4D Molecular Therapeutics (NASDAQ: FDMT) has released two-year data from its PRISM Phase 2b clinical trial evaluating 4D-150 in patients with wet age-related macular degeneration.
The data were presented by Carl Awh, M.D., FASRS, of Tennessee Retina, at the 44th Annual Scientific Meeting of the American Society of Retina Specialists in an oral presentation.
The Phase 2b trial enrolled 45 patients across two dose levels of a single intravitreal dose of 4D-150, with the 3E10 vg/eye dose selected for the ongoing 4FRONT Phase 3 clinical trials.
Results showed consistent maintenance of best corrected visual acuity and control of central subfield thickness across the two-year follow-up period.
The overall patient cohort demonstrated a 78% reduction in treatment burden, averaging 2.7 mean supplemental injections per patient compared to 12.0 injections projected with on-label aflibercept 2 mg Q8W.
A recently diagnosed subgroup, comprising patients diagnosed within six months of enrollment, showed an even stronger 87% overall treatment burden reduction, with only 1.6 mean supplemental injections per patient.
Safety data across the combined Phase 1/2a and 2b trials covering 71 patients showed that just 2.8% experienced mild intraocular inflammation within the first 28 weeks, with no new cases reported beyond that point.
No cases of hypotony, endophthalmitis, vasculitis, occlusive or non-occlusive retinal vasculitis, or choroidal effusions were observed across the entire study population to date.
David Kirn, M.D., Co-founder, President, and Chief Executive Officer of 4DMT, said: “Two-year PRISM data continue to strengthen our conviction in 4D-150’s potential to become a foundational backbone therapy for wet AMD.”
Kirn added: “The continued consistency in visual acuity and anatomic control with meaningful reduction in treatment burden and long-term tolerability reinforces our confidence in delivering a transformative treatment option for retina specialists and their patients.”
Carl Awh, M.D., FASRS, noted: “For retina specialists and our patients, maintaining the intensive injection schedule necessary to preserve vision is a tremendous challenge.”
Awh continued: “The two-year PRISM results demonstrate the potential of a single intravitreal administration of 4D-150 to provide long-term anti-VEGF and sustained disease control.”
Wet AMD is expected to affect more than 4 million individuals across major markets including the U.S., the EU, and Japan within the next five years, with an estimated 200,000 new diagnoses annually in the U.S. alone.
4D-150 is designed to provide multi-year, and potentially lifelong, sustained delivery of anti-VEGF biologics within the retina following a single intravitreal injection, targeting both wet AMD and diabetic macular edema.
