Receiving a third complete response letter (CRL) from the U.S. FDA for its bevacizumab formulation, ONS-5010, to treat wet age-related macular degeneration, Outlook Therapeutics Inc. watched its stock (NASDAQ:OTLK) plummet nearly 62% to a 52-week low of 60 cents on Jan. 2.
Guangzhou Runer Ophthalmic Biotechnology Co. Ltd. has identified complement factor B (CFB) inhibitors reported to be useful for the treatment of age-related macular degeneration, asthma, atherosclerosis, Crohn’s disease, glomerular disorders, hemolytic uremic syndrome, neurological disorders and diabetic retinopathy, among others.
Viatris Inc. has announced FDA clearance of its IND application for MR-146, an Enriched Tear Film (ETF) AAV gene therapy candidate for the treatment of neurotrophic keratopathy. The company plans to initiate a phase I/II trial in patients with neurotrophic keratopathy in the first half of next year.
Two large deals and an acquisition, totaling about $4.64 billion in all, are helping wrap up what’s turning out to be a strong year. Through the first 11 months of 2025, biopharma dealmaking was robust with a collective value of $261.14 billion, the highest January through November total of the past seven years and well above 2024’s $201.35 billion. These three December deals helped revive the surge in dealmaking that had cooled in November.
Attention has turned to the regulatory path worldwide after Belite Bio Inc. unveiled positive top-line data from the phase III Dragon study with oral, daily tinlarebant in Stargardt disease type 1, the most common form of the rare affliction.
Coave Therapeutics SA has nominated a lead gene therapy program, CoTx-101, for the treatment of retinal vascular diseases, such as wet age-related macular degeneration and diabetic macular edema.
Innovstone Therapeutics Ltd. has disclosed integrin αLβ2 (LFA-1)/ICAM-1 interaction inhibitors and/or RASP-trapping agents reported to be useful for the treatment of dry eye syndrome.
Researchers at Carl von Ossietzky Universität Oldenburg generated retinal pigment epithelial cell lines lacking three RPGR isoforms and examined whether they showed the defects in ciliary structure and actin turnover known to occur in retinitis pigmentosa.
University of Eastern Finland has synthesized carbonic anhydrase II (CA2) inhibitors and melanin ligands. As such, they are described as potentially useful for the treatment of glaucoma, macular edema and retinal degeneration.
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