(RTTNews) - 4D Molecular Therapeutics, Inc. (FDMT), a late-stage biotechnology company, announced positive 2-year data from the Phase 1/2 PRISM trial, including a Phase 2b cohort evaluating 4D-150 in patients with wet age-related macular degeneration.
Wet age-related macular degeneration
Wet age-related macular degeneration (Wet AMD) is characterised by abnormal growth of blood vessels in the macula, the central area of the retina. This leads to macular neovascularisation (MNV), causing retinal oedema, bleeding, scarring, visual distortion, and reduced visual acuity. According to the company, about 200,000 individuals are newly diagnosed with the disease in the U.S. each year.
4D-150 4D-150 is an investigational Adeno-Associated Virus (AAV)-based gene therapy designed to enable sustained retinal production of aflibercept and anti-VEGF-C following a single intravitreal injection, with the aim of reducing the need for frequent anti-VEGF injections in wet AMD and diabetic macular edema (DME). 4D-150 is also being evaluated in the Phase 3 4FRONT-1 and 4FRONT-2 trials for Wet AMD patients in North America and internationally.
PRISM Trial The Phase 1/2 PRISM trial is a dose-escalation, randomised, placebo-controlled, extension study evaluating 4D-150 in adults with Wet AMD. The primary endpoint is safety and tolerability, while secondary endpoints include the number of supplemental aflibercept injections over 52 weeks and changes from baseline in best corrected visual acuity (BCVA) and central subfield thickness (CST).
Clinical Highlights
The Phase 2b cohort of the trial enrolled 45 patients with wet AMD who received a single intravitreal dose of 4D-150 at either 3E10 or 1E10 vg/eye; the 3E10 vg/eye dose was selected for the Phase 3 4FRONT trials.
The study included 30 patients at the 3E10 vg/eye dose and 15 patients at the lower dose, including a subgroup of 15 recently diagnosed patients within six months, which closely matches the Phase 3 study population.
Through two years, 4D-150 maintained best corrected visual acuity (BCVA) and retinal thickness (CST) while delivering a durable reduction in treatment burden.
In the overall Phase 2b cohort, 4D-150 reduced treatment burden by 78%, with patients requiring 2.7 supplemental injections versus 12 projected injections when using on-label aflibercept 2 mg every 8 weeks.
While in the recently diagnosed subgroup, treatment burden was reduced by 87%, with patients requiring an average of 1.6 supplemental injections.
A dose-response favouring the Phase 3-selected dose (3E10 vg/eye) was maintained.
4D-150 continued to demonstrate a favourable safety profile in 71 patients across the PRISM Phase 1/2a and Phase 2b trials. Only 2.8% (2 of 71) of patients experienced mild, transient intraocular inflammation within the first 28 weeks after dosing.
According to the company, no new cases of inflammation were reported during more than four years of follow-up. No treatment-related hypotony, endophthalmitis, retinal vasculitis, or choroidal effusions were observed.
FDMT closed Friday's (17.07.2026) trade at $10.99, up 1.38%. In the Pre-market, FDMT is trading up 4.20% at $11.45.
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