FDMT - 4DMT Presents Injection-Free Subgroup Analyses from 4D-150 Phase 2 PRISM Randomized Dose Expansion Cohort in Wet AMD Patients with Severe Disease Activity & High Treatment Burden at the Clinical Trials at the Summit 2024 Meeting | Benzinga
- Injection-free subgroup results demonstrated that a single intravitreal dose of 4D-150 without any supplemental anti-VEGF injections resulted in stable mean visual acuity that was equal to or higher than in the standard bimonthly aflibercept control group at all six timepoints through Week 24
- Single intravitreal 3E10 vg/eye dose resulted in sustained reduction and stabilization of mean central subfield thickness (CST) compared to aflibercept at all timepoints
- In the 3E10 vg/eye injection-free subgroup, the mean difference versus aflibercept in CST change from baseline for Weeks 20 and 24 was -31 microns in favor of 4D-150
- Injection-free subgroup analyses reinforce previously reported positive 4D-150 Phase 2 PRISM topline results
- Interim 24-week landmark analysis from Phase 2 PRISM Population Extension cohort evaluating 4D-150 in broader wet AMD population expected to be presented at the American Society of Retina Specialists (ASRS) Annual Scientific Meeting on July 17, 2024
EMERYVILLE, Calif., June 08, 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 presented supplemental aflibercept injection-free subgroup analyses of the previously reported 24-week landmark results from the randomized Dose Expansion cohort 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. The data were presented today at Clinical Trials at the Summit 2024 in Park City, Utah, by Carl Danzig, M.D., Rand Eye Institute, Deerfield Beach, Florida.
"The injection-free subgroup analyses demonstrate the potential for a single intravitreal 3E10 vg dose of 4D-150 to improve and stabilize retinal anatomy while improving or stabilizing vision in the most severe form of wet AMD with the highest VEGF treatment burden, without the need for any supplemental treatment through 24 weeks in the majority of patients treated," said Robert Kim, M.D., Chief Medical Officer of 4DMT. "4D-150 to date has shown robust clinical activity with a favorable safety profile, and the data provide additional evidence that 4D-150 has the potential to treat all patients suffering from wet AMD. We look forward to sharing interim results from the Population Extension cohort of PRISM at ASRS in July 2024, and an update on our Phase 3 clinical trial design in the third quarter ...