4D-150 - (PRISM)

July 18, 2026: 4D Molecular Therapeutics (NASDAQ: FDMT) reported positive 2-year results from the PRISM Phase 2b trial of 4D-150, an investigational single-dose intravitreal gene therapy, in a broad wet age-related macular degeneration (wet AMD) population. Data (cutoff May 18, 2026) were presented in an oral session at the 44th Annual Scientific Meeting of the American Society of Retina Specialists (ASRS).

PRISM Phase 2b enrolled 45 patients across two dose levels (3E10 and 1E10 vg/eye); 3E10 vg/eye was selected as the dose for the ongoing 4FRONT Phase 3 trials. Through 2 years, the study showed maintenance of best corrected visual acuity (BCVA) and control of central subfield thickness (CST), with durable reduction in anti-VEGF treatment burden. In the overall cohort, mean supplemental injections were 2.7 per patient vs 12.0 projected with on-label aflibercept 2 mg Q8W (78% reduction); in a recently diagnosed subgroup (n=15 at 3E10), mean supplemental injections were 1.6 vs 12.0 (87% reduction). A dose response favoring the Phase 3 dose was maintained over 2 years.

Safety for the Phase 3 dose across PRISM Phase 1/2a and 2b (n=71) remained favorable: 2.8% (2/71) had mild (1+) intraocular inflammation within ~28 weeks, transient at a single timepoint, with no new inflammation reported after 28 weeks and no observed hypotony, endophthalmitis, vasculitis, retinal vasculitis, or choroidal effusions to date.