4DMT has enrolled first patients in its 4SIGHT global Phase 3 trial evaluating 4D-150 in treatment-naïve diabetic macular edema.
The randomized, double-masked, aflibercept 2 mg (Q8W) comparator-controlled study will enroll 514 patients with a primary endpoint of non-inferiority in mean change from baseline in best corrected visual acuity at Week 52 and key secondary endpoints that include treatment burden reduction and the proportion achieving a two-step or greater improvement in diabetic retinopathy severity at Week 52.
The trial includes five aflibercept loading doses, allows supplemental injections for both arms, and requires demonstration of aflibercept responsiveness after the first three loading doses for randomization.
The company reports updated two-year SPECTRA Part 1 data (N=22) showing a favorable safety profile with no intraocular inflammation or ocular serious adverse events and clinical activity at the Phase 3 dose (mean gain +10.8 letters BCVA; mean central subfield thickness reduction −176 µm) alongside substantial reductions in supplemental injections versus projected on-label aflibercept.
4D-150 holds FDA Regenerative Medicine Advanced Therapy designation, and the company claims alignment with FDA and EMA on potential regulatory filings.
DME affects an estimated one million individuals in the U.S., according to published research.
