control drug release as intended and reduce macular edema without serious adverse events. Further Phase II testing is planned to begin in the fourth quarter
This document summarizes corporate milestones and pipeline for Envisia Therapeutics, a company developing ophthalmic drug delivery systems. Key points include:
- The company was formed in 2013 and has raised $25 million in funding.
- They are developing long-acting biodegradable formulations of travoprost (ENV515) for glaucoma and difluprednate (ENV905) for post-cataract inflammation. Clinical trials are underway.
- Their PRINT technology platform can produce particles from 100nm to 1000um and is being used to develop extended release formulations of small molecules and biologics for front and back of the eye diseases.
1) Ocata Therapeutics presented a corporate presentation on their RPE cell therapy for macular degeneration.
2) Their phase 1/2 clinical trials showed signs of safety and efficacy, with anatomical and functional evidence of repair. Some patients showed visual acuity gains after over 3 years.
3) They are initiating pivotal trials for Stargardt's Macular Degeneration and a phase 2 trial for dry AMD to further evaluate the safety and efficacy of their RPE transplantation therapy.
EyeGate Pharma CEO Investor Presentation to BioCEO 2018Mike Garanzini
EyeGate Pharmaceuticals has two drug delivery platforms for eye disorders - an ocular bandage gel (OBG) eye drop and an iontophoresis delivery system. The OBG eye drop is a crosslinked hyaluronic acid gel that accelerates wound healing in the cornea. It has completed clinical trials showing accelerated re-epithelialization of corneal wounds. The iontophoresis system delivers corticosteroids into the eye using a mild electrical current, reducing the need for eye drops. Its lead product EGP-437 is being studied for inflammation after cataract surgery and uveitis, with clinical trials demonstrating trends of better outcomes than placebo.
ForSight VISION5 is developing an ocular insert system to deliver sustained drug therapy to the eye over 3-6 months for conditions like glaucoma. Their lead product is in Phase 2 trials using a prostaglandin analog to lower intraocular pressure. The insert is designed to eliminate the need for daily eye drops and improve patient compliance. Clinical studies show the insert is well-tolerated and has high retention rates. ForSight VISION5 aims to address the large unmet need of non-compliant glaucoma patients through this novel, non-invasive drug delivery approach.
Central Retinal Vein OcclUsIon (CRUISE) Study - Cruise trialLaxmi Eye Institute
Ranibizumab injections led to improved visual acuity and resolution of macular edema compared to sham injections in patients with central retinal vein occlusion. At 6 months, patients receiving 0.3 mg or 0.5 mg ranibizumab were twice as likely to have a visual acuity of 20/40 or better compared to the sham group. Ranibizumab also significantly reduced central foveal thickness within 7 days, suggesting retinal edema in CRVO is primarily VEGF-mediated. While ranibizumab was effective, longer term studies are needed to determine optimal duration of treatment and benefits in less severe cases.
Anterior Segment Company Showcase - Sensimed AGHealthegy
Anterior Segment Company Showcase - Sensimed AG at OIS@AAO 2016.
Presenter:
David Bailey, CEO
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For more ophthalmology innovation
Visit us at www.ois.net
This document describes a clinical trial protocol to evaluate the efficacy and safety of Loteprednol Etabonate Ophthalmic Suspension 1% w/v compared to Loteprednol Etabonate Ophthalmic Suspension 0.5% w/v for the treatment of post-operative inflammatory conditions of the eye. The randomized, double-blind, parallel group trial will enroll 206 subjects to receive either the 1% or 0.5% suspension twice daily for 18 days. The primary endpoint is the proportion of subjects with complete resolution of anterior chamber cells at day 8. Secondary endpoints include resolution of anterior chamber flare and pain scores. The trial eligibility criteria, design, procedures, and assessments are provided in
1) ForSight Vision5 is developing the Helios Ocular Insert, a biodegradable insert placed in the eye by a physician that is designed to slowly release bimatoprost over 6 months to lower intraocular pressure and improve patient adherence to glaucoma treatment.
2) Phase 1 and 2 clinical trials showed the insert was well-tolerated and provided sustained IOP-lowering for up to 6 months from a single administration.
3) The company plans to begin a Phase 3 clinical trial program in early 2016 to support regulatory approval and commercialization of the Helios Insert for glaucoma.
This presentation discusses RES-529, a first-in-class PI3K/Akt/mTOR pathway inhibitor being developed for ophthalmology and oncology indications. Preclinical studies show RES-529 inhibits VEGF-induced angiogenesis and permeability. Phase I clinical trials in wet age-related macular degeneration (AMD) show a favorable safety profile and preliminary signs of efficacy. Upcoming studies will evaluate subconjunctival administration in AMD patients. RES-529 also shows preclinical efficacy in glioblastoma models and has received FDA orphan drug designation for this indication. Planned studies will initiate a Phase I/II trial in glioblastoma patients in 2016.
Ablynx Financial Presentation Half Year Results 2014Ablynx ABLX
1) Ablynx reported strong financial and clinical progress in the first half of 2014, with revenues increasing 72% and a 40% reduction in net loss compared to the same period in 2013.
2) Clinically, caplacizumab achieved proof-of-concept for the treatment of acquired thrombotic thrombocytopenic purpura, and preparations were underway to start a Phase III trial in 2015. Phase I trials were also initiated for other programs.
3) Partnership wise, Merck Serono and AbbVie advanced programs in clinical trials, and a new collaboration was announced with Merck & Co. worth up to €1.7 billion in potential milestones.
National Skin Centre Dermatology Research NewsletterJ W
Dr. Tey Hong Liang was awarded the NMRC TA grant for his new research study on developing alternative treatments for keloids using drug-free microneedles containing hyaluronic acid. The project aims to create a safe, easy-to-administer, and cost-effective treatment that could benefit patients with limited access to standard treatments. A/Prof Mark Tang was interviewed about an ongoing drug trial for Dupilumab, a monoclonal antibody that could be an effective alternative to steroids for treating atopic dermatitis. The newsletter provides updates on research activities at the National Skin Centre including awards, grants, recruitment needs for studies, and a farewell dinner for a departing clinical research fellow.
1) The presentation discusses clinical trial results from Ocata Therapeutics' RPE transplantation therapy for dry age-related macular degeneration (AMD) and Stargardt's macular dystrophy (SMD). Safety has been demonstrated over 1-4 years with no adverse events, and efficacy signals include vision improvement or stability.
2) Ocata is initiating a pivotal trial for SMD in Europe and a Phase 2 trial for dry AMD, with potential approval and commercial launch for SMD in 2019. Additional clinical programs are outlined for other ocular diseases.
3) Preclinical research demonstrates the RPE layer is vital for photoreceptor health, and Ocata aims to transplant new R
The document provides an overview and summary of developments in ophthalmology in 2014. Some key points:
- The 7th Annual OIS@AAO conference had over 750 attendees from 32 states and 22 countries representing various sectors.
- The FDA approved 4 new ophthalmic drugs in 2014 including treatments for glaucoma, cataract surgery pain/miosis, and diabetic macular edema.
- Clinical trials are ongoing for several potential new treatments for wet AMD, DME, dry eye disease, uveitis, and glaucoma that could report data in 2015.
This document provides an overview of Advanced Cell Technology's annual meeting on regenerative medicine. The meeting will take place on October 22, 2013 in Palm Springs, CA.
The CEO update discusses ACT's progress in resolving past issues, developing clinical trials for retinal pigment epithelium transplants to treat dry AMD and Stargardt's disease, and advancing mesenchymal stem cell research.
The science update outlines ACT's research programs in developing stem cell treatments for various eye diseases from pluripotent stem cells, progress in clinical trials, and next steps to scale up production of retinal pigment epithelium cells and other ocular cell types for clinical applications.
The annual meeting presentation summarizes ACT's regenerative medicine programs and provides updates. Key points include:
1) ACT has concluded a successful meeting with its OAB and developed a 2014 goal-driven plan focusing on advancing its retinal pigment epithelium and ophthalmic programs as well as moving mesenchymal stem cell activities toward the clinic.
2) ACT has a robust development pipeline for ophthalmology and stem cell therapies providing multiple opportunities for commercialization and partnerships. Programs include treatments for dry AMD, Stargardt's disease, myopia, glaucoma, corneal disease, and mesenchymal stem cells.
3) Upcoming clinical milestones in the fourth quarter of 2013
This document provides an overview of a company called Aerie Pharmaceuticals and their glaucoma products. It summarizes clinical trial results for Rhopressa and Roclatan, which are novel glaucoma drugs. Rhopressa achieved non-inferiority compared to timolol in lowering eye pressure over 6 months in multiple trials. A pilot study found Rhopressa to be effective at lowering pressure during both day and night. Roclatan was statistically superior to its individual components latanoprost and Rhopressa in lowering pressure at all timepoints in a phase 3 trial. Both drugs were generally well tolerated with conjunctival hyperemia as the most common side effect.
This document provides an overview of a company called Aerie Pharmaceuticals and their glaucoma products. It summarizes results from clinical trials of their two leading investigational drug candidates, Rhopressa and Roclatan. Rhopressa achieved non-inferiority compared to timolol in lowering eye pressure over 6 months in phase 3 trials. A pilot study also found Rhopressa to be effective at lowering pressure during nighttime hours. Roclatan was found to be statistically superior to its individual components, latanoprost and Rhopressa, in lowering pressure at all timepoints in a phase 3 trial. Both drugs demonstrated favorable safety profiles in clinical testing.
This document discusses small aperture optics for improving vision, including the KAMRA corneal inlay and IC-8 intraocular lens. It summarizes clinical studies that show the KAMRA inlay and IC-8 IOL provide an extended depth of focus, improving intermediate and near vision while maintaining good distance vision. The document also notes that these technologies are capturing more market share and have the potential to address a significant segment of patients with aberrated corneas.
This document provides an overview of Avedro, the world leader in corneal remodeling. Key points include:
- Avedro has developed the first and only FDA-approved corneal cross-linking platform for treating keratoconus and corneal ectasia. They have installed 1500 systems and performed 250,000 treatments.
- Their 2017 plans are to expand into keratoconus and refractive markets, drive toward reimbursement, and conduct 14 clinical studies on epi-on procedures and refractive applications.
- They have a proven cross-linking mechanism of action that strengthens the cornea to stabilize keratoconus and ectasia. Their PiXL technique allows for non-invasive zonal strengthening to induce corneal
The document discusses Cassini, a corneal imaging system that provides comprehensive analysis of the anterior and posterior cornea to reduce refractive surprises. It has 6 key features: 1) total corneal analysis, 2) ocular surface diagnostics, 3) iris registration, 4) integrated surgical workflow, 5) data mining, and 6) proactive solutions. Cassini provides valuable pre-op information and seamlessly integrates with other technologies. It uses multi-colored LEDs and 2nd Purkinje imaging to map total corneal astigmatism. Cassini has been used in over 300,000 cataract patients to date. It can drive premium procedures and adoption of premium IOLs while also streamlining surgical workflows.
The HARMONI Modular IOL System provides a stable foundation through a reliable base and optimized rotational stability. Its modular design allows for versatile control through safe and easy optic exchangeability and upgradeability to provide refractive care for a patient's lifetime. Clinical trials show the HARMONI IOL has best-in-class stability and visual performance that rivals traditional IOLs, while offering the ability to fine tune outcomes through optic exchange. The system aims to provide complete confidence in surgical outcomes without added costs or changes to routines.
Ophthalmology Innovation Showcase 1 - InnFocus (A Santen Company)Healthegy
The InnFocus MicroShunt is designed to be the first FDA-approved standalone procedure to treat mild, moderate, and severe open-angle glaucoma by lowering intraocular pressure under 15 mmHg without eye drops in most patients. It uses a unique SIBS material that has been proven biocompatible and shown not to degrade or provoke scarring over 15 years of use in over 1 million patients. Clinical trials have demonstrated the MicroShunt's ability to successfully lower IOP long-term while maintaining an acceptable safety profile. The MicroShunt offers surgeons a potential replacement for trabeculectomy and tubes with advantages in both safety and operating time.
The document discusses the Hydrus Microstent, a minimally invasive glaucoma surgery (MIGS) device that provides a tri-modal mechanism of action to lower intraocular pressure. Over 3,200 patients have been treated globally using the Hydrus Microstent. Clinical studies and a large global registry have shown the Hydrus Microstent to provide superior outcomes compared to other MIGS devices, with a 20% reduction in diurnal intraocular pressure and increased treatment response rates. The Hydrus Microstent expands treatment opportunities for both standalone glaucoma procedures and combined cataract/glaucoma surgeries.
The LacriPen is a handheld portable device that can measure osmolality and biomarkers from tears in 1 second using surface plasmon resonance. It has achieved a goal of ±2 mOsms/L for osmolality measurements and can detect MMP-9 concentrations from 1-200 ng/ml with precision of ±5 ng/ml. Clinical testing of the LacriPen's ability to measure osmolality and detect smart diagnostics has been approved and initial testing has been completed. The portable design allows for point-of-care diagnostics without the need for anesthesia or eyelid scraping.
Ophthalmology Innovation Showcase 1 - Mati TherapeuticsHealthegy
This document discusses a punctal plug drug delivery system called Evolute. It can deliver drugs to treat various ocular diseases like glaucoma, allergies, inflammation, and dry eye. Clinical trials showed excellent plug retention rates over 12 weeks. The system offers benefits like a flexible drug delivery profile, non-invasive application, steady drug elution unlike eye drops, and comfort. It is developing formulations of nepafenac, difluprednate, travoprost, olopatadine, and cyclosporine to treat conditions like post-cataract pain/inflammation and glaucoma. The company has a strong intellectual property position and plans upcoming clinical trials.
ZeptoTM is a device that uses the Purkinje image to anchor cataract surgery on the visual axis. It completed a US clinical trial in 80 days and was submitted to the FDA for 510(k) clearance in March 2017. The device has launched in India, Germany, and is planned for the US summer 2017. Development is also underway for an automated ZeptoTM for posterior capsulotomy. ZeptoTM aims to increase practice efficiency, allow for difficult cases to be performed easily and safely, and has the potential to redefine cataract surgery.
The document expresses gratitude but does not provide any further details. It is a very short document consisting of only two words with no other context provided.
The document discusses an artificial intraocular lens (AIOL) called the FluidVision that mimics the eye's natural accommodative process. It is the first true shape changing, fluid-driven IOL. Early results from a 23 patient pilot study show promising results with a straightforward surgical technique. Bench testing shows the FluidVision provides excellent image quality over a range of powers as it continuously varies between far and near focal points by inflating and deflating the lens using fluid movements. PowerVision is developing additional innovations like a toric version and post-implant adjustment capabilities.
The document discusses Presbia Flexivue Microlens, an investigational intracorneal inlay to treat presbyopia. It notes that there are 1.8 billion presbyopes worldwide and ophthalmologists are motivated to treat this large market. The technology involves implanting a small hydrophilic acrylic lens in the cornea using existing femtosecond lasers. The author's clinical experience found the procedure had a short learning curve, excellent uncorrected near vision, and distance vision was unaffected. The inlay shows potential for treating presbyopia, improving vision after cataracts or LASIK.
Presbyopia Therapies is developing LiquidVision Eye Drops to treat presbyopia, a large global market affecting most people over age 50. The drops aim to improve near vision without distance vision blur for 5+ hours after a single daily dose. Currently, the main treatment options are reading glasses or contact lenses. A phase 2a trial in 2016 showed the drops improved uncorrected near vision versus placebo. A phase 2b trial beginning in Q2 2017 aims to demonstrate a 30 minute onset and 5+ hour duration with a 3-line improvement in near vision. The company hopes to create a new global market category for the daily treatment of presbyopia.
This document summarizes information about the VisAbility Micro-Insert System, an investigational device for treating presbyopia. It provides details on the clinical trial results showing the device improved near vision without compromising distance vision. Over multiple time periods, a high percentage of patients achieved good near vision both with and without glasses. The device also showed stability in refractive error and high patient satisfaction rates. The summary concludes with benefits of the VisAbility procedure compared to other presbyopia surgeries, such as preserving full range of focus and stereopsis while having a superior safety profile.
The document discusses market research data on the presbyopic market in the US and patient outcomes and satisfaction rates for Raindrop vision correction surgery. It finds that there are over 28 million potential patients in the US, with 71% seeking an ophthalmologist for the procedure. Real-world data shows 99% of patients achieving less than 20/20 distance vision and 78% less than J3 near vision, with a low 2.5% explant rate. Surgeon, patient, and reorder satisfaction rates are over 90% based on recent surveys.
SightGlass Vision has developed lenses that can safely and effectively reduce myopia progression in children. Myopia is a growing global problem, with hundreds of millions expected to suffer vision impairment due to complications if left untreated. Current solutions are only marginally effective and carry safety risks. SightGlass lenses work by providing peripheral blur and reducing peripheral hyperopia based on clinical trials, demonstrating over a 90% reduction in axial eye growth. The company is seeking funding to conduct a pivotal study and launch the lenses globally to address this major public health issue.
The document discusses the benefits of exercise for mental health. Regular physical activity can help reduce anxiety and depression and improve mood and cognitive functioning. Exercise causes chemical changes in the brain that may help protect against mental illness and improve symptoms.
The Commonwealth Fund - Putting the Patient at the Center of the Digital Univ...Healthegy
Keynote Address - Presentation by Commonwealth Fund at Digital Healthcare Innovation Summit 2016
Participant:
David Blumenthal, MD, MPP, President & CEO – Commonwealth Fund
Introduced By:
Robert Mittendorff, MD, MBA, Partner – Norwest Venture Partners
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The facial nerve, also known as cranial nerve VII, is one of the 12 cranial nerves originating from the brain. It's a mixed nerve, meaning it contains both sensory and motor fibres, and it plays a crucial role in controlling various facial muscles, as well as conveying sensory information from the taste buds on the anterior two-thirds of the tongue.
End-tidal carbon dioxide (ETCO2) is the level of carbon dioxide that is released at the end of an exhaled breath. ETCO2 levels reflect the adequacy with which carbon dioxide (CO2) is carried in the blood back to the lungs and exhaled.
Non-invasive methods for ETCO2 measurement include capnometry and capnography. Capnometry provides a numerical value for ETCO2. In contrast, capnography delivers a more comprehensive measurement that is displayed in both graphical (waveform) and numerical form.
Sidestream devices can monitor both intubated and non-intubated patients, while mainstream devices are most often limited to intubated patients.
As Mumbai's premier kidney transplant and donation center, L H Hiranandani Hospital Powai is not just a medical facility; it's a beacon of hope where cutting-edge science meets compassionate care, transforming lives and redefining the standards of kidney health in India.
At Malayali Kerala Spa Ajman, Full Service includes individualized care for every client. We specifically design each massage session for the individual needs of the client. Our therapists are always willing to adjust the treatments based on the client's instruction and feedback. This guarantees that every client receives the treatment they expect.
By offering a variety of massage services, our Ajman Spa Massage Center can tackle physical, mental, and emotional illnesses. In addition, efficient identification of specific health conditions and designing treatment plans accordingly can significantly enhance the quality of massaging.
At Malayali Kerala Spa Ajman, we firmly believe that everyone should have the option to experience top-quality massage services regularly. To achieve that goal we offer cheap massage services in Ajman.
If you are interested in experiencing transformative massage treatment at Malayali Kerala Spa Ajman, you can use our Ajman Massage Center WhatsApp Number to schedule your next massage session.
Contact @ +971 529818279
Visit @ https://malayalikeralaspaajman.com/
VEDANTA AIR AMBULANCE SERVICES IN REWA AT A COST-EFFECTIVE PRICE.pdfVedanta A
Air Ambulance Services In Rewa works in close coordination with ground-based emergency services, including local Emergency Medical Services, fire departments, and law enforcement agencies.
More@: https://tinyurl.com/2shrryhx
More@: https://tinyurl.com/5n8h3wp8
Digital Health in India_Health Informatics Trained Manpower _DrDevTaneja_15.0...DrDevTaneja1
Digital India will need a big trained army of Health Informatics educated & trained manpower in India.
Presently, generalist IT manpower does most of the work in the healthcare industry in India. Academic Health Informatics education is not readily available at school & health university level or IT education institutions in India.
We look into the evolution of health informatics and its applications in the healthcare industry.
HIMMS TIGER resources are available to assist Health Informatics education.
Indian Health universities, IT Education institutions, and the healthcare industry must proactively collaborate to start health informatics courses on a big scale. An advocacy push from various stakeholders is also needed for this goal.
Health informatics has huge employment potential and provides a big business opportunity for the healthcare industry. A big pool of trained health informatics manpower can lead to product & service innovations on a global scale in India.
Mental Health and well-being Presentation. Exploring innovative approaches and strategies for enhancing mental well-being. Discover cutting-edge research, effective strategies, and practical methods for fostering mental well-being.
CHAPTER 1 SEMESTER V COMMUNICATION TECHNIQUES FOR CHILDREN.pdfSachin Sharma
Here are some key objectives of communication with children:
Build Trust and Security:
Establish a safe and supportive environment where children feel comfortable expressing themselves.
Encourage Expression:
Enable children to articulate their thoughts, feelings, and experiences.
Promote Emotional Understanding:
Help children identify and understand their own emotions and the emotions of others.
Enhance Listening Skills:
Develop children’s ability to listen attentively and respond appropriately.
Foster Positive Relationships:
Strengthen the bond between children and caregivers, peers, and other adults.
Support Learning and Development:
Aid cognitive and language development through engaging and meaningful conversations.
Teach Social Skills:
Encourage polite, respectful, and empathetic interactions with others.
Resolve Conflicts:
Provide tools and guidance for children to handle disagreements constructively.
Encourage Independence:
Support children in making decisions and solving problems on their own.
Provide Reassurance and Comfort:
Offer comfort and understanding during times of distress or uncertainty.
Reinforce Positive Behavior:
Acknowledge and encourage positive actions and behaviors.
Guide and Educate:
Offer clear instructions and explanations to help children understand expectations and learn new concepts.
By focusing on these objectives, communication with children can be both effective and nurturing, supporting their overall growth and well-being.
Hypertension and it's role of physiotherapy in it.Vishal kr Thakur
This particular slides consist of- what is hypertension,what are it's causes and it's effect on body, risk factors, symptoms,complications, diagnosis and role of physiotherapy in it.
This slide is very helpful for physiotherapy students and also for other medical and healthcare students.
Here is summary of hypertension -
Hypertension, also known as high blood pressure, is a serious medical condition that occurs when blood pressure in the body's arteries is consistently too high. Blood pressure is the force of blood pushing against the walls of blood vessels as the heart pumps it. Hypertension can increase the risk of heart disease, brain disease, kidney disease, and premature death.
This particular slides consist of- what is Pneumothorax,what are it's causes and it's effect on body, risk factors, symptoms,complications, diagnosis and role of physiotherapy in it.
This slide is very helpful for physiotherapy students and also for other medical and healthcare students.
Here is a summary of Pneumothorax:
Pneumothorax, also known as a collapsed lung, is a condition that occurs when air leaks into the space between the lung and chest wall. This air buildup puts pressure on the lung, preventing it from expanding fully when you breathe. A pneumothorax can cause a complete or partial collapse of the lung.
1. Luminate® for the
Treatment of Retinal Eye Diseases
Ophthalmology Innovation Summit – October 2014
Vicken Karageozian, MD
Chief Technical Officer
Copyright 2014 by Allegro Ophthalmics, LLC, All Rights Reserved
2. Allegro Ophthalmics: Integrin Peptide Therapy
for Vitreo-Retinal Eye Diseases
ü Mid-stage biotechnology company
ü In multiple Phase 2 US Studies in DME &
VMT
ü First in class anti-integrin MoA to treat neo-
vascular eye diseases and induce
vitreolysis
ü Clearly defined clinical and regulatory
endpoints
ü Strong safety profile
ü Solid efficacy data in multiple indications
Copyright 2014 by Allegro Ophthalmics, LLC, All Rights Reserved 2
3. Allegro Ophthalmics: Integrin Peptide Therapy
for Vitreo-Retinal Eye Diseases
ü Differentiated from existing anti-VEGF therapy
— Unprecedented durability, benefits last
3-4 months off treatment
— Ability to treat anti-VEGF plateaued patients
ü Composition of matter patents pending
ü Commercial opportunities validated by third
party market research
ü Collaboration with strategic partners
ü Experienced management team
Copyright 2014 by Allegro Ophthalmics, LLC, All Rights Reserved 3
4. Luminate® Mechanisms of
Action & Indications
Anti-angiogenesis Vitreolysis
Diabetic
Macular Edema
Wet Age-Related
Macular Degeneration
Vitreomacular
Traction
PVD for Diabetic
Retinopathy
4.0MM patients in US
today – largest cause of
blindness under 55
1.5MM patients in US as of 2010;
projected 3MM by 2020 – largest
cause of blindness over 65
Rate of occurrence between
0.30 and 0.35 per 100 over
the age of 40
More than 8 million diabetics
in the US develop DR,
increasing 6% each year
Copyright 2014 by Allegro Ophthalmics, LLC, All Rights Reserved 4
5. Luminate® Human Clinical Trial Results
— Excellent safety profile with more than 350 human intravitreal
injections
— Robust clinical response in DME, wet AMD, and VMT/PVD
— Potent enough for monotherapy
— Extended durability: 3-4 months off treatment
— Anti-VEGF levels of BCVA and OCT improvements
— Improvements seen in anti-VEGF plateaued subjects
Copyright 2014 by Allegro Ophthalmics, LLC, All Rights Reserved 5
6. Luminate® Clinical Pipeline
In ProgressCompleted Planned
Phase I Phase II Phase III
Anti-angiogenesis
Diabetic Macular Edema
Wet Age-Related Macuclar Degeneration
Vitreolysis
Vitreomacular Traction
Posterior Vitreous Detachment for DR
Clinical
Pre-Clinical Commercial
Phase&Ib/IIa&
Phase&Ib&&
Phase&II&
Phase&I&
Phase&I& 2016.2018&Phase&IIb&
2016.2019&
2015.2017&
2015.2019&Phase&IIb&
Copyright 2014 by Allegro Ophthalmics, LLC, All Rights Reserved 6
Anti-angiogenesis
Diabetic Macular Edema
Wet Age-Related Macular Degeneration
Vitreolysis
Vitreomacular Traction
Posterior Vitreous Detachment for DR
7. Luminate® Clinical Trial Status
7Copyright 2014 by Allegro Ophthalmics, LLC, All Rights Reserved
161 patients enrolled in clinical trials to date
150 additional patients expected to complete DME Phase 2 protocol in 2014-15
Study Details Initiated
Enrollment
Complete
Readout Efficacy
P1 DME + PVD
n=15
E. Europe
Q1 2011 Q4 2011 Oct 2011
8 of 15 subjects improved 3-5 lines
3 months off-treatment
6 of 11 patients developed total
PVD by day 90
P2b DME + PVD
n=150
US (30 sites)
Q4 2014 Sept 2015 Q1 2016
P1b/2a DME Combo
n=40
Mexico, E. Europe
Sep 2013 Q4 2014 H1 2015
P1b/2a Wet AMD
n=22
Mexico, E. Europe
Dec 2012 Q4 2013 Jun 2014
Peak avg. BCVA improvement for
3.2 mg: 5.1 letters 60 days
off-treatment, holding 120 days
off-treatment
P2 VMT
n=84
US, E. Europe
Nov 2013 Jun 2014 Oct 2014
8. US Phase IIb DME + PVD Study
— Randomized, controlled, double masked study
— Study designed to minimize risk and increase repeatability
— Built upon design and results of Phase I DME Study
— Replicates dosage, formulation and dosing schedule
— Efficacy endpoints focused on:
— OCT central subfield thickness and BCVA
— Increased durability: efficacy 3 and 4 months off tx in monotherapy
Copyright 2014 by Allegro Ophthalmics, LLC, All Rights Reserved 8
— Study initiated October 2014
9. US Phase IIb DME Study + PVD Study
9Copyright 2014 by Allegro Ophthalmics, LLC, All Rights Reserved
washout or
treatment naïve
Baseline 1 2 3 4 5 6
Months
● 150 subjects in 5 arms
● 1.0, 2.0, 3.0mg Luminate®
● Avastin®
● Focal Laser
● 3 monthly loading doses, followed monthly
● Luminate® readouts at three and four months off tx
● Duke University Reading Center
10. • Excellent Safety Profile
• No patients lost vision
• No SAEs and AEs were mild
and typically injection related
• Mean peak BCVA improvement:
11 letters (or ~2 lines)
2 months off treatment
• 8 patients improved
3-5 lines
• Improvements held
3+ months off treatment
• Corresponding improvement
of BCVA and CMT
Phase I DME Study: BCVA Improvement
10Copyright 2014 by Allegro Ophthalmics, LLC, All Rights Reserved
9.7
9.3
11.0 11.0 9.1
0
4
8
12
0 Days 30 Days 60 Days 90 Days 120 Days 150 Days
0.0
N=15
30 Days Off
Treatment
60 Days Off
Treatment
90 Days Off
Treatment
Improvement in BCVA (ETDRS letters
converted from logMAR)
11. • Mean peak
improvement in OCT
CMT: 31% for all
subjects
• Improvement held until
Day 150 (3 months off
treatment)
Phase I DME Study: Change in OCT CMT
11Copyright 2014 by Allegro Ophthalmics, LLC, All Rights Reserved
461
439
390 359
387
350
450
550
0 Days 30 Days 60 Days 90 Days 120 Days 150 Days
519
N=15
30 Days Off
Treatment
60 Days Off
Treatment
90 Days Off
Treatment
Central Macular Thickness
(microns)
12. Phase Ib/IIa Wet AMD Study
— 6-month, dose-ranging study in Wet AMD
— 3 monthly injections, monotherapy
— 4 months of off-treatment follow-up
— No SAEs reported
— 7 of 7 subjects in 3.2mg dose improved ~4-5 letters in BCVA
measured up to 4 months off-treatment in monotherapy
45 day washout or
treatment naïve
Baseline 1 2 3 4 5 6
Months
Copyright 2014 by Allegro Ophthalmics, LLC, All Rights Reserved 12
13. Phase II VMT Study (In Progress)
— 3-month study in US and E. Europe
— Double masked, randomized,
placebo-controlled
— Primary endpoint: resolution of VMT
— Duke University Reading Center
— Fully enrolled
— 84 subjects in 3 arms
Copyright 2014 by Allegro Ophthalmics, LLC, All Rights Reserved 13
14. Moving Forward With Luminate®
ü Differentiated mechanisms of action with
unique benefits
— Anti-integrin vs. ant-VEGF
— Increased durability: 3-4 months off tx
— Ability to tx anti-VEGF plateaued pts
ü Strong safety profile with ~350 human tx
ü Solid efficacy data in multiple vitreo-retinal
indications
ü Moving beyond PoC/Phase 2 studies toward
Phase 3 in multiple indications
ü Strong commitment from world class SAB
ü Leveraging strategic partnerships & financial
investments to execute to commercialization
Copyright 2014 by Allegro Ophthalmics, LLC, All Rights Reserved 14