4D-150 reduces annualized anti-VEGF injection rate in wet AMD at 24 weeks
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One intravitreal injection of 4D-150 helped reduce the mean annualized anti-VEGF injection rate in patients with wet age-related macular degeneration, according to a study presented at the American Society of Retina Specialists meeting.
“The PRISM phase 2 data at 24 weeks across a broad patient population with varying severity of disease, along with long-term data collected through up to 2.5 years, confirms 4D-150’s potential to significantly reduce the treatment burden and maintain vision through a safe, single intravitreal injection,” David Kirn, MD, co-founder and CEO of 4D Molecular Therapeutics, told Healio. “This data positions 4D-150 as an emerging long-acting, potentially best-in-class genetic medicine that can preserve vision and provide long-term disease maintenance with minimal to no downsides in terms of safety.”
Raj K. Maturi, MD, presented data from the phase 2 population extension cohort of the PRISM trial evaluating 4D-150 gene therapy in patients with wet AMD.
“It contains aflibercept as well as interfering RNA against VEGF-C, so you have four different pathways,” Maturi said.
The population extension study included 45 patients who received an intravitreal injection of aflibercept a week before receiving one of two doses of 4D-150. A second aflibercept injection was given at day 28.
Maturi said 4D-150 was found to be safe and well tolerated by patients. There were no drug-related serious adverse events in the study.
The mean reduction in annualized anti-VEGF injections was 89% in the 3 × 1010 vg/eye group and 91% in the 1 × 1010 vg/eye group; 77% of patients in the first group were injection-free at week 24 compared with 60% in the second group.
Maturi said the 3 × 1010 vg/eye group had durable improvement in best corrected visual acuity and stable central subfield thickness. All 30 patients who received 3 × 1010 vg/eye also completed prophylactic steroids, and none of them had to restart.
“Initiation of a phase 3 program is anticipated in the near future,” Maturi said.
4DMT is working with the FDA and the European Medicines Agency to finalize a phase 3 clinical trial design with the goal of trial initiation in the first quarter of 2025, according to Kirn.
“In addition, we plan to share long-term follow-up data from the severe and broad patient populations in a regular cadence going forward to continue showcasing the durable, multiyear benefits of 4D-150 from the PRISM study,” he said. “We also expect data readouts from the SPECTRA study in diabetic macular edema in Q4 this year.”
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Maturi R. Phase 2 population extension cohort in the PRISM trial evaluating 4D-150 in adults with neovascular age-related macular degeneration. Presented at: American Society of Retina Specialists annual meeting; July 17-20, 2024; Stockholm.
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