4D Molecular Therapeutics has revealed promising 60-week data from a clinical trial of its innovative gene therapy, 4D-150. This therapy is designed to combat diabetic macular edema (DME) by encoding aflibercept and a VEGF-C inhibitory sequence. Aflibercept, a key anti-VEGF drug, served as the active control in the study.
The trial results highlight 4D-150’s effectiveness in treating DME. Patients receiving the Phase 3 dose of 4D-150 experienced significant improvements, gaining an average of 9.7 letters in best corrected visual acuity (BCVA) and seeing a 174-micrometer reduction in central subfield thickness (CST). These changes showcase both visual and anatomical benefits.
Moreover, after three initial aflibercept doses, those on the Phase 3 dose of 4D-150 required 78% fewer supplemental injections compared to those who would typically use aflibercept 2 milligrams bi-monthly. Patients on the highest dose of 4D-150 also performed better than those on lower doses, with a 58% reduction in additional injections. Impressively, four out of nine patients on this dose were entirely free from additional injections, compared to just one out of eleven on lower doses.
These findings were presented by David Almeida at the American Society of Retina Specialists’ annual meeting. He emphasized that 4D-150 could revolutionize DME treatment by significantly reducing the burden of frequent interventions while ensuring lasting improvements in vision.
The therapy was well tolerated among participants, with no instances of intraocular inflammation or the need to adjust topical corticosteroid regimens. Importantly, there were no reported cases of severe complications such as hypotony, endophthalmitis, vasculitis, choroidal effusions, or retinal artery occlusion. Additionally, intraocular pressure remained stable throughout the study.
Interestingly, around 5.3% of diabetic patients are affected by DME, underscoring the potential impact of these advancements in their treatment options.
