4D Molecular starts Phase 3 trial for diabetic eye disease drug

4D Molecular Therapeutics (NASDAQ:FDMT) has initiated its Phase 3 clinical trial, 4SIGHT, for its investigational drug 4D-150, which aims to treat diabetic macular edema (DME). The trial will enroll 514 treatment-naive DME patients across multiple sites, with the primary endpoint measuring non-inferiority in mean change from baseline in best corrected visual acuity at week 52.

The study will compare 4D-150 to aflibercept administered every eight weeks, with all patients receiving five aflibercept loading doses initially. The trial reported positive two-year data from its SPECTRA clinical trial, showing a mean improvement in visual acuity of 10.8 letters and a reduction in central subfield thickness of 176 micrometers.

4D-150 has received FDA Regenerative Medicine Advanced Therapy designation for DME and has alignment with the FDA and European Medicines Agency on potential regulatory filings.

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