Posterior Segment Company Showcase - Graybug Vision at OIS@AAO 2016.
Presenter:
Jeffrey Cleland, PhD, President & CEO
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Public Device & Biopharma Ophthalmology Company Showcase - Adverum Biotechnol...Healthegy
Public Device & Biopharma Ophthalmology Company Showcase - Adverum Biotechnologies at OIS@AAO 2016.
Presenter:
Samuel B. Barone, MD SVP, Clinical Development
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Public Device & Biopharma Ophthalmology Company Showcase - QLTHealthegy
Public Device & Biopharma Ophthalmology Company Showcase - QLT at OIS@AAO 2016.
Presenter:
David Saperstein, MD, Chief Medical Advisor
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Public Device & Biopharma Ophthalmology Company Showcase - Inotek Pharmaceuti...Healthegy
Public Device & Biopharma Ophthalmology Company Showcase - Inotek Pharmaceuticals at OIS@AAO 2016.
Presenter:
David Southwell, President & CEO
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Posterior Segment Company Showcase - PanOpticaHealthegy
Posterior Segment Company Showcase - PanOptica at OIS@AAO 2016.
Presenter:
Paul Chaney, Co-Founder, President & CEO
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Posterior Segment Company Showcase - Notal visionHealthegy
Posterior Segment Company Showcase - Notal vision at OIS@AAO 2016.
Presenter:
Quinton Oswald, CEO
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Aerie Pharmaceuticals is developing Rhopressa and Roclatan as once-daily eye drops to lower intraocular pressure for glaucoma. Rhopressa demonstrated efficacy in Phase 3 trials and Aerie expects to file an NDA in Q3 2016. Roclatan achieved all endpoints in a Phase 2b trial and is now in Phase 3 trials. Preclinical research also shows Rhopressa may modify diseased tissue and increase blood flow in the eye. Aerie is exploring AR-13154 for wet AMD which showed lesion size reduction exceeding the leading product in studies. The company collaborates with other organizations on delivery technologies and product candidates for the front and back of the eye.
Public Device & Biopharma Ophthalmology Company Showcase - Adverum Biotechnol...Healthegy
Public Device & Biopharma Ophthalmology Company Showcase - Adverum Biotechnologies at OIS@AAO 2016.
Presenter:
Samuel B. Barone, MD SVP, Clinical Development
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Public Device & Biopharma Ophthalmology Company Showcase - QLTHealthegy
Public Device & Biopharma Ophthalmology Company Showcase - QLT at OIS@AAO 2016.
Presenter:
David Saperstein, MD, Chief Medical Advisor
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Public Device & Biopharma Ophthalmology Company Showcase - Inotek Pharmaceuti...Healthegy
Public Device & Biopharma Ophthalmology Company Showcase - Inotek Pharmaceuticals at OIS@AAO 2016.
Presenter:
David Southwell, President & CEO
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Posterior Segment Company Showcase - PanOpticaHealthegy
Posterior Segment Company Showcase - PanOptica at OIS@AAO 2016.
Presenter:
Paul Chaney, Co-Founder, President & CEO
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Posterior Segment Company Showcase - Notal visionHealthegy
Posterior Segment Company Showcase - Notal vision at OIS@AAO 2016.
Presenter:
Quinton Oswald, CEO
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Aerie Pharmaceuticals is developing Rhopressa and Roclatan as once-daily eye drops to lower intraocular pressure for glaucoma. Rhopressa demonstrated efficacy in Phase 3 trials and Aerie expects to file an NDA in Q3 2016. Roclatan achieved all endpoints in a Phase 2b trial and is now in Phase 3 trials. Preclinical research also shows Rhopressa may modify diseased tissue and increase blood flow in the eye. Aerie is exploring AR-13154 for wet AMD which showed lesion size reduction exceeding the leading product in studies. The company collaborates with other organizations on delivery technologies and product candidates for the front and back of the eye.
Posterior Segment Company Showcase - Ohr pharmaceuticalHealthegy
Posterior Segment Company Showcase - Ohr pharmaceutical at OIS@AAO 2016.
Presenter:
Jason Slakter, CEO
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Spark Therapeutics is developing gene therapies for genetic disorders including SPK-RPE65 for retinal diseases. SPK-RPE65 achieved highly statistically significant results in a pivotal Phase 3 trial, demonstrating long-lasting benefits on vision tests over 3 years. If approved, it could be the first gene therapy approved in the US for a genetic disease. Spark is applying its validated AAV gene therapy platform to expand its pipeline to additional retinal diseases and indications.
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.
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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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.
Posterior Segment Company Showcase - Aura BiosciencesHealthegy
Posterior Segment Company Showcase - Aura Biosciences at OIS@AAO 2016.
Presenter:
Elisabet de los Pinos, CEO
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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.
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 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.
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 - AGTCHealthegy
Posterior Segment Company Showcase - AGTC at OIS@AAO 2016.
Presenter:
Sue Washer, President & CEO
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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.
Public Device & Biopharma Ophthalmology Company Showcase - pSividaHealthegy
Public Device & Biopharma Ophthalmology Company Showcase - pSivida at OIS@AAO 2016.
Presenter:
Nancy Lurker, President & CEO
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Ophthalmic Innovation 2016 - "A View From The AAO"Healthegy
Ophthalmic Innovation 2016 - "A View From The AAO"
Presenter:
David Parke, II, MD, CEO
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Posterior Segment Company Showcase - Allegro OphthalmicsHealthegy
The document summarizes results from a phase 2b clinical trial of Luminate, a novel anti-integrin product being developed by Allegro Ophthalmics for the treatment of retinal diseases. The trial met its primary endpoint, showing Luminate was non-inferior to Avastin for improving visual acuity in patients with diabetic macular edema, with half as many injections. Luminate also met secondary endpoints for anatomical improvements measured by OCT. The results demonstrate the potential for Luminate as a well-tolerated monotherapy option with 12 weeks of durability through a new mechanism of action.
Public Device & Biopharma Ophthalmology Company Showcase - OmerosHealthegy
Public Device & Biopharma Ophthalmology Company Showcase - Omeros at OIS@AAO 2016.
Presenter:
Leonard M. Blum, Chief Business & Commercial Officer
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Public Device & Biopharma Ophthalmology Company Showcase - Aerie PharmaceuticalsHealthegy
This document summarizes information from Aerie Pharmaceuticals regarding their late-stage IOP-lowering products RhopressaTM and RoclatanTM. Key points include:
- RhopressaTM (netarsudil ophthalmic solution) NDA was filed in Q3 2016 based on positive results from two Phase 3 trials, Rocket 1 and Rocket 2.
- RoclatanTM (netarsudil/latanoprost ophthalmic solution) achieved statistical superiority over individual components in its Phase 3 trial Mercury 1 at all timepoints.
- Mercury 2 and Mercury 3 trials are ongoing to support the RoclatanTM NDA filing expected near year-end 2017
Posterior Segment Company Showcase - Clearside BiomedicalHealthegy
Posterior Segment Company Showcase - Clearside Biomedical at OIS@AAO 2016.
Presenter:
Daniel White, President & CEO
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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.
Posterior Segment Company Showcase - OptheaHealthegy
Posterior Segment Company Showcase - Opthea at OIS@AAO 2016.
Presenter:
Megan Baldwin, PhD, CEO & Managing Director
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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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Posterior Segment Company Showcase - Ocular TherapeutixHealthegy
Posterior Segment Company Showcase - Ocular Therapeutix at OIS@AAO 2016.
Presenter:
Amar Sawhney, PhD, President, CEO & Chairman
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Posterior Segment Company Showcase - Ohr pharmaceuticalHealthegy
Posterior Segment Company Showcase - Ohr pharmaceutical at OIS@AAO 2016.
Presenter:
Jason Slakter, CEO
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Spark Therapeutics is developing gene therapies for genetic disorders including SPK-RPE65 for retinal diseases. SPK-RPE65 achieved highly statistically significant results in a pivotal Phase 3 trial, demonstrating long-lasting benefits on vision tests over 3 years. If approved, it could be the first gene therapy approved in the US for a genetic disease. Spark is applying its validated AAV gene therapy platform to expand its pipeline to additional retinal diseases and indications.
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.
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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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.
Posterior Segment Company Showcase - Aura BiosciencesHealthegy
Posterior Segment Company Showcase - Aura Biosciences at OIS@AAO 2016.
Presenter:
Elisabet de los Pinos, CEO
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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.
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 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.
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 - AGTCHealthegy
Posterior Segment Company Showcase - AGTC at OIS@AAO 2016.
Presenter:
Sue Washer, President & CEO
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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.
Public Device & Biopharma Ophthalmology Company Showcase - pSividaHealthegy
Public Device & Biopharma Ophthalmology Company Showcase - pSivida at OIS@AAO 2016.
Presenter:
Nancy Lurker, President & CEO
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Ophthalmic Innovation 2016 - "A View From The AAO"Healthegy
Ophthalmic Innovation 2016 - "A View From The AAO"
Presenter:
David Parke, II, MD, CEO
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Posterior Segment Company Showcase - Allegro OphthalmicsHealthegy
The document summarizes results from a phase 2b clinical trial of Luminate, a novel anti-integrin product being developed by Allegro Ophthalmics for the treatment of retinal diseases. The trial met its primary endpoint, showing Luminate was non-inferior to Avastin for improving visual acuity in patients with diabetic macular edema, with half as many injections. Luminate also met secondary endpoints for anatomical improvements measured by OCT. The results demonstrate the potential for Luminate as a well-tolerated monotherapy option with 12 weeks of durability through a new mechanism of action.
Public Device & Biopharma Ophthalmology Company Showcase - OmerosHealthegy
Public Device & Biopharma Ophthalmology Company Showcase - Omeros at OIS@AAO 2016.
Presenter:
Leonard M. Blum, Chief Business & Commercial Officer
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Public Device & Biopharma Ophthalmology Company Showcase - Aerie PharmaceuticalsHealthegy
This document summarizes information from Aerie Pharmaceuticals regarding their late-stage IOP-lowering products RhopressaTM and RoclatanTM. Key points include:
- RhopressaTM (netarsudil ophthalmic solution) NDA was filed in Q3 2016 based on positive results from two Phase 3 trials, Rocket 1 and Rocket 2.
- RoclatanTM (netarsudil/latanoprost ophthalmic solution) achieved statistical superiority over individual components in its Phase 3 trial Mercury 1 at all timepoints.
- Mercury 2 and Mercury 3 trials are ongoing to support the RoclatanTM NDA filing expected near year-end 2017
Posterior Segment Company Showcase - Clearside BiomedicalHealthegy
Posterior Segment Company Showcase - Clearside Biomedical at OIS@AAO 2016.
Presenter:
Daniel White, President & CEO
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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.
Posterior Segment Company Showcase - OptheaHealthegy
Posterior Segment Company Showcase - Opthea at OIS@AAO 2016.
Presenter:
Megan Baldwin, PhD, CEO & Managing Director
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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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Posterior Segment Company Showcase - Ocular TherapeutixHealthegy
Posterior Segment Company Showcase - Ocular Therapeutix at OIS@AAO 2016.
Presenter:
Amar Sawhney, PhD, President, CEO & Chairman
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Posterior Segment Company Showcase - Apellis PharmaceuticalsHealthegy
Posterior Segment Company Showcase - Apellis Pharmaceuticals at OIS@AAO 2016.
Presenter:
Cedric Francois, MD, PhD, CEO
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Presentation from OIS@ASCRS 2016
James Brandt, MD, Principal Investigator
Video Presentation:
https://www.youtube.com/watch?v=jvIozhPMSQ8&list=PL1dmdBNnPTZJBhQxPOp0vdNg3s3wtN2yw&index=30
Presentation from OIS@ASCRS 2016
Amar Sawhney, PhD, President, CEO & Chairman
Video Presentation:
https://www.youtube.com/watch?v=nGQzo6czij0&list=PL1dmdBNnPTZJBhQxPOp0vdNg3s3wtN2yw&index=31
Posterior Segment Company Showcase - AerpioHealthegy
Posterior Segment Company Showcase - Aerpio at OIS@AAO 2016.
Presenter:
Joseph Gardner, President & CEO
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Anterior Segment Company Showcase - EnvisiaHealthegy
Anterior Segment Company Showcase - Envisia at OIS@AAO 2016.
Presenter:
Benjamin Yerxa, PhD, President
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Anterior Segment Company Showcase - Mati TherapeuticsHealthegy
Anterior Segment Company Showcase - Mati Therapeutics at OIS@AAO 2016.
Presenter:
Bob Butchofsky, Founder & CEO
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Anterior Segment Company Showcase - IvantisHealthegy
The document provides an overview of Ivantis, a company developing the Hydrus Microstent to treat glaucoma. Key points:
- Ivantis was founded in 2007 and has raised $107 million to date to develop the Hydrus Microstent, their only product, which is designed to reconstruct the eye's primary outflow pathway.
- Over 2,700 patients have been treated globally with nearly 50% of procedures as standalone surgery. Clinical trials show the Hydrus reduces eye pressure more than cataract surgery alone and allows reductions in glaucoma medications.
- Ivantis believes the Hydrus will differentiate in the crowded MIGS space by being the only device that reconstruct
Anterior Segment Company Showcase - SightLifeHealthegy
Anterior Segment Company Showcase - SightLife at OIS@AAO 2016.
Presenter:
Monty Montoya, CEO
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Presentation from OIS@ASCRS 2016
Mike Judy, CEO
Video of Presentation:
https://www.youtube.com/watch?v=G5ZfnPKlBSY&list=PL1dmdBNnPTZJBhQxPOp0vdNg3s3wtN2yw&index=13
Presentation from OIS@ASCRS 2016
Co-Moderators:
Gilbert H. Kliman, MD, Managing Director – InterWest Partners
Stephen Slade, MD
Company Presentations
Equinox | John Berdahl, MD, Founder & CEO
Presbyopia Therapies | Jim McCollum, Co-Founder
Stroma Medical | Doug Daniels, CEO
Eyenovia | Curt LaBelle, MD, Director
Wicab | Robert Beckman, President & COO
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
RETINA COMPANY SHOWCASE- Ocular TherapeutixHealthegy
Presentation by Ocular Therapeutix at OIS@ASRS 2016.
Participant:
Jonathan Talamo, MD, Chief Medical Officer- Ocular Therapeutix
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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.
Presentation by Graybug Vision at OIS@ASRS 2016.
Participant:
Graybug Vision | Jeffrey Cleland, President & CEO
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The document discusses an investigational ocular insert called the Helios Insert developed by ForSight VISION5 to treat glaucoma. Clinical trials showed the insert provided clinically significant IOP reduction for 6 months in a safe and comfortable manner. Patients and doctors preferred the insert to eye drops based on market research. ForSight VISION5 believes the insert could address the large problem of non-adherence to eye drops and fulfill an unmet need in the multibillion-dollar glaucoma market. The company is pursuing FDA approval and regulatory clearance for the insert.
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.
This document summarizes the presentation given by Michael O'Rourke, President and CEO of GrayBug, at an ophthalmology innovation summit. GrayBug is developing long-acting injectable therapies for eye diseases using proprietary microparticle drug delivery technologies. Their lead product GB-102 is being developed for wet age-related macular degeneration and has shown efficacy lasting over 4.5 times longer than ranibizumab in animal studies. GrayBug's technology aims to reduce the frequency of intravitreal injections from monthly to every 4-6 months and their microparticles have demonstrated no signs of inflammation following injection into the eye.
- IntelGenx Corp is a drug delivery company focused on oral film technologies. They have a pipeline of products using their VersaFilm and AdVersa drug delivery platforms.
- They have a state-of-the-art manufacturing facility in Montreal approved by Health Canada. Their pipeline includes products for migraine, erectile dysfunction, schizophrenia, and neurodegenerative diseases.
- They are conducting clinical trials for a Montelukast VersaFilm to treat cognitive impairment associated with neurodegenerative diseases like Alzheimer's, with promising preclinical and Phase I results shown.
- The document is an investor presentation for IntelGenx Corp from April 2018.
- It provides an overview of IntelGenx, including its business strategies, product pipeline, clinical trial results, manufacturing facilities, and leadership team.
- The presentation highlights IntelGenx's drug delivery technology platforms, focus on developing generic and repurposed products, and partnerships with pharmaceutical companies.
IntelGenx is an innovative pharmaceutical film company presenting its product pipeline and technology platforms to investors. The presentation discusses IntelGenx's oral thin film and buccal film technologies, product development strategies, business model, pipeline of products including treatments for migraines, erectile dysfunction, and brain degenerative diseases, and clinical trial results. It highlights a de-risked product candidate using montelukast to treat brain degenerative diseases and significant market opportunities for its pipeline products.
1) The document discusses resistance to anti-VEGF injections for wet age-related macular degeneration (wAMD), including treatment regimens, therapy failure, and treatment switching.
2) It finds that resistance can occur through tachyphylaxis or tolerance, and that switching therapy from ranibizumab to aflibercept or bevacizumab can be effective for patients who do not respond to or lose response to ranibizumab over time.
3) A trial switching patients to aflibercept who were incomplete responders to multiple ranibizumab injections found mean central subfield thickness decreased by 27.3 μm and 15.6% of eyes had a decrease in thickness of
The document summarizes an annual general meeting for Summit PLC held on July 18, 2012. It discusses Summit's focus on key drug development programs, including SMT C1100 for Duchenne Muscular Dystrophy, SMT 19969 for Clostridium difficile infection, and developing inhibitors of OGA for tauopathies like Alzheimer's disease. It outlines upcoming milestones for these programs within the next 12 months and an outlook that achieving these milestones could lead to commercial deals and significant value growth for the company.
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-
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.
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.
IntelGenx is a drug delivery company that develops improved versions of approved drugs using its proprietary drug delivery platforms, VersaFilm and AdVersa. Some of its pipeline products include Rizaport for migraines, Tadalafil VersaFilm for erectile dysfunction, Loxapine VersaFilm for schizophrenia, and Montelukast VersaFilm for mild cognitive impairment. The company has completed clinical trials demonstrating its products offer benefits over existing drugs such as increased bioavailability and reduced side effects. IntelGenx licenses its products to partners and retains manufacturing rights to generate revenue through milestone payments and royalties.
This investor presentation provides an overview of IntelGenx Corp., an innovative drug delivery solutions company. It discusses IntelGenx's product pipeline including oral thin film versions of migraine, erectile dysfunction, and schizophrenia/bipolar drugs. The presentation highlights IntelGenx's strategic partnerships, new manufacturing facility, strengthened management team, and financial performance over recent years. It positions IntelGenx for continued growth by leveraging its drug delivery platform and oral thin film technology.
medical management of chronic open angle glaucoma, primary angle closure glaucoma after iridotomy, normotensive glaucoma and acute angle closure attack.
Soligenix is initiating coverage with a Buy rating for their lead product orBec®, an oral therapy for GI GvHD currently in a Phase 3 trial. Prior trials show efficacy for orBec® with a localized corticosteroid and the Phase 3 trial further lowers clinical risk. The treatment of acute GI GvHD is an unmet medical need and orBec® has the potential to generate $150-300 million in revenue. Soligenix is also developing therapeutics for radiation injury and vaccines for biodefense through additional platforms.
Recent advances in degenerative diseases of the eye NishthaKhatri1
The world is advancing and so are we !
Then why not learn about recent advances in drug therapy of degenerative eye diseases
Remember our eyes can too be subjected to these degenerative diseases once we get old, hence let's learn about the new treatment modalities right here, right now !
Hope this helps !
VSN.st has developed a new tool to facilitate safe, fast, targeted, simple and repeatable injections of intraocular and suprachoroidal pharmaceuticals.
Similar to Posterior Segment Company Showcase - Graybug Vision (20)
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.
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.
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.
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
Powered by:
Healthegy
For more healthcare innovation
Visit us at Healthegy.com
Integrating Ayurveda into Parkinson’s Management: A Holistic ApproachAyurveda ForAll
Explore the benefits of combining Ayurveda with conventional Parkinson's treatments. Learn how a holistic approach can manage symptoms, enhance well-being, and balance body energies. Discover the steps to safely integrate Ayurvedic practices into your Parkinson’s care plan, including expert guidance on diet, herbal remedies, and lifestyle modifications.
Muktapishti is a traditional Ayurvedic preparation made from Shoditha Mukta (Purified Pearl), is believed to help regulate thyroid function and reduce symptoms of hyperthyroidism due to its cooling and balancing properties. Clinical evidence on its efficacy remains limited, necessitating further research to validate its therapeutic benefits.
Osteoporosis - Definition , Evaluation and Management .pdfJim Jacob Roy
Osteoporosis is an increasing cause of morbidity among the elderly.
In this document , a brief outline of osteoporosis is given , including the risk factors of osteoporosis fractures , the indications for testing bone mineral density and the management of osteoporosis
Does Over-Masturbation Contribute to Chronic Prostatitis.pptxwalterHu5
In some case, your chronic prostatitis may be related to over-masturbation. Generally, natural medicine Diuretic and Anti-inflammatory Pill can help mee get a cure.
Promoting Wellbeing - Applied Social Psychology - Psychology SuperNotesPsychoTech Services
A proprietary approach developed by bringing together the best of learning theories from Psychology, design principles from the world of visualization, and pedagogical methods from over a decade of training experience, that enables you to: Learn better, faster!
share - Lions, tigers, AI and health misinformation, oh my!.pptxTina Purnat
• Pitfalls and pivots needed to use AI effectively in public health
• Evidence-based strategies to address health misinformation effectively
• Building trust with communities online and offline
• Equipping health professionals to address questions, concerns and health misinformation
• Assessing risk and mitigating harm from adverse health narratives in communities, health workforce and health system
Rasamanikya is a excellent preparation in the field of Rasashastra, it is used in various Kushtha Roga, Shwasa, Vicharchika, Bhagandara, Vatarakta, and Phiranga Roga. In this article Preparation& Comparative analytical profile for both Formulationon i.e Rasamanikya prepared by Kushmanda swarasa & Churnodhaka Shodita Haratala. The study aims to provide insights into the comparative efficacy and analytical aspects of these formulations for enhanced therapeutic outcomes.
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Basavarajeeyam is a Sreshta Sangraha grantha (Compiled book ), written by Neelkanta kotturu Basavaraja Virachita. It contains 25 Prakaranas, First 24 Chapters related to Rogas& 25th to Rasadravyas.
8 Surprising Reasons To Meditate 40 Minutes A Day That Can Change Your Life.pptxHolistified Wellness
We’re talking about Vedic Meditation, a form of meditation that has been around for at least 5,000 years. Back then, the people who lived in the Indus Valley, now known as India and Pakistan, practised meditation as a fundamental part of daily life. This knowledge that has given us yoga and Ayurveda, was known as Veda, hence the name Vedic. And though there are some written records, the practice has been passed down verbally from generation to generation.
Cell Therapy Expansion and Challenges in Autoimmune DiseaseHealth Advances
There is increasing confidence that cell therapies will soon play a role in the treatment of autoimmune disorders, but the extent of this impact remains to be seen. Early readouts on autologous CAR-Ts in lupus are encouraging, but manufacturing and cost limitations are likely to restrict access to highly refractory patients. Allogeneic CAR-Ts have the potential to broaden access to earlier lines of treatment due to their inherent cost benefits, however they will need to demonstrate comparable or improved efficacy to established modalities.
In addition to infrastructure and capacity constraints, CAR-Ts face a very different risk-benefit dynamic in autoimmune compared to oncology, highlighting the need for tolerable therapies with low adverse event risk. CAR-NK and Treg-based therapies are also being developed in certain autoimmune disorders and may demonstrate favorable safety profiles. Several novel non-cell therapies such as bispecific antibodies, nanobodies, and RNAi drugs, may also offer future alternative competitive solutions with variable value propositions.
Widespread adoption of cell therapies will not only require strong efficacy and safety data, but also adapted pricing and access strategies. At oncology-based price points, CAR-Ts are unlikely to achieve broad market access in autoimmune disorders, with eligible patient populations that are potentially orders of magnitude greater than the number of currently addressable cancer patients. Developers have made strides towards reducing cell therapy COGS while improving manufacturing efficiency, but payors will inevitably restrict access until more sustainable pricing is achieved.
Despite these headwinds, industry leaders and investors remain confident that cell therapies are poised to address significant unmet need in patients suffering from autoimmune disorders. However, the extent of this impact on the treatment landscape remains to be seen, as the industry rapidly approaches an inflection point.
TEST BANK For Basic and Clinical Pharmacology, 14th Edition by Bertram G. Kat...rightmanforbloodline
TEST BANK For Basic and Clinical Pharmacology, 14th Edition by Bertram G. Katzung, Verified Chapters 1 - 66, Complete Newest Version.
TEST BANK For Basic and Clinical Pharmacology, 14th Edition by Bertram G. Katzung, Verified Chapters 1 - 66, Complete Newest Version.
TEST BANK For Basic and Clinical Pharmacology, 14th Edition by Bertram G. Katzung, Verified Chapters 1 - 66, Complete Newest Version.
TEST BANK For Basic and Clinical Pharmacology, 14th Edition by Bertram G. Katzung, Verified Chapters 1 - 66, Complete Newest Version.
2. 2
Company Highlights
Ocular Therapeutics Represents a $10B+ Global and Growing Market
GB-102: Dual VEGFR/PDGFR tyrosine kinase inhibitor dosed twice per year
(potential for superiority to Eylea® and reduced injection frequency)
• On track for IND in 2017 for wet AMD indication (pre-IND meeting with FDA completed)
Graybug Vision’s Patented Technology Solves Key Challenges for
Sustained Ocular Delivery
• Injectable with minimal side effects & no visual disturbance
• Tunable approach – release rate and duration up to 1 year
• No inflammation, no toxicity, 6 month in vivo release
Technology Enables Broad Portfolio of Ocular Products
• Age-related macular degeneration (wet) lead program
• Glaucoma programs with 6 month subconjunctival dosing regimen
• Pipeline development to leverage delivery and prodrug platforms
Experienced and Knowledgeable Team
• Ophthalmology & Drug Delivery Experts
3. 3
An Experienced Management Team
Jeffrey Cleland, PhD
President & CEO
Board Member
Former CEO, Co-Founder, Versartis
>20 Years of Drug Development Experience
Team Leader Through Launch of Only FDA
Approved Long-Acting hGH Product; Early
development of Lucentis
Charles Semba, MD
Chief Medical Officer
Former CMO at Forsight VISION 5 and SARcode.
VP, Shire. Led clinical development of Lucentis at
Genentech. >15 Years of Drug Development
Expertise
Ward Peterson, PhD
SVP, Preclinical
Development
Former SVP, Inspire. Research scientist at
Regeneron. > 20 Years of Drug Development
Expertise
OPHTHALMOLOGY
& INTRAOCULAR
THERAPY
LONG ACTING
PRODUCTS
Somavaratan
4. 4
GB-102 (Sunitinib):
Dual VEGFR/PDGFR tyrosine kinase inhibitor (TKI)
Sunitinib is the active ingredient in GB-102 and SUTENT®
• Oral dosing of SUTENT leads to higher ocular levels than GB-102 without ocular
toxicity
• Oral dosing of SUTENT is effective in mouse CNV model and a patient treated for
RCC with anti-VEGF refractory wet AMD (visual acuity improved)
• Oral doses of SUTENT required for ocular disease leads to systemic adverse events
GB-102 provides sustained intravitreal delivery minimizing systemic exposure
• A twice per year (or longer) dose interval may increase compliance and sustained
levels may increase durability of response
• Targeting VEGF & PDGF at the receptor level may increase response rates
• Opportunity for superiority compared to Eylea® (see Fovista® results) from a
single agent
GB-102 (Sunitinib) may become “Best in Class” Therapy to treat wet AMD
5. 5
Injectable High Capacity Reservoir and
Localization of Microparticles
Biodegradability
Biocompatibility
Bioabsorbability
Polymer
Modified to
Reduce
Inflammation
ENCAPSULATED DRUG INTRAVITREAL INJECTION
WITH SMALL GAUGE
NEEDLE
Microparticle
Localization
Designed to Aggregate
and Remain Outside
Visual Axis
FUNDUS PHOTOS, DAY 7
6. 6
Long Term Efficacy of Single Dose of GB-102:
Potential for Superiority over Aflibercept
GB-102 Dose Groups
0.5 mg GB-102 (0.05 mg Sunitinib)
1 mg GB-102 (0.1 mg Sunitinib)
3 mg GB-102 (0.3 mg Sunitinib)
3 months
3 wk
3 wk
Aflibercept (Eylea®)
0.7 mg same day as laser
Fluorescein
Angiograms
(CNV area)
LaserDosing
GB-102 Dose 0.5 mg 1.0 mg 3 mg
Sunitinib Dose 0.05 mg 0.10 mg 0.30 mg Aflibercept Placebo
p < 0.01
Rabbit CNV
Model
Poster Presentation, PO268, Sunday, Oct 16, 12:30 pm
• All three dose levels more effective
than aflibercept
• Benefit of targeting receptors
• Once receptors blocked, increased
dose does not increase response
• Additional dose/duration studies
ongoing
en
7. 7
Single Dose of GB-102 Every 6 months
IVT Injection in Pigmented Rabbits
10 mg GB-102 (1 mg sunitinib)
50 µL
Data Supports Twice Per Year or Less Frequent Dosing
With Comparable Safety to Current Products
(Selected tissues)
PK/PD Modeling:
Levels Achieved at 6 mo Match Effective Doses
Effective for
Inhibition of CNV
10 mg GB-102 (1 mg sunitinib)
8. 8
Challenges with Current Glaucoma Drugs
• Current approved glaucoma products require daily or BID topical dosing
• Patients are non-compliant with therapy (72% in controlled setting; 50%
or less in clinical practice; Quigley et al)
• Neuroprotective agent desirable but clinical trials are long and expensive
(none approved to date) – dual acting agent (IOP+) allows development
• Programs under evaluation (all NCEs) – all 6 month subconjunctival
depot formulations
– All parent drugs are approved drugs
– Single agent IOP lowering prodrug
– Dual agent (two MOAs) IOP lowering (single prodrug)
– IOP lowering and neuroprotection (single prodrug)
9. 9
Preclinical POC on Glaucoma Programs 2H 2017
Key Milestones for Value Creation
Initiate Phase 1/2 Trial with GB-102
(patients on anti-VEGF with nAMD)
1H 2017
GB-102 Phase 1/2
Prelim Safety & Efficacy 1H 2018 nAMD
Glaucoma
Program
Glaucoma Product Phase 1/2
Prelim Safety & Efficacy 1H 2019
Glaucoma Product IND &
Initiate Phase 1/2 Trial 1H 2018
GB-102 Phase 1/2 (US)
Top Line Safety & Efficacy 2H 2019
10. 10
Company Highlights
Ocular Therapeutics Represents a $10B+ Global and Growing Market
GB-102: Dual VEGFR/PDGFR tyrosine kinase inhibitor dosed twice per year
(potential for superiority to Eylea® and reduced injection frequency)
• On track for IND in 2017 for wet AMD indication (pre-IND meeting with FDA completed)
Graybug Vision’s Patented Technology Solves Key Challenges for
Sustained Ocular Delivery
• Injectable with minimal side effects & no visual disturbance
• Tunable approach – release rate and duration up to 1 year
• No inflammation, no toxicity, 6 month in vivo release
Technology Enables Broad Portfolio of Ocular Products
• Age-related macular degeneration (wet) lead program
• Glaucoma programs with 6 month subconjunctival dosing regimen
• Pipeline development to leverage delivery and prodrug platforms
Experienced and Knowledgeable Team
• Ophthalmology & Drug Delivery Experts