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4DMT Receives RMAT Designation for 4D-150 Genetic Medicine in Wet AMD

4DMT Receives RMAT Designation for 4D-150 Genetic Medicine in Wet AMD

December 25, 2023

4D Molecular Therapeutics has secured the Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA for its investigational genetic medicine, 4D-150. This significant milestone positions 4D-150 as a potential game-changer in the treatment landscape for wet age-related macular degeneration (wet AMD).

The RMAT designation, granted under the 21st Century Cures Act, acknowledges the transformative potential of 4D-150 in addressing the unmet medical needs of individuals grappling with wet AMD. As part of the program, 4D Molecular Therapeutics will benefit from the advantages of expedited development and review, mirroring the fast track and breakthrough therapy designation programs. This facilitates enhanced collaboration and communication with the FDA, ultimately expediting the drug development process.

The decision to confer RMAT designation follows positive interim Phase 1 PRISM clinical data for 4D-150, showcasing promising safety, tolerability, and clinical activity. Notably, 4D-150 holds the promise of maintaining long-term visual acuity outcomes without the necessity for repeated intravitreal injections, addressing a crucial gap in current treatment modalities.

“We are honored to receive the first ever RMAT designation for an investigational treatment for wet AMD with our intravitreal 4D-150 genetic medicine,” said David Kirn, M.D., Co-founder and Chief Executive Officer of 4DMT. “This designation validates our belief in 4D-150’s potential to address the high unmet need of wet AMD patients, to maintain their visual acuity outcomes, and to reduce their treatment burden. We continue to work closely with the FDA and EMA on efficiently advancing 4D-150 development for both wet AMD and diabetic macular edema, and having both RMAT and PRIME designations enables us to further collaborate expeditiously in our efforts to advance development in both geographies.”

“Wet AMD patients are waiting for a durable therapy with the potential to significantly reduce treatment burden and preserve vision long term,” said Robert Kim, M.D., Chief Medical Officer of 4DMT. “We are grateful that the two largest pharmaceutical regulatory agencies in the world recognize 4D-150’s potential by awarding the unprecedented combination of both RMAT and PRIME designations in wet AMD. I am incredibly proud of the team at 4DMT for this accomplishment and we look forward to sharing initial interim data from our randomized Phase 2 Dose Expansion clinical trial in the highest anti-VEGF need patients in February at the 2024 Angiogenesis Conference.”

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