4DMT Presents Positive 52-Week Results from Phase 2b Cohort of PRISM Wet AMD Study and Long-term Durability Data Supporting 4D-150 4FRONT Global Registration Program

Core Insights - 4D Molecular Therapeutics announced positive interim 52-week data from the Phase 2b Population Extension cohort of the PRISM clinical trial for 4D-150, targeting wet age-related macular degeneration (wet AMD) [1][2] - The data indicates that 4D-150 has the potential to become a foundational therapy for vascular retinal diseases, addressing the unmet need for long-lasting treatment options [2][8] Efficacy Results - In the Phase 2b trial, 4D-150 achieved an 83% reduction in injection burden compared to projected on-label aflibercept, with 70% of patients requiring 0-1 supplemental injections and 57% being injection-free through 52 weeks [6][7] - In the recently diagnosed subgroup, 87% required 0-1 supplemental injection and 80% were injection-free through 52 weeks, demonstrating significant efficacy [6][7] Safety Profile - 4D-150 was well tolerated, with only 2.8% of patients experiencing 4D-150-related intraocular inflammation, which was transient [7][8] - No serious adverse events such as hypotony, endophthalmitis, or retinal vasculitis were reported [8] Durability of Treatment - Durable and stable aflibercept expression was demonstrated across all cohorts, with follow-up data showing efficacy for up to two years [6][10] - Aqueous humor concentrations remained within the projected therapeutic range, indicating sustained delivery of the treatment [12] Future Developments - The company plans to initiate the 4FRONT-1 and 4FRONT-2 trials in Q1 and Q3 2025, respectively, with further data expected in Q4 2025 [6][12] - The primary endpoint data from both 4FRONT trials is anticipated in H2 2027 [12]