Macular Degeneration

FDA Issues a Complete Response Letter to the BLA for Abicipar Pegol for Treatment of Wet Age-Related Macular Degeneration

NORTH CHICAGO, Ill., June 26, 2020 /PRNewswire/ — Allergan, an AbbVie Company (NYSE: ABBV), and Molecular Partners (SIX: MOLN), a clinical-stage biotechnology company developing a new class of custom-built protein therapeutics known as DARPin® therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response …

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FDA Approves Updated Novartis Beovu Label to Include Additional Safety Information

Basel, June 11, 2020 — Novartis announced today that the US Food and Drug Administration (FDA) has approved a label update for Beovu® (brolucizumab) to include additional safety information regarding retinal vasculitis and retinal vascular occlusion1. This approval follows Novartis’ announcement that it would pursue worldwide label updates after a review and further characterization …

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Port Delivery System with Ranibizumab Shows Positive Phase 3 Results in Neovascular 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 topline results from the Phase III Archway study, evaluating Port Delivery System with ranibizumab (PDS) in people living with neovascular or “wet” age-related macular degeneration (nAMD). PDS is a permanent refillable …

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Samsung Bioepis Announces Interim Results from Phase 3 Trial of SB11, Proposed Ranibizumab Biosimilar, in Neovascular Age-Related Macular Degeneration

INCHEON, Korea–(BUSINESS WIRE)–Samsung Bioepis Co., Ltd. announced today that the primary endpoints have been met in the randomized, double-masked, phase 3 trial comparing the efficacy, safety and immunogenicity of SB11, a ranibizumab biosimilar candidate, to reference ranibizumab in patients with neovascular age-related macular degeneration (nAMD). “We are excited to share …

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Santen and TRACON Discontinue Development of DE-122 for Wet Age-Related Macular Degeneration

OSAKA, Japan and SAN DIEGO, March 09, 2020 (GLOBE NEWSWIRE) — Santen Pharmaceutical Co., Ltd. (Head Office: Osaka; hereinafter, “Santen”) and TRACON Pharmaceuticals, Inc. (Head Office: San Diego, CA; hereinafter, “TRACON”) today announced the discontinuation of the development of DE-122 for the treatment of wet age-related macular degeneration (wAMD) following …

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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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