Rezolute Reports Positive Phase 2 RZ402 Proof of Concept Study Topline Results

DENVER, Colo., May 22, 2024 ( Rezolute, Inc. (Nasdaq:RZLT) reported positive topline results from the Phase 2 clinical study of RZ402 in patients with DME who are naïve to or have received limited anti-vascular growth factor (anti-VEGF) injections, which met the study’s primary endpoints, including good safety profile and reduction in central subfield thickness (CST).

“The results are monumental for the DME community,” said Quan Dong Nguyen, MD, MSc, FAAO, FARVO, FASRS, Professor of Ophthalmology at the Byers Eye Institute, and Professor of Medicine and Professor of Pediatrics at the Stanford University School of Medicine, and a member of Rezolute’s Scientific Advisory Board. “I am impressed by the significant reduction in CST in this study across all three dosages as retinal thickness is the key biomarker to determine whether a therapy may offer a potential benefit to patients. These data are very encouraging and are supportive of the potential for a new first-line, non-invasive treatment for DME.”

“I am encouraged to see the initial results of this proof-of-concept study and am enthusiastic about the possibility of an oral therapy to treat DME,” said Arshad Khanani, MD, MA, FASRS, Clinical Professor at the Reno School of Medicine, University of Nevada, and Primary Investigator of the study. “Importantly, an oral therapy would afford us the opportunity to address both eyes and intervene much earlier, potentially altering the long-term prognosis for individuals with DME.”

“We are very excited about these results and, importantly, would like to thank the patients, the leading retina specialists across the country, and their motivated staff who all made this study possible,” said Raj Agrawal, MD, Vice President and Head of Ophthalmological Clinical Development at Rezolute.

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