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Macular Degeneration

FDA Approves Novartis’ Beovu Injection for Treatment of Wet Age-Related Macular Degeneration

Basel, October 8, 2019 — Novartis today announced that the U.S. Food and Drug Administration (FDA) approved Beovu® (brolucizumab) injection, also known as RTH258 for the treatment of wet age-related macular degeneration (AMD)[1]. Beovu is the first FDA approved anti-VEGF to offer both greater fluid resolution versus aflibercept and the ability …

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FDA Accepts Allergan’s BLA for Abicipar Pegol in Patients with Wet Age-Related Macular Degeneration

DUBLIN, Sept. 9, 2019 /PRNewswire/ — Allergan plc (NYSE: AGN), a leading global pharmaceutical company with a heritage of more than 70 years in eye care, and Molecular Partners (SIX: MOLN), a clinical-stage biotechnology company developing a new class of drugs known as DARPin® platform, today announced that the U.S. …

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FDA Approves Regeneron’s Eylea (aflibercept) Injection Prefilled Syringe

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has approved the Chemistry, Manufacturing and Controls (CMC) Prior-Approval Supplement (PAS) for the EYLEA® (aflibercept) Injection prefilled syringe. The 2 mg, single-dose, sterilized prefilled syringe provides physicians with a new way to administer EYLEA that …

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Alkahest Investigational CCR3 Inhibitor Meets Primary and Secondary Endpoints in Phase 2a Study in Refractory Neovascular AMD

SAN CARLOS, Calif., July 29, 2019 (GLOBE NEWSWIRE) — Alkahest, Inc., a clinical stage biotechnology company focused on developing transformative therapies to treat age-related diseases, announced that its phase 2a trial of AKST4290, an orally-administered small molecule CCR3 inhibitor, met the primary endpoint of achieving an increase in best corrected …

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Allegro Announces Positive Topline Results of Phase 2 Study of Risuteganib in Patients with Intermediate Dry Age-Related Macular Degeneration

SAN JUAN CAPISTRANO, Calif.–(BUSINESS WIRE)–Allegro Ophthalmics, LLC, a privately held biopharmaceutical company focused on the development of novel anti-integrin therapies for the treatment of ocular diseases, today announced positive topline results of its U.S. Phase 2 study of risuteganib (Luminate®) for the treatment of intermediate nonexudative age-related macular degeneration (dry …

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FDA Approves Regeneron’s Eylea Injection for Treatment of all Stages of Diabetic Retinopathy

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has approved EYLEA® (aflibercept) Injection to treat all stages of diabetic retinopathy (DR), and thereby reduce the risk of blindness. “Millions of people have been robbed of their vision due to the progression of diabetic retinopathy,” said David Brown, M.D., F.A.C.S., …

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FDA Accepts and Grants Priority Review of Novartis’ Brolucizumab for Patients with Wet Age-Related Macular Degeneration

Basel, April 15, 2019 – Novartis announced that the US Food and Drug Administration (FDA) accepted the company’s Biologics License Application (BLA) for brolucizumab (RTH258) for the treatment of wet age-related macular degeneration (AMD), also known as neovascular AMD, or nAMD. Seeking to make brolucizumab available as quickly as possible, Novartis used …

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Ophthotech Announces Results from Phase 2a Safety Trial of Zimura in Combination with Lucentis in Wet Age-Related Macular Degeneration

NEW YORK–(BUSINESS WIRE)–Ophthotech Corporation (NASDAQ:OPHT) today announced the results from its Phase 2a safety trial of Zimura® (avacincaptad pegol), the Company’s complement factor C5 inhibitor, in patients with wet age-related macular degeneration (AMD). This trial was designed to evaluate the safety of different dosage regimens of Zimura combination therapy in wet AMD …

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Ophthotech Expands Gene Therapy Pipeline with Exclusive Option for Novel Product Candidates to Treat Best Vitelliform Macular Dystrophy

NEW YORK–(BUSINESS WIRE)–Ophthotech Corporation (NASDAQ:OPHT) announced today that it has entered into an exclusive option agreement with the University of Pennsylvania (Penn) and the University of Florida Research Foundation (UFRF) for rights to negotiate to acquire an exclusive global license to develop and commercialize novel adeno-associated virus (AAV) gene therapy product …

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New Stairway Study Data Shows Potential for Extended Durability with Faricimab in Wet Age-Related Macular Degeneration

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced positive results from the Phase II STAIRWAY study which explored the extended durability of faricimab (RG7716) in the treatment of wet age-related macular degeneration (AMD), a leading cause of blindness in people …

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