Our next panel, “Take a Look at What’s in Store for Wet AMD & Related Diabetic Eye Diseases,” featured Dr. Thomas Ciulla, MD, MBA, FASRS, CMO & CDO of Clearside Biomedical, Inc., Nancy Lurker, President, CEO & Board Director of EyePoint Pharmaceuticals, Mina Sooch, President & CEO of Ocuphire Pharma, Kerrie Brady, President & CEO of OcuTerra Therapeutics, C. Russ Trenary III, President & CEO of Outlook Therapeutics, Inc., and Dr. Raj Agrawal, M.D., VP & Head of Ophthalmological Clinical Development at Rezolute, Inc. The panel was moderated by Cantor’s Jennifer Kim.
• Rezolute is developing RZ402, a plasma kallikrein inhibitor (PKI), as a potential oral therapy for DME. The company plans to initiate a Phase 2 proof-of-concept study by YE ’22, with data by YE ’23
• Clearside is developing its own pipeline of small molecule product candidates for administration via its SCS (suprachoroidal space) Microinjector. It strategically partners its SCS delivery platform with companies utilizing other ophthalmic therapeutic innovations, including one commercialized product, Xipere
• Ocuphire plans to report top-line results from the Phase 2b ZETA-1 trial for novel oral therapy, APX3330 (Ref-1 inhibitor), for diabetic retinopathy (DR) and diabetic macular edema (DME) in early 2023. The company recently entered into a global license agreement with FamyGen Life Sciences/Viatris for the development/commercialization of Nyxol, a separate candidate targeting multiple front-of-the-eye indications
• Outlook has a BLA filing acceptance for what could serve as the first FDA-approved ophthalmic formulation of bevacizumab (ONS-5010/LYTENAVA) for wet AMD, with a PDUFA date of 8/29/2023
• Eyepoint is developing EYP-1901 as a potential “Treat-t0-Maintain” therapy in wet age-related macular degeneration (wet AMD), with Phase 2 DAVIO 2 data guided to 4Q23. The company also has an ongoing Phase 2 PAVIA trial in non-proliferative diabetic retinopathy (NPDR), which could represent an additional blockbuster category
• OcuTerra is focused on execution with its ongoing Phase 2 DR:EAM trial for OTT166 eye drops (RGD integrin inhibitor) in patients with DR, as a potential early, non-invasive intervention option
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