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Wednesday, 4D Molecular Therapeutics, Inc.(NASDAQ:FDMT) unveiled interim 24-week data from the Population Extension cohort of its PRISM Phase 2 Clinical Trial.
The trial evaluates intravitreal 4D-150 in a broad wet AMD patient population.
The findings were presented at the American Society of Retina Specialists Annual Scientific Meeting.
The Phase 2 PRISM Population Extension cohort evaluated 45 wet AMD patients previously treated with anti-VEGF injections, with 30 patients at 3E10 vg/eye (the planned Phase 3 dose) and 15 at 1E10 vg/eye (the low dose control).
In the expanded Phase 2 dataset, 4D-150 allowed 77% of 30 patients to become injection-free after 24 weeks, with 60% on low-dose arm.
An anti-VEGF treatment reduction was observed at the planned Phase 3 dose (3E10 vg/eye), with an 89% reduction in the mean annualized injection rate and 93% receiving 0 or 1 injection.
The data also showed improved visual acuity and retina anatomic outcomes.
The study reported no significant inflammation or 4D 150–related serious adverse events.
Long-term follow-up of Phase 1 patients treated with 4D-150 indicated stable visual acuity and retinal thickness over two years.
4D-150 demonstrated safety and efficacy in the PRISM (wet AMD) and SPECTRA (DME) clinical trials.
No significant inflammation or serious adverse events were reported among 139 dosed patients across both trials.
Upcoming milestones include the final Phase 3 trial design update in September 2024 and the initiation of the first Phase 3 trial in the first quarter of 2025.
Further analyses from the PRISM and SPECTRA studies are expected in early 2025.
Price Action: FDMT shares are down 35.7% at $17.19 at last check Wednesday. During the premarket session, shares reached as high as $29.1.
Photo via Shutterstock
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