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 for diabetic macular edema (DME), demonstrating a good safety profile and significant reduction in central subfield thickness (CST) [1][5][9] - The study indicates the potential for RZ402 to serve as a first-line, non-invasive oral therapy for DME, which could alter long-term patient outcomes [2][3] Study Results - The Phase 2 study enrolled 94 participants in a randomized, double-masked, placebo-controlled design, evaluating RZ402 as a monotherapy over a 12-week period [2][6] - RZ402 showed a significant improvement in CST across all dosage levels compared to placebo, with a maximum reduction of approximately 50 microns (p=0.02) [6][9] - The 200 mg dose of RZ402 yielded the most substantial response, with over 20% of participants experiencing clinically significant improvements [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 safety assessments including ECGs and vital signs were unremarkable [11] Future Plans - The company plans to present further findings and data at an upcoming medical conference [7] - A virtual investor event is scheduled to discuss these topline results, indicating ongoing engagement with stakeholders [8] About DME and RZ402 - DME is a severe complication of diabetic retinopathy characterized by retinal swelling, and current treatments involve invasive anti-VEGF injections [8][9] - RZ402 is an oral, small molecule plasma kallikrein inhibitor designed to block bradykinin production, potentially reducing vascular leakage and inflammation associated with DME [9]