Abbvie Inc.’s FDA clearance of Vuity (pilocarpine HCl ophthalmic solution) 1.25% for the treatment of presbyopia in adults, could bring relief to about 128 million Americans: almost half of the U.S. population, the company said. It’s the first and only eye drop given U.S. regulators’ go-ahead for what’s known as age-related blurry near vision – but plenty more have generated clinical data.
The third time proved the charm for Adamis Pharmaceuticals Corp.’s high-dose naloxone injection, Zimhi, which gained FDA approval for use in treating opioid overdose, nearly three years after the San Diego-based company first submitted an NDA.
LONDON – Intellia Therapeutics Inc. is to receive 10% of the equity in Sparingvision SAS as part of a deal giving the French ophthalmology specialist certain exclusive rights to in vivo CRISPR/Cas9 technologies in the treatment of ocular diseases.
When an independent data monitoring committee told Immunocore Ltd. plc’s David Berman in November that tebentafusp had met a phase III study’s pre-defined boundaries for statistical significance in overall survival (OS) after its first pre-planned interim analysis, the head of R&D was shocked.
Biogen Inc. and Samsung Bioepis Co. Ltd. gained FDA clearance for Byooviz (ranibizumab-nuna), a biosimilar that references the VEGF therapy Lucentis (ranibizumab) from Roche Holding AG, as a treatment for wet age-related macular degeneration, macular edema following retinal vein occlusion and myopic choroidal neovascularization. Byooviz is the first ophthalmology biosimilar to win the go-ahead in the U.S., and was approved in the EU on Aug. 18, 2021, followed by the U.K. on Aug. 31, 2021.
Aerie Pharmaceuticals Inc.’s wide-net endpoint approach with the phase IIb study called Comet-1 seemed less than appreciated by the stock market as the firm unveiled top-line data in dry eye disease with AR-15512.
Abbvie Inc. and Regenxbio Inc. have announced a partnership to develop and commercialize RGX-314, a potential one-time gene therapy for the treatment of wet age-related macular degeneration (wet AMD), diabetic retinopathy and other chronic retinal diseases. Under the terms of the agreement, Abbvie will pay Regenxbio $370 million up front, plus up to $1.38 billion in additional development, regulatory and commercial milestones. The deal gives '314 – already the most advanced gene therapy in wet AMD – another potential edge against its nearest competitor, Adverum Biotechnologies Inc.’s ADVM-022.
Apellis Pharmaceuticals Inc.’s win with one phase III trial and narrow miss with an identical one testing pegcetacoplan in geographic atrophy secondary to age-related macular degeneration caused Wall Street to punish the company while rewarding competitor Iveric Bio Inc.
Samsung Bioepis Co. Ltd. has emerged as the first company to obtain marketing authorization from the EMA for a biosimilar of Lucentis (ranibizumab), a significant development for the Korean biosimilar specialist. The approval comes less than two months after the company received a positive opinion from the EMA’s CHMP for Byooviz (ranibizumab), formerly called SB-11.
Visus Therapeutics Inc. has expanded its ophthalmic drug portfolio, in-licensing investigational therapies for glaucoma and age-related macular degeneration from Cella Therapeutics LLC, which will be developed by Finland’s Delsitech Ltd. using its extended-release depot technology.
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