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topicnews · September 18, 2024

4DMT highlights robust and sustained clinical activity for 4D-150 and 4FRONT Phase 3 program design at 4D-150 Wet AMD Development Day Page 1

4DMT highlights robust and sustained clinical activity for 4D-150 and 4FRONT Phase 3 program design at 4D-150 Wet AMD Development Day Page 1

  • 4D-150 demonstrated robust and durable clinical activity in all patient groups with wet age-related macular degeneration (wet AMD) based on the longest available follow-up data

    • In the general population (Phase 2b), 70% of patients were injection-free for 52 weeks
    • In patients with severe disease (Phase 1/2a), a total of 83% fewer injections per year over 52 weeks
  • 4D-150 remains safe and well tolerated, with a numerically similar intraocular inflammation (IOI) profile (2.8% transient 1+ vitreous cells) as approved anti-VEGF agents.
  • The 4FRONT Phase 3 program is designed to maximize the potential of 4D-150, including the probabilities of clinical, regulatory and commercial success in global markets
  • The corporate webcast will take place on September 18, 2024 at 4:15 p.m. ET.

EMERYVILLE, Calif., Sept. 18, 2024 (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 diseases with high market potential, today announced data demonstrating continued robust and durable clinical activity based on the longest interim follow-up data from the PRISM Phase 1/2 clinical trial and the 4FRONT Phase 3 study design, presented at its 4D-150 Wet AMD Development Day.

“We continue to build support for 4D-150, with positive interim data from PRISM demonstrating a significant reduction in overall treatment burden and potential multi-year clinical benefit in previously treated patients, with an emerging safety profile comparable to approved anti-VEGF agents. In addition, we have assembled an exceptional leadership team with extensive experience in late-stage drug development, regulation and commercialization in major ophthalmology markets to design and execute our upcoming pivotal trials,” said David Kirn, MD, co-founder and CEO of 4DMT. “We expect to initiate 4FRONT-1, our first 4D-150 Phase 3 trial in wet AMD, in the first quarter of 2025. We look forward to continuing the rapid advancement of this potentially paradigm-shifting product candidate that pushes the limitations of current treatment options for patients with wet AMD.”