After a single intravitreal dose of 4D-150, visual acuity and anatomic control was maintained with consistent and durable treatment burden reduction through 2 years
4D-150 continues to be well tolerated with no new safety or intraocular inflammation findings
EMERYVILLE, Calif., July 18, 2026 (GLOBE NEWSWIRE) -- 4D Molecular Therapeutics (Nasdaq: FDMT, 4DMT or the Company), a leading late-stage biotechnology company advancing durable and disease-targeted therapeutics with potential to transform treatment paradigms and provide unprecedented benefits to patients, today announced positive 2-year data from the PRISM Phase 2b clinical trial evaluating 4D-150 in a broad wet age-related macular degeneration (wet AMD) population. The data were presented by Carl Awh, M.D., FASRS, Tennessee Retina, in an oral presentation titled "2-Year Follow Up: PRISM Phase 2b Clinical Trial Evaluating Investigational 4D-150, an Intravitreal Gene Therapy, in a Broad Neovascular AMD Population" at the 44th Annual Scientific Meeting of the American Society of Retina Specialists (ASRS).
2-Year Data from PRISM Phase 2b Clinical Trial (Data Cutoff May 18, 2026):
Trial and Patient Cohort Overview
The Phase 2b trial enrolled 45 patients at two dose levels of a single intravitreal dose of 4D-150 (3E10 and 1E10 vg/eye); 3E10 vg/eye was chosen as the dose for the 4FRONT Phase 3 clinical trials
The Phase 2b overall cohort enrolled patients with broad disease activity (n=30 dosed with 3E10 vg/eye and n=15 dosed with 1E10 vg/eye)
The Phase 2b cohort subgroup comprised recently diagnosed patients (diagnosed within 6 months, n=15 at 3E10 vg/eye), which is most comparable to the population enrolled in the 4FRONT Phase 3 clinical trials
Phase 2b Efficacy Results Through 2 Years:
Consistent maintenance of best corrected visual acuity (BCVA)
Consistent control of central subfield thickness (CST) as measured by optical coherence tomography
Consistent, durable and clinically meaningful reduction in treatment burden:
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Overall cohort:
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78% overall treatment burden reduction (2.7 mean supplemental injections per patient vs. 12.0 injections projected with on-label aflibercept 2 mg Q8W)
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Recently diagnosed subgroup:
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87% overall treatment burden reduction (1.6 mean supplemental injections per patient vs. 12.0 injections projected with on-label aflibercept 2 mg Q8W)
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Dose response maintained throughout 2 years in favor of the Phase 3 dose
Safety Data for Phase 3 Dose in Overall PRISM Phase 1/2a & 2b Clinical Trial (n=71)
4D-150 continues to be well tolerated:
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Intraocular inflammation:
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As previously reported, within approximately the first 6 months (28 weeks) post-4D-150 dosing, 2.8% (2 of 71) of patients had 4D-150-related 1+ (mild) intraocular inflammation (IOI) (SUN/NEI scales), which were transient 1+ vitreous cells noted at a single timepoint
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Following the first 28 weeks post-4D-150 dosing, no new cases of inflammation with 2 to more than 4 years of follow-up on all patients as of the data cutoff
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No 4D-150-related hypotony, endophthalmitis, vasculitis, occlusive/non-occlusive retinal vasculitis or choroidal effusions observed to date
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