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4DMT Presents Additional Positive Interim Data from Intravitreal 4D-150 Phase 1/2 PRISM Clinical Trial in Patients with Wet AMD at ASRS 2023
Dose response demonstrated in favor of highest tested dose of 3E10 vg/eye, including 100% reduction in supplemental anti-VEGF injections (4 of 4 evaluable
About this update from 4d Molecular Therapeutics, Inc.
[{"type":"text","content":"Dose response demonstrated in favor of highest tested dose of 3E10 vg/eye, including 100% reduction in supplemental anti-VEGF injections (4 of 4 evaluable patients injection-free) and a clinically meaningful reduction in mean central subfield thickness (CST) at 36 weeks in patient population with high anti-VEGF needAssessment of outcomes beyond 36 weeks in the 3E10 vg/eye dose cohort showed a durable reduction in supplemental anti-VEGF injections, with 3 of 4 evaluable participants remaining injection-free beyond one year and one patient remaining injection-free during a maximum follow-up of 80 weeks; no change in safety profile observedLower doses (1E10, 6E9 vg/eye) also highly active, with 5 of 10 patients requiring zero or one supplemental anti-VEGF injections and a 71% reduction in mean annualized supplemental anti-VEGF injection rate through 36 weeks Intravitreal 4D-150 remained well tolerated at all doses in all patients, with no Grade ≥1 inflammatory cells, hypotony, dose-limiting toxicities, or treatment-related serious adverse events (SAE) during follow-up through 36 weeks Phase 2 Dose Expansion (N=50) initial interim efficacy and safety data presentation expected at medical conference in H1 2024 EMERYVILLE, Calif., July 29, 2023 (GLOBE NEWSWIRE) -- 4D Molecular Therapeutics (Nasdaq: FDMT, 4DMT or the Company), a clinical-stage biotherapeutics company harnessing the power of directed evolution for targeted genetic medicines, today announced additional positive interim clinical data from the Phase 1 Dose Exploration stage (N=15) of the 4D-150 Phase 1/2 PRISM clinical trial for patients with wet age-related macular degeneration (wet AMD). The data were presented at the 2023 American Society of Retinal Specialists (ASRS) Annual Meeting in Seattle, Washington on Saturday, July 29 by Christine N. Kay, M.D., a vitreoretinal surgeon and the Director of Electrophysiology, Retinal Genetics, and Clinical Trials at Vitreoretinal Associates in Gainesville, Florida. 4D-150 is a potentially transformative genetic medicine that utilizes 4DMT’s evolved and customized retinotropic R100 vector, while targeting four VEGF family members. 4D-150 is being developed as a single dose, routine outpatient intravitreal therapy with the goal of reducing treatment burden and maintaining efficacy in patients with wet AMD and diabetic macular edema (...