4DMT Presents Positive Interim Data from Randomized Phase 2 PRISM Clinical Trial of Intravitreal 4D-150 Demonstrating Favorable Tolerability & Clinical Activity in Wet AMD

• 51 wet AMD patients with severe disease activity (mean of 442 µm central subfield thickness & presence of retinal fluid) and high treatment burden (mean of 10 anti-VEGF injections in preceding 12 months) were randomized to high (3E10 vg/eye) or low (1E10 vg/eye) dose 4D-150 or aflibercept control regimen
• 4D-150 was well tolerated with a favorable safety profile when evaluated through up to 48 weeks of follow-up: no significant inflammation observed (including no Grade ≥1+ inflammation in high dose patients) and all patients remained off topical steroids
• High dose 4D-150 resulted in an 89% reduction in the annualized anti-VEGF injection rate; 84% of patients received 0 or 1 injection, and 63% were injection-free through 24 weeks; visual acuity & central subfield thickness were both stable vs. aflibercept
• Positive interim results enable rapid advancement towards pivotal development, with Phase 3 clinical trial initiation expected in Q1 2025
• Company to host webcast on Monday, February 5, 2024 at 8:00 a.m. ET
  

EMERYVILLE, Calif., Feb. 03, 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 large market diseases, today announced positive interim data from the Phase 2 PRISM clinical trial evaluating intravitreal 4D-150 in wet age-related macular degeneration (wet AMD) patients with severe disease activity and a high treatment burden. Data presented at the Angiogenesis, Exudation, and Degeneration 2024 Conference by Arshad M. Khanani, M.D., M.A., FASRS, consisted of 24-week landmark results from the randomized Phase 2 Dose Expansion cohort of the PRISM clinical trial.

“We are thrilled today to announce positive interim results that strongly validate 4D-150’s potential as a safe, convenient, durable and transformational intravitreal therapeutic for wet AMD patients, with a goal of preserving vision for the longer term,” said David Kirn, M.D., Co-founder and Chief Executive Officer of 4DMT. “We believe 4D-150 has the potential to disrupt the current treatment paradigm in these patients and that these results continue to highlight the power and value of our intravitreal R100 vector invented at 4DMT. I would like to thank the patients and investigators who are participating in the PRISM trial who helped to achieve this important milestone.”