Rezolute reports positive Phase 2 results for RZ402 in DME; CST reduced up to ~50 microns

Rezolute, Inc.

Phase 2 study of 94 DME patients met primary endpoints: CST reduction (p=0.02) and good safety profile.
CST improvement up to ~50 microns; 200 mg dose showed largest response; sub-analysis at CST ≥400 showed ~75 micron improvement.
RZ402 safe and well-tolerated; AEs mild and comparable to placebo; no ocular adverse effects typical of intravitreal injections.
No significant BCVA improvement, consistent with study duration; five 200 mg patients (20%) had 1-step DRSS improvement.
Target concentrations exceeded at all three doses (50, 200, 400 mg) supporting once-daily oral dosing.

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