Eyebiotech Limited (“EyeBio”) announced the presentation of Week 12 data from its first-in-human Phase 1b/2a AMARONE trial of Restoret in patients with treatment-naïve diabetic macular edema (DME) and treatment-naïve neovascular age-related macular degeneration (NVAMD).
The analysis was presented by Charles C. Wykoff, MD, PhD, director of Research at Retina Consultants of Texas and Chairman of the Research and Clinical Trials Committee, Retina Consultants of America on February 8, 2024, at the Macula Society Meeting in Palm Springs, California.
The presentation of Week 12 data from AMARONE demonstrated that Restoret was well-tolerated, with no drug-related adverse events, drug-related serious adverse events, or intraocular inflammation reported.
Patients with DME (n=26) received Restoret as monotherapy, manifesting a mean improvement in best-corrected visual acuity of +11.2 letters and a mean reduction in retinal thickness of -143 microns, as measured by optical coherence tomography (OCT).
Similar outcomes were observed in patients with NVAMD (n=5), who received Restoret in combination with aflibercept. The data demonstrated that multiple monthly doses of Restoret, as both monotherapy and in combination with aflibercept, were well-tolerated.
“These data from AMARONE are unique and impressive,” stated Charles C. Wykoff, MD, PhD. “While anti-VEGF monotherapies have proven valuable, many patients still do not achieve optimal outcomes and there remains substantial unmet need for therapeutics with alternative mechanisms of action that can improve outcomes for patients with exudative retinal diseases including diabetic macular edema and wet macular degeneration. While early data thus far, it is exciting to see these meaningful anatomic and visual improvements using this differentiated and fascinating Wnt agonist, especially in the absence of VEGF inhibition.”
“We are thrilled to be sharing first-in-human data from the Restoret development program,” said David R. Guyer, MD, CEO of EyeBio. “The AMARONE trial represents the first ever clinical use of a Wnt pathway agonist to address retinal disease, and we are encouraged by the preliminary safety and efficacy data we’ve seen thus far.”
“Retinal diseases impact millions of people worldwide, and so we need to continue to innovate to help drive better outcomes for these patients,” said Tony Adamis, MD, chief scientific officer of EyeBio. “There is a great deal of preclinical evidence that agonizing the Wnt pathway in the retina results in reduction in vascular leakage, and so it is very gratifying to generate the first clinical evidence that validates this pathway in the eye.”