Presentation from OIS@ASCRS 2016
Amar Sawhney, PhD, President, CEO & Chairman
Video Presentation:
https://www.youtube.com/watch?v=nGQzo6czij0&list=PL1dmdBNnPTZJBhQxPOp0vdNg3s3wtN2yw&index=31
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.
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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Presentation from OIS@ASCRS 2016
Tom Mitro, President & COO
Video Presentation:
https://www.youtube.com/watch?v=rjLnP6lmRWU&list=PL1dmdBNnPTZJBhQxPOp0vdNg3s3wtN2yw&index=29
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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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.
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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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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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.
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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Presentation from OIS@ASCRS 2016
Tom Mitro, President & COO
Video Presentation:
https://www.youtube.com/watch?v=rjLnP6lmRWU&list=PL1dmdBNnPTZJBhQxPOp0vdNg3s3wtN2yw&index=29
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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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.
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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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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Presentation from OIS@ASCRS 2016
James Brandt, MD, Principal Investigator
Video Presentation:
https://www.youtube.com/watch?v=jvIozhPMSQ8&list=PL1dmdBNnPTZJBhQxPOp0vdNg3s3wtN2yw&index=30
Posterior Segment Company Showcase - AGTCHealthegy
Posterior Segment Company Showcase - AGTC at OIS@AAO 2016.
Presenter:
Sue Washer, President & CEO
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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
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.
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
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 - Alimera SciencesHealthegy
Posterior Segment Company Showcase - Alimera Sciences at OIS@AAO 2016.
Presenter:
Dan Myers, 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 - Clearside BiomedicalHealthegy
Posterior Segment Company Showcase - Clearside Biomedical at OIS@AAO 2016.
Presenter:
Daniel White, 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.
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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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-
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 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.
Anterior Segment Company Showcase - TearScienceHealthegy
Anterior Segment Company Showcase - TearScience at OIS@AAO 2016.
Presenter:
Joseph Boorady, President & CEO
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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.
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.
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.
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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Presentation from OIS@ASCRS 2016
James Brandt, MD, Principal Investigator
Video Presentation:
https://www.youtube.com/watch?v=jvIozhPMSQ8&list=PL1dmdBNnPTZJBhQxPOp0vdNg3s3wtN2yw&index=30
Posterior Segment Company Showcase - AGTCHealthegy
Posterior Segment Company Showcase - AGTC at OIS@AAO 2016.
Presenter:
Sue Washer, President & CEO
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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
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.
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
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 - Alimera SciencesHealthegy
Posterior Segment Company Showcase - Alimera Sciences at OIS@AAO 2016.
Presenter:
Dan Myers, 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 - Clearside BiomedicalHealthegy
Posterior Segment Company Showcase - Clearside Biomedical at OIS@AAO 2016.
Presenter:
Daniel White, 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.
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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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-
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 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.
Anterior Segment Company Showcase - TearScienceHealthegy
Anterior Segment Company Showcase - TearScience at OIS@AAO 2016.
Presenter:
Joseph Boorady, President & CEO
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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.
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.
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.
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 - 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
Posterior Segment Company Showcase - Notal visionHealthegy
Posterior Segment Company Showcase - Notal vision at OIS@AAO 2016.
Presenter:
Quinton Oswald, CEO
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Posterior Segment Company Showcase - AerpioHealthegy
Posterior Segment Company Showcase - Aerpio at OIS@AAO 2016.
Presenter:
Joseph Gardner, 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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ClearSightTM is an intraocular lens (IOL) platform designed to eliminate posterior capsule opacification (PCO) using SharkletTM technology. It has multiple issued patents and shown strong results in vivo, reducing cell migration by 80% and treatable PCO by 100% in studies. The ClearSightTM IOL addresses a significant problem in a large market by being the first IOL designed to eliminate PCO.
This document discusses microinvasive glaucoma surgery (MIGS) and the growing market potential for MIGS devices. It provides an overview of current glaucoma treatment options and their limitations. The author estimates that there are currently around 250,000 glaucoma surgeries performed annually in the US, but that the potential market for MIGS devices could be much larger given the number of glaucoma patients on multiple medications who could be candidates for MIGS. Financial data is presented for one company demonstrating the growth in the MIGS market.
The document discusses sustained release dosage forms. It begins by introducing drug delivery systems and how newer technologies have led to various techniques for delivering drugs. It then discusses the ideal properties of a drug delivery system, including maintaining therapeutic drug levels over an extended period of time and targeting the site of action. The document goes on to define and compare different types of modified release dosage forms such as sustained release, controlled release, and timed/delayed release forms. It provides details on the advantages and limitations of sustained release dosage forms.
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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Controlled Release Drug Delivery Systems - Types, Methods and ApplicationsSuraj Choudhary
This document discusses factors affecting the design of controlled release drug delivery systems (CRDDS). It outlines several key considerations for CRDDS design including selection of the drug candidate, medical and biological rationale, and physicochemical properties. It also discusses important physicochemical factors such as solubility, partition coefficient, molecular size and diffusivity, dose size, complexation, ionization constant, drug stability, and protein binding that influence CRDDS design. Finally, it briefly describes dissolution-controlled and diffusion-controlled release approaches for developing CRDDS.
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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- PTX has a deep clinical pipeline with 3 ongoing or planned clinical trials, including Phase Ib/II trials of PTX-200 in breast cancer and ovarian cancer, and a planned Phase Ib trial of PTX-100 in AML.
- PTX-200 and PTX-100 are novel cancer drugs targeting the Akt and Ras pathways that have potential to overcome chemotherapy resistance.
- The clinical trials are being conducted at prestigious cancer centers in the US including Moffitt Cancer Center and Albert Einstein College of Medicine.
Interpace Diagnostics provides molecular diagnostic tests and pathology services to evaluate cancer risk. The presentation discusses:
1) Interpace's product portfolio including tests that risk-stratify pancreatic cysts, Barrett's esophagus, and thyroid nodules.
2) Clinical evidence and guidelines supporting their tests, and growth in adoption and coverage by payers.
3) Financial highlights including recent funding raises, revenue growth, and progress reducing costs.
4) Drivers for continued growth including expanding sales force and strategic partnerships.
Exelixis reported financial results for Q1 2014 and provided updates on its clinical trials and product pipeline. Key highlights include:
- Net revenue of $4.9M from sales of COMETRIQ for medullary thyroid cancer.
- Two phase 3 trials of cabozantinib in castration-resistant prostate cancer (COMET-1 and COMET-2) continue as planned and are expected to report top-line data in 2014.
- Phase 3 trials of cabozantinib are ongoing or planned in renal cell carcinoma (METEOR), hepatocellular carcinoma (CELESTIAL), and medullary thyroid cancer (EXAM). Top-line data from
Opexa Therapeutics is developing personalized T-cell immunotherapies for autoimmune diseases. Their lead candidate, Tcelna, is in Phase 2b clinical trials for secondary progressive multiple sclerosis and has shown signs of stabilizing disease progression in previous trials. Opexa has an option agreement with Merck Serono for the development and commercialization of Tcelna in multiple sclerosis. Recent milestones include completing enrollment in the Tcelna Phase 2b trial for SPMS and receiving a $3 million payment from Merck Serono. Opexa is also developing OPX-212 for neuromyelitis optica and expects to file an IND by the end of 2015.
This document provides non-GAAP financial information and reconciliations for Edwards Lifesciences Corporation. It defines non-GAAP measures used by the company such as underlying sales, adjusted net income, and adjusted EPS, which exclude items like currency fluctuations, acquisitions, divestitures, and special charges. It also notes management considers free cash flow an important liquidity measure and provides the company's definition. In addition, the document gives examples of items excluded from non-GAAP measures for specific periods to reconcile to GAAP reporting, such as intellectual property litigation expenses.
- The document presents information on Praluent (alirocumab), the first PCSK9 inhibitor therapy approved in the US for treatment of adults with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease who require additional lowering of LDL cholesterol.
- Praluent demonstrated robust and durable LDL-C reduction of over 52 weeks in clinical trials in patients on maximally tolerated statin therapy, with 57-83% of patients achieving sufficient LDL-C reduction with the 75 mg starting dose.
- The Committee for Medicinal Products for Human Use adopted a positive opinion for Praluent in Europe, and approval is expected in late September 2015. The OD
Glaukos investor presentation q2 2016 for website 08032016glaukos
Glaukos Corporation is a medical technology company transforming glaucoma treatment. Their solution portfolio includes micro-scale injectable therapies to restore and enhance aqueous outflow including the iStent, iStent Inject, and iStent Supra. Clinical trials show the iStent reduces intraocular pressure and medication use when used with cataract surgery or as a standalone procedure. Glaukos has established global commercial operations and seized the first mover opportunity in key markets since US FDA approval of the iStent.
The document summarizes Bellus Health's annual meeting presentation from May 15, 2013. It discusses Bellus' product pipeline, including KIACTA for AA amyloidosis, which has completed a positive Phase II/III trial. Bellus' partner Auven Therapeutics is funding the Phase III confirmatory study of KIACTA. Bellus also discusses its memory supplement VIVIMIND and its Alzheimer's drug BLU8499. The presentation outlines Bellus' business model, partnerships, financial position, and future milestones including completing enrollment in the KIACTA Phase III study and initiating BLU8499's Phase IIa trial.
Opexa Therapeutics August 2015 OPXA Corporate PresentationOpexaTherapeutics
Opexa Therapeutics presented information on their precision immunotherapy platform and key programs. Their lead candidate, Tcelna, is in Phase 2b clinical trials for secondary progressive multiple sclerosis and has shown signs of stabilizing disease progression. Tcelna works by reducing myelin reactive T-cells that damage the myelin sheath. Opexa has an option agreement with Merck Serono for the development and commercialization of Tcelna in multiple sclerosis. Additionally, Opexa is developing OPX-212 for neuromyelitis optica, an orphan indication with no approved therapies.
NeoStem, Inc. (“NeoStem” or the “Company”), a biopharmaceutical company, is capitalizing on the paradigm shift occurring in medicine by engaging in the development and manufacture of cellular therapies for oncology, immunology, and regenerative medicines in the United States. The Company anticipates that cell therapy will play a significant role in the fight against chronic disease and in lessening the economic burden that these diseases pose to modern society.
Prescient is preparing to commence a Phase 1b/2 clinical trial of PTX-200 in acute myeloid leukemia (AML) at prominent cancer research centers in the United States. PTX-200 is a novel inhibitor of the Akt signaling pathway that has shown promise in overcoming chemotherapy resistance and inducing cancer cell death with fewer toxic side effects than other Akt inhibitors. If successful, the upcoming AML trial could increase interest in Prescient and validate PTX-200 as an improved treatment for this disease with high unmet medical need. Prescient has additional clinical-stage oncology programs in breast cancer, ovarian cancer, and multiple myeloma across its pipeline.
Sutro Biopharma is conducting a Phase 1 clinical trial of STRO-002, an antibody-drug conjugate (ADC) targeting folate receptor alpha (FolRα), in patients with advanced platinum-resistant or refractory epithelial ovarian cancer, fallopian tube or primary peritoneal cancers. Interim data from the trial will be presented at the AACR virtual conference on April 27th. STRO-002 was designed using Sutro's proprietary protein engineering platform, XpressCF, to have improved stability and a widened therapeutic index compared to other FolRα-targeting ADCs. Preclinical studies demonstrated STRO-002's enhanced potency and specificity versus benchmarks. The trial will evaluate
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Can-Fite BioPharma Ltd. (NYSE American: CANF) is an advanced clinical stage drug development company with a platform technology that addresses multi-billion-dollar markets in the treatment of autoimmune inflammatory diseases including Psoriasis, and liver diseases including advanced liver cancer and NASH. Can-Fite’s drugs have an excellent safety profile with experience in over 1,000 patients. Can-Fite’s intellectual property portfolio consists of 13 patent families issued and pending. Piclidenoson and Namodenoson have been out-licensed in select territories with approximately $18 million received to date. Piclidenoson received approval for COVID-19 clinical trial in Israel in April 2020 and is expected to file its IND in the US in the near-term.
American Noble Gas is an oil and gas exploration, development, and production company with a history of operations in Texas, Kansas, Oklahoma, and the Rocky Mountain region of the US. The Company is currently exploring and developing natural gas, helium, and other noble gases and brine minerals contained in the Hugoton Gas Field, a prolific natural gas and helium gas field spanning the states of Kansas, Oklahoma, and Texas, through a 40% participation in a farmout agreement that covers drilling and completion of up to 50 wells. American Noble Gas also owns 60.7143% of GMDOC, LLC, LLC which acquired certain oil and gas leases covering approximately 10,000 acres located in Southern Kansas near the Oklahoma border. The GMDOC leases currently produce approximately 100 barrels of oil and 1.2 million cubic feet of natural gas per day on a gross basis. The Company also owns mineral rights to approximately 11,000 acres in the Otis/Albert Field located on the Kansas Central Uplift.
Unicycive Therapeutics (UNCY) is a developer of residential communities in Northern Baja California with projects are targeted at buyers and investors of primary, vacation, and/or retirement homes. The Company’s projects in Northern Baja – a popular tourism and retirement destination – are strategically located within driving distance of Southern California and are supported by the region’s attractive demographics, large pent-up demand, and persistent housing shortages. With a goal of delivering sustainable and socially responsible solutions, the Company leverages advanced property and construction technologies to provide a seamless and efficient platform that enhances the customer sales experience. A newly added mortgage division, providing previously unattainable financing options to US buyers, is expected to drive accelerate sales growth across UNCY’s projects.
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- Growth of Sanofi's immunology franchise including Dupixent is discussed as an emerging driver of specialty care sales.
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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.
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Masters of the Industry at OIS@AAO 2016.
Moderated By:
Jim Mazzo, Global President Ophthalmic Devices - Carl Zeiss Meditec
Participants:
Flemming Ornskov, MD, CEO - Shire
Mike Ball, CEO - Alcon
Ashley McEvoy, Company Group Chairman - Johnson & Johnson Vision Care
William J. Link, PhD, Managing Director - Versant Ventures
Ludwin Monz, PhD, President & CEO - Carl Zeiss Meditec
William Meury, Chief Commercial Officer - Allergan
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For more ophthalmology innovation
Visit us at www.ois.net
Michigan HealthTech Market Map 2024. Includes 7 categories: Policy Makers, Academic Innovation Centers, Digital Health Providers, Healthcare Providers, Payers / Insurance, Device Companies, Life Science Companies, Innovation Accelerators. Developed by the Michigan-Israel Business Accelerator
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1. Amar Sawhney, Ph.D., CEO
OIS@ASCRS
New Orleans
May 5, 2016
1
Transforming Ophthalmic Care
with Sustained Therapies
2. Forward-Looking Statements
2
This presentation contains forward-looking statements about future expectations, plans and prospects for the
Company, including statements about the development and regulatory status of the Company’s product
candidates, such as the Company’s expectations and plans regarding regulatory submissions for and the timing
and conduct of clinical trials of DEXTENZA for post-surgical inflammation and pain, DEXTENZA for allergic
conjunctivitis, DEXTENZA for dry eye disease and OTX T-P for glaucoma and ocular hypertension, the ongoing
development of the Company’s sustained released hydrogel depot technology, pre-commercial activities, the
potential commercialization of DEXTENZA, the potential utility of any of the Company’s product candidates, the
advancement of the Company's other product candidates and earlier stage pipeline, future sales of ReSure®
Sealant, the sufficiency of the Company’s cash resources and other statements containing the words
"anticipate," "believe," "estimate," "expect," "intend", "goal," "may," "might," "plan," "predict," "project," "target,"
"potential," "will," "would," "could," "should," "continue," and similar expressions, constitute forward-looking
statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ
materially from those indicated by such forward-looking statements as a result of various important factors.
Such forward-looking statements involve substantial risks and uncertainties that could cause Ocular
Therapeutix’s clinical development programs, future results, performance or achievements to differ significantly
from those expressed or implied by the forward-looking statements. Such risks and uncertainties include,
among others, those related to the timing and costs involved in commercializing ReSure® Sealant and
DEXTENZA, the initiation and conduct of clinical trials, availability of data from clinical trials and expectations for
regulatory submissions and approvals, the Company’s scientific approach and general development progress,
the availability or commercial potential of the Company’s product candidates, the sufficiency of cash resources
and need for additional financing or other actions and other factors discussed in the “Risk Factors” section of
the Company’s filings with the Securities and Exchange Commission, including the Company’s most recent
Annual Report on Form 10-K. In addition, the forward-looking statements included in this presentation represent
the Company’s views as of the date of this presentation. The Company anticipates that subsequent events and
developments will cause the Company’s views to change. However, while the Company may elect to update
these forward-looking statements at some point in the future, the Company specifically disclaims any obligation
to do so. These forward-looking statements should not be relied upon as representing the Company’s views as
of any date subsequent to the date of this presentation.
3. Drug-eluting intracanalicular depots and intravitreal injections are investigational new drugs and not commercially available in the United States or other
geographies.
Posterior
Segment
Sustained
Release
Injections
Anterior Segment
Sustained
Release
Therapies
Hydrogel Sealant
Addressing Diseases in the
Anterior and Posterior Segment
Transforming Ophthalmic Care with
Sustained Therapies
3
4. Compliance is Key
4
Burden of Daily Eye Drops In an observational study,
92.6% of post-cataract patients
showed improper
administration technique with
steroid drops:
• Missing eye
• Instilling incorrect amount
• Contaminating bottle tip
• Failing to wash hands
An JA, Kasner O, Samek DA, Levesque V. Evaluation of
eyedrop administration by inexperienced patients after cataract
surgery. J Cataract Refract Surg, 2014; 40:1857-1861
Real World Outcomes Are Not Optimal
5. Platform Value Proposition
5
COMPLIANCE
PHYSICIAN CONTROL
PRESERVATIVE-FREE
Ocular Therapeutix
sustained delivery
Understanding the Opportunity for DEXTENZA™ in Ophthalmology Practices Working Insights, n=42 ophthalmologists IDIs. Krog and Partners,
March, 2016. Strategy & Message Platform Validation Research, n=50 U.S. ophthalmologists, OptiBrand Rx LLC, 2015.
6. 6
1. IMS data, March 2016
2. Roche Finance Report 2015, page 11 http://www.roche.com/fb15e.pdf; Regeneron; http://www.fiercepharma.com/story/after-big-2015-regeneron-predicts-slowing-
2016-sales-launch-superstar-eylea/2016-02-09;
Targeting Markets in the U.S. Currently Totaling $11Bn1,2
US Sales ($Bn)
Market Opportunities
OTX-TP
Glaucoma
$ 2.7
Allergy
$ 1.0
Dry eye
$ 1.6
Pain & Inflammation
(Anti-Inflammatories)
$ 1.5
Inflammator
y
Conditions
$ 4.1
OTX-IVT
Anti-VEGF
$ 4.2
10. Market Research Outcomes
10
Standard of Care
DEXTENZA
79%
Other
21%
79% of Ophthalmologists stated that DEXTENZA™
could become new standard of care
Understanding the Opportunity for DEXTENZA™ in Ophthalmology Practices Working Insights, n=42 ophthalmologists IDIs. Krog and Partners, March,
12. Sustained Release Travoprost (OTX-TP)
12
Product Profile:
• Sustained release depot
• Designed to replace daily therapy
• Preservative-free
• Product can be monitored by patient
Initial Planned Indication:
• Intraocular pressure reduction for glaucoma and ocular hypertension
Delivery Method:
• Non-invasive
• Physician-administered: inserted into canaliculus
• Provides sustained delivery for up to 90 days
13. • Multiple Phase 2 trials have demonstrated clinically meaningful
5+ mm/Hg of IOP lowering with a single placement out to 2-3
months
• FDA discussions for Phase 3 plans indicate:
– Placebo comparator acceptable
– Need to demonstrate statistical superiority to placebo and
clinically meaningful reduction of IOP
– No timolol comparator or validation arm required, no eye drops
required (placebo or active)
– Two planned trials: ~550 subjects/study; 100+ to be followed
out to one year for safety in one trial
• Expect to begin Phase 3 clinical studies in 2H 2016
OTX-TP Progress and Plans
13
15. Posterior Segment Programs
15
Protein
Therapeutics
• Demonstrated:
– Protein stability
– Tolerability
– Release profile
• Seek partnership for
anti-VEGF drug
Small Molecule
Drugs
Tyrosine Kinase
Inhibitors (TKIs)
• Pursuing internal
development
• Initial PK/PD and
tolerability demonstrated
Injectable depot
• 6 months sustained release
• Fine needle injection
• No interference with vision
• Biocompatible
• Absorbable
16. Rabbit PD Screening Model
Fluorescein Angiography (FA) Scores at 2, 4, 6, 9, 12 weeks
Bevacizumab-loaded fiber showed inhibition up to 12 weeks
vs. < 6 weeks from single human Avastin dose (1.25mg)
Empty Depot Control
Avastin Pre-treatment
Inhibition: Leakage score = 0
No Inhibition: Leakage: score = 4
Fluorescein leaking from vessels
Representative FA Images
Bevacizumab-loaded fiber showed continued inhibition up to 12 weeks
Sustained Pharmacodynamic Activity