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

Core Insights - 4D Molecular Therapeutics announced positive interim data from the PRISM Phase 2 Clinical Trial, demonstrating significant reductions in treatment burden and improvements in visual acuity for patients with wet age-related macular degeneration (wet AMD) [2][3][11] Clinical Trial Results - The trial showed an 89% reduction in the annualized injection rate, with 93% of patients receiving 0 or 1 injection and 77% being injection-free at the planned Phase 3 dose of 3E10 vg/eye [2][13] - Mean best corrected visual acuity (BCVA) improved by +4.2 letters from baseline, with a dose response favoring the 3E10 vg/eye dose showing a +5.7 letter improvement compared to the low dose [2][13] - The 3E10 vg/eye dose demonstrated sustained anatomic control without fluctuations, with a decrease in central subfield thickness (CST) from baseline [2][13] Safety Profile - The safety profile of 4D-150 was favorable, with no significant inflammation reported in 51 patients treated with the 3E10 vg/eye dose and a topical corticosteroid regimen [2][7] - No serious adverse events or significant ocular complications were observed across the 139 patients treated in both the PRISM and SPECTRA trials [7][13] Market Potential - 4D-150 is positioned as a potential pipeline-in-a-product with multiple opportunities in the multi-billion dollar ophthalmology market, including wet AMD, diabetic macular edema (DME), and diabetic retinopathy (DR) [3][10] - The company anticipates further data readouts from the SPECTRA study in DME in Q4 2024, which may provide insights applicable to DR [3][8] Future Plans - The company is in the process of aligning Phase 3 clinical trial plans with the FDA and EMA, with an update on the final trial design expected in September 2024 and the first Phase 3 trial initiation anticipated in Q1 2025 [8][11]