Business
4DMT Receives FDA Regenerative Medicine Advanced Therapy (RMAT) Designation for 4D-150 Genetic Medicine for Intravitreal Treatment of Wet AMD, the First RMAT Designation in Wet AMD
Designation follows interim Phase 1 PRISM clinical data for 4D-150 that demonstrated an encouraging safety, tolerability and clinical activity profile in
About this update from 4d Molecular Therapeutics, Inc.
[{"type":"text","content":"Designation follows interim Phase 1 PRISM clinical data for 4D-150 that demonstrated an encouraging safety, tolerability and clinical activity profile in patients with wet age-related macular degeneration (wet AMD) 4D-150 is the first therapeutic candidate to receive either RMAT or Breakthrough Designation for wet AMDRMAT designation follows Priority Medicines (PRIME) designation received from the European Medicines Agency (EMA) in October 2023Receiving both RMAT and PRIME enables increased collaboration between the FDA and EMA on regulatory approval planning, in addition to the opportunity for expedited product developmentInitial interim landmark data from 4D-150 Phase 2 PRISM randomized Dose Expansion stage (N=50 at 24 Weeks) in advanced, high treatment need wet AMD patients to be presented at Angiogenesis, Exudation, and Degeneration 2024 Conference on Saturday, February 3, 2024 at 4:20 p.m. ET EMERYVILLE, Calif., Dec. 21, 2023 (GLOBE NEWSWIRE) -- 4D Molecular Therapeutics (Nasdaq: FDMT, 4DMT or the Company), a leading clinical-stage genetic medicines company focused on unlocking the full potential of genetic medicines to treat large market diseases in ophthalmology and pulmonology, today announced that the U.S. Food and Drug Administration (FDA) has granted the RMAT designation for the investigational genetic medicine candidate 4D-150 for intravitreal treatment of wet age-related macular degeneration (wet AMD). The FDA granted RMAT designation based on the potential of 4D-150 to address the unmet medical need within this population. RMAT designation is part of the 21st Century Cures Act. The program was created to expedite the development and review of regenerative medicine therapies intended to treat, modify, reverse or cure a serious condition. Receiving RMAT designation offers sponsor companies all the benefits of the fast track and breakthrough therapy designation programs, allowing for early, close and frequent interactions with the FDA with the goal of expediting drug development. The designation follows interim Phase 1 PRISM clinical data for 4D-150 that demonstrated an encouraging safety, tolerability and clinical activity profile. 4D-150 has the potential to address an unmet medical need to safely maintain long-term visual acuity outcomes while avoiding the need for repeated intravitreal injections. 4DMT is currentl...