4D Molecular completes enrollment of 50 patients in dose expansion of trial

4D Molecular Therapeutics announced that it has completed enrollment of the Phase 2 Dose Expansion stage of the PRISM clinical trial for patients with wet age-related macular degeneration or wet AMD over approximately two quarters, and that no significant 4D-150 safety events or inflammation have been reported to date. “The rapid enrollment of the Phase 2 Dose Expansion stage of the PRISM trial is indicative of the high demand by wet AMD patients and physicians for a new safe and effective therapy delivered by routine outpatient intravitreal injection with the potential to significantly reduce the need for frequent anti-VEGF injections,” said Robert Kim, M.D., Chief Medical Officer of 4DMT. “We thank the PRISM investigators and patients for their enthusiasm for this important study as we rapidly advance 4D-150 towards the next stage of development. As of July 3 for patients enrolled in Dose Expansion with maximum follow-up through 20 weeks, no treatment-emergent Grade greater than or equal to1 inflammatory cells or required deviations from the 20-week protocol-specified corticosteroid eyedrop taper were reported. In addition, no hypotony, no vasculitis and no treatment-related serious adverse events were reported. We expect to have initial discussions with the FDA on Phase 3 pivotal trial design for 4D-150 for patients with wet AMD in Q4 2023, and we expect to provide an update on pivotal trial plans in Q1 2024…We expect to enroll our first patient in the Phase 2 SPECTRA trial in Q3 2023. We remain committed to the advancement of our large market ophthalmology product candidates, including 4D-150 for wet AMD and DME as well as 4D-175 for geographic atrophy.”