Phase 2 study of potential DME oral therapy meets primary endpoints

Key Takeaways

• RZ402, a potential oral therapy for diabetic macular edema (DME), reduced an anatomical marker of edema at all dose levels.
• The safety profile was good, with generally mild adverse events.

A proof-of-concept phase 2 clinical study of RZ402, a potential oral therapy for DME, enrolled 94 participants with DME who were randomly assigned to receive either active treatment with RZ402 at one of three different doses or placebo once daily for 12 weeks. Results show that RZ402 met its primary endpoints of safety and reduction in central subfield thickness (CST), according to a press release from Rezolute. (CST increases in patients with DME; reduction of CST is a common endpoint for DME clinical trials. Primary endpoints measure outcomes that will answer the primary (or most important) question being asked by a trial, such as whether a new treatment is better at treating a disease than the standard therapy.)

“As a field, we have been evaluating noninvasive treatment options (eye drops and oral pills) to address DME early and reduce treatment burden,” primary investigator Arshad M. Khanani, MD, MA, FASRS, told Healio. “Importantly, an oral therapy would afford us the opportunity to address both eyes and intervene much earlier, potentially altering the long-term prognosis for our patients with DME.”

“The recent results from the phase 2 proof-of-concept study evaluating safety and anatomic benefit of RZ402 in DME are encouraging,” Khanani added. “We need a longer-term study to see the effect of RZ402 on CST and especially best corrected visual acuity…”

Edited by Miriam Kaplan, PhD

Source: Anthony DeFino, Healio Ocular Surgery News, May 24, 2024; see source article