4DMT Announces First Patient Enrolled in 4D-150 Phase 2 SPECTRA Clinical Trial in DME, and Expansion of 4D-150 Phase 2 Stage in PRISM Clinical Trial in Wet AMD

• First patient has been enrolled in the Dose Confirmation stage (n=18) of the Phase 2 SPECTRA clinical trial for intravitreal 4D-150 in patients with diabetic macular edema

• First patient enrolled in Population Extension cohort of Phase 2 stage of PRISM clinical trial in wet AMD (n=up to 45) to evaluate intravitreal 4D-150 in patients with lower anti-VEGF need compared with initial cohorts

• All PRISM patient cohorts to inform pivotal clinical trial design for 4D-150; FDA feedback on Phase 3 design expected in Q4 2023 with update expected in Q1 2024

• Initial interim data for SPECTRA Dose Confirmation and PRISM Population Extension cohort expected in 2024; guidance for randomized Phase 2 stage (n=50) in highest anti-VEGF need patients on-track for H1 2024

EMERYVILLE, Calif., Sept. 07, 2023 (GLOBE NEWSWIRE) -- 4D Molecular Therapeutics (Nasdaq: FDMT, 4DMT or the Company), a clinical-stage biotherapeutics company harnessing the power of directed evolution for targeted genetic medicines, today announced that the first patient has been enrolled in the Dose Confirmation stage of the Phase 2 SPECTRA clinical trial evaluating intravitreal 4D-150 in patients with diabetic macular edema (DME), and that a Population Extension cohort has been added to the 4D-150 Phase 2 stage of the PRISM Clinical Trial in wet age-related macular degeneration (wet AMD).

“We are delighted to be advancing 4D-150 in our Phase 2 SPECTRA clinical trial in patients with DME, and to further study intravitreal 4D-150 in a broader patient population in wet AMD,” said Robert Kim, M.D., Chief Medical Officer of 4DMT. “DME is a major cause of vision loss among people with diabetes and may lead to blindness. Anti-VEGF agents are considered the mainstay of therapy for DME, yet the treatment burden with the current standard of care remains high. Based on its unique, multitargeted inhibition of four VEGF family members and the favorable clinical profile observed to date in the Phase 1/2 trial in wet AMD, 4D-150 has the potential to provide durable suppression of key pathogenic mediators in DME following a single intravitreal injection that can be administered in-office. In wet AMD, we believe that by expanding the patient population treated with 4D-150, we will further characterize 4D-150 in advance of our planned Phase 3 clinical trials, while taking advantage of strong enrollment momentum at clinical sites to date.”