Putting into jeopardy what was on track to be the first approved therapy in Europe for geographic atrophy (GA), an advanced form of age-related macular degeneration that causes blindness, Apellis Pharmaceuticals Inc. learned of a negative trend vote by the EMA’s Committee for Medicinal Products for Human Use (CHMP) on its MAA for intravitreal pegcetacoplan.
Positive top-line data from Eyepoint Pharmaceuticals Inc.’s phase II study of EYP-1901 and the selective tyrosine kinase inhibitor vorolanib for treating wet age-related macular degeneration (AMD) is challenging Regeneron Pharmaceuticals Inc.’s recently approved Eylea (aflibercept).
A Character Biosciences Inc. patent describes polypeptides acting as low-density lipoprotein receptor (LDLR) ligands and reported to be useful for the treatment of age-related macular degeneration (AMD).
Inmed Pharmaceuticals Inc. has identified a lead cannabinol (CBN) analogue candidate, INM-089, to advance into additional in vivo studies for age-related macular degeneration (AMD).
As expected, Aldeyra Therapeutics Inc. received a complete response letter (CRL) from the U.S. FDA regarding its NDA for reproxalap in dry eye disease, with the agency requiring “at least one” additional study to prove efficacy of the reactive aldehyde species, or RASP, modulator.
Yale University has identified compounds reported to be useful for the treatment of dry age-related macular degeneration (AMD), Fuchs endothelial corneal dystrophy, cataract, glaucoma and keratoconus.
Abionyx Pharma SA has released new preclinical efficacy results with CER-001 after a single intraocular administration in a uveitis model with severe inflammation.
Oxurion NV, which had spent much of 2023 scraping together funding in hopes of a positive readout for its bicyclic peptide, THR-149, in diabetic macular edema (DME), now faces a bankruptcy filing after the drug failed to best established anti-VEGF therapy aflibercept (Regeneron Pharmaceuticals Inc.) in improving vision in part B of the phase II Kalahari study.
Researchers from the University of Lausanne and affiliated organizations recently presented data from a study that aimed to identify novel candidate causative genes of visual impairment.
Inflammasome Therapeutics Inc. has received FDA clearance to begin a phase I/II trial of the company’s inflammasome inhibitor for the treatment of geographic atrophy, the most severe form of dry age-related macular degeneration. This is the first clinical trial of an inflammasome inhibitor to treat geographic atrophy. The company’s sustained-release implant contains the first of a new class of inflammasome inhibitor drugs, Kamuvudines, developed by the company and designed to halt the multiple processes that cause geographic atrophy.
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