4DMT Announces Positive Phase 2 PRISM Interim Results for Intravitreal 4D-150 in a Broad Wet AMD Population Affirming Favorable Safety Profile and Robust Clinical Activity

• Robust reduction in anti-VEGF injection treatment burden through Week 24 achieved in 30 patients at planned Phase 3 dose (3E10 vg/eye) with 89% reduction in annualized injection rate; 93% of patients received 0 or 1 injection and 77% were injection-free
• Improvement in mean best corrected visual acuity (BCVA) from baseline through Week 24 achieved at 3E10 vg/eye dose (+4.2 letters); dose response in favor of 3E10 vg/eye dose demonstrated (+5.7 letters vs low dose)
• 3E10 vg/eye dose demonstrated sustained and greater anatomic control without fluctuations
• Favorable safety profile confirmed in 139 patients treated to date with 4D-150 across wet age-related macular degeneration (wet AMD; PRISM trial) and diabetic macular edema (DME; SPECTRA trial)
• No significant inflammation reported in 51 patients treated to date with 3E10 vg/eye dose and topical corticosteroid regimen
• Company to host live webcast today at 6:30 a.m. ET with Arshad M. Khanani, M.D., M.A., FASRS, lead Principal Investigator in the PRISM clinical trial

Excerpt from the Press Release:

EMERYVILLE, Calif., July 17, 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 initial interim 24-week landmark data from the Population Extension cohort of the PRISM Phase 2 Clinical Trial, which evaluated intravitreal 4D-150 in a broad wet AMD patient population. The data were presented by Raj K. Maturi, M.D., in an oral presentation titled, “Phase 2 Population Extension Cohort in the PRISM Trial Evaluating 4D-150 in Adults with Neovascular Age-related Macular Degeneration,” at the American Society of Retina Specialists (ASRS) Annual Scientific Meeting held in Stockholm, Sweden.

“The positive interim data presented today, coupled with previously reported data from the Dose Expansion cohort of high treatment burden patients, further reinforce our planned regulatory pathway demonstrates 4D-150’s broad potential to treat and preserve vision for the long term for all patient populations with wet AMD,” said David Kirn, M.D., Co-founder and Chief Executive Officer of 4DMT. “In addition, the growing safety and efficacy database for 4D-150 continues to validate the product candidate’s potential as a pipeline-in-a-product, with multiple potential multi-billion ophthalmology market opportunities including wet AMD, DME and diabetic retinopathy (DR). We anticipate data readouts from the SPECTRA study in DME in Q4 this year, which we believe will have potential readthrough to DR.”

“The initial benefits of the current treatment paradigm of repeated bolus anti-VEGF injections are not maintained long-term in wet AMD patients due to undertreatment and fluctuations in retinal thickness, leading to vision loss over time,” said Robert Kim, M.D., Chief Medical Officer. “The data presented on 4D-150 continue to show its promise as a potentially safe, routine and one-time intravitreal treatment with the long-term objective to preserve vision for millions of wet AMD patients, regardless of their treatment burden or disease severity.

Click the button below to read the entire Press Release:

Continue Reading The Press Release