Rezolute Reports Positive Topline Results from Phase 2 Proof of Concept Study of RZ402 in Patients with Diabetic Macular Edema (DME)

Core Insights - Rezolute, Inc. announced positive topline results from the Phase 2 clinical study of RZ402, demonstrating a good safety profile and significant reduction in central subfield thickness (CST) in patients with diabetic macular edema (DME) [1][5][9] Study Results - The study enrolled 94 participants in a multi-center, randomized, double-masked, placebo-controlled design, evaluating RZ402 as a monotherapy over a 12-week treatment period [2][6] - RZ402 met both primary endpoints, showing a significant improvement in CST across all dosage levels compared to placebo, with a maximum reduction of approximately 50 microns (p=0.02) [5][6] - The 200 mg dose of RZ402 yielded the largest response, with a notable improvement of approximately 75 microns in patients with CST ≥400 microns [6][11] Safety Profile - RZ402 was reported to be safe and well-tolerated, with adverse events generally mild and comparable to placebo [11] - No ocular adverse effects typically associated with intravitreal injections were observed, and serious adverse events were deemed unrelated to the study drug [11] Treatment Implications - The results suggest the potential for RZ402 to serve as a first-line, non-invasive treatment for DME, allowing for earlier intervention and addressing both eyes simultaneously [2][3] - Current standard care involves invasive anti-VEGF injections, which can lead to treatment delays and compliance issues; RZ402's oral administration may alleviate these challenges [8][9] Future Plans - The company plans to present further findings at an upcoming medical conference and will host a virtual investor event to discuss the topline results [7][8]