On Saturday, 4D Molecular Therapeutics ( FDMT ) announced initial interim 52-week data from the Phase 2b Population Extension cohort of the PRISM trial of 4D-150 in a broad wet age-related macular degeneration (wet AMD) patient population.

Additional data were provided on the durability of aflibercept expression for up to two years.

Topline 52-Week Efficacy Results for 4D-150 3E10 vg/eye (Planned Phase 3 Dose) from Phase 2b Population Extension Cohort of PRISM (Data Cut-Off January 15, 2025):

Also Read: 4D Molecular Therapeutics Stock Falls After Follow-Up Data From Mid-Stage Study Of Vision Loss Drug Candidate

In a subgroup of 30 patients who received supplemental injections of Regeneron Pharmaceuticals Inc’s Eylea (aflibercept), an 83% reduction in injection burden was observed. This represents 0.97 mean supplemental injections per patient over 52-weeks vs. 6.0 injections projected with on-label aflibercept 2 mg Q8W.

70% required 0-1 supplemental injection, and 57% were injection-free through 52 weeks.

Improved and maintained best corrected visual acuity (BCVA) of +2.2 letters.

Durable central subfield thickness (CST) improved with fewer fluctuations, as measured by optical coherence tomography (OCT), of -11 µm; -13 µm in supplemental injection-free patients.

In the recently diagnosed subgroup, 87% required 0-1 supplemental injection, and 80% were injection-free through 52 weeks.

A 94% reduction in injection burden was observed over 52 weeks vs. 6.0 injections projected with on-label aflibercept 2 mg Q8W

Improved and maintained BCVA of +3.1 letters

Durable CST improvement with fewer fluctuations, as measured by OCT, of -10 µm; -20 µm in supplemental injection-free patients

4D-150 continues to be well tolerated during up to three years of follow-up in all patients treated with 3E10 vg/eye

No 4D-150–-related hypotony, endophthalmitis, vasculitis, occlusive/non-occlusive retinal vasculitis, or choroidal effusions have been observed to date

4D-150 Program Milestones

4FRONT-1 and 4FRONT-2 Phase 3 trials are expected to initiate in Q1 and Q3 2025, respectively.

Two-year Phase 1/2a and 18-month Phase 2b PRISM data are expected in Q4 2025.

Primary endpoint 52-week topline data from both 4FRONT-1 and 4FRONT-2 expected in H2 2027.

Price Action: FDMT stock is down 8.54% at $5.46 at last check Monday.

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