Gemvax & Kael Co. Ltd. has identified peptides reported to be useful for the treatment of age-related macular degeneration (AMD), cerebral amyloid angiopathy and Alzheimer’s disease.
Pulsesight Therapeutics SAS has submitted a clinical trial authorization (CTA) to the French authority ANSM seeking to conduct a first-in-human phase I trial of PST-611 for dry age-related macular degeneration (AMD)/geographic atrophy (GA).
Outlook Therapeutics Inc. is forging onward with plans to resubmit the BLA for ONS-5010, an ophthalmic version of Avastin (bevacizumab, Roche AG), after a missed endpoint in phase III with the VEGF binder for wet age-related macular degeneration (AMD).
The U.S. FDA issued a complete response letter Nov. 15 for Izervay’s (avacincaptad pegol intravitreal solution, ACP) supplemental NDA, which sought to include positive two-year data for the Astellas Pharma Inc. therapy, previously approved for use in a treatment for geographic atrophy secondary to age-related macular degeneration.
Ring Therapeutics Inc. has joined forces with Singapore’s Agency for Science, Technology, and Research and with the Singapore Eye Research Institute to advance the first new class of viral vectors in more than 50 years, Ring CEO Tuyen Ong told BioWorld.
The nearer-looming threat of a biosimilar from Amgen Inc. to heavyweight Regeneron Pharmaceuticals Inc.’s age-related macular degeneration (AMD) VEGF therapy, Eylea (aflibercept), along with other issues, pressured shares of the latter (NASDAQ:REGN) since reporting third-quarter earnings Oct 31. But Wall Street pundits are not altogether aligned on how serious the scenario might be. After the earnings update, Regeneron’s stock fell 12%, from $925 to $819.96, and closed Nov. 1 at $843.60, up $5.40.
Astellas Pharma Inc. has withdrawn its marketing authorization application from the EMA for its avacincaptad pegol intravitreal solution for the treatment of geographic atrophy secondary to age-related macular degeneration. “The company's decision to withdraw its application followed interactions” with the EMA’s Committee for Medicinal Products for Human Use, an Astellas spokesperson told BioWorld.
Innovec Pharmaceutical Technology Co. Ltd. (Innovec Biotherapeutics) has received FDA clearance for its IND application for IVB-103, an AAV-based gene therapy for neovascular age-related macular degeneration (AMD).
As the hunt goes on for a better treatment in wet age-related macular degeneration (AMD), landmark analyses of two batches of phase II gene therapy data billed as positive were disclosed during the American Society of Retina Specialists annual meeting in Stockholm, where 4D Molecular Therapeutics Inc. and Adverum Biotechnologies Inc. offered findings.
Nexthera Co. Ltd. has submitted an IND application to the FDA seeking to conduct a phase I/IIa trial with NT-101, a noninvasive eye drop treatment for wet age-related macular degeneration (AMD).
