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4D Molecular Therapeutics enrolls first patients in Phase 3 trial for diabetic macular edema gene therapy
FDMT4D Molecular Therapeutics, Inc.
On September 28, 2026, 4D Molecular Therapeutics announced the enrollment of the first patients in its global Phase 3 4SIGHT clinical trial for 4D-150, a gene therapy candidate for diabetic macular edema. The trial involves 514 treatment-naïve patients and aims to demonstrate non-inferiority in visual acuity compared to aflibercept while reducing injection burden. Concurrently, the company released two-year data from the SPECTRA trial showing that patients receiving 4D-150 required significantly fewer supplemental injections than projected for standard of care, with an estimated 75% reduction in treatment burden under Phase 3 criteria. The filing notes FDA Regenerative Medicine Advanced Therapy designation and regulatory alignment for potential Biologics License Application filings based on combined SPECTRA, PRISM, and wet AMD data. 4D Molecular Therapeutics operates as a gene therapy company focused on developing treatments for retinal diseases.