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.

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.