EyeBio Announces Positive Visual, Anatomic and Safety Data from First-in-Human Ph1b/2a AMARONE Trial of Restoret
Eyebiotech 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 wet age-related macular degeneration (AMD). 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 wet AMD (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,” Dr. Wykoff said in a company news release. “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, Chief Executive Officer 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.”
About the AMARONE Clinical Trial
The Phase 1b/2a AMARONE (Anti-permeability Mechanism and Age-Related Ocular Neovascularization Evaluation) clinical trial is a multicenter two-part trial consisting of an open-label multiple ascending dose (MAD) safety study, and a single-masked comparative safety and preliminary efficacy study of intravitreal (IVT) Restoret (EYE103) in participants with diabetic macular edema (DME) and neovascular age-related macular degeneration (NVAMD).
Four increasing doses of Restoret were tested sequentially in cohorts of 3 patients each during the MAD portion, and the three highest doses were subsequently tested in a larger cohort of patients during the proof of concept portion of AMARONE. Patients with DME received intravitreal Restoret monotherapy every month for 3 months, while patients with wet AMD received Restoret in combination with aflibercept 2mg every month for 3 months. All patients were followed for 12 weeks from their first dose.
Quality control of the trial database and data cleaning were successfully performed by IDDI/EyeBio. Of note, one participant had their end of study visit erroneously substituted for their safety extension injection visit, which was corrected. Another participant’s final visual acuity measurement was felt to be erroneous by the Principal Investigator (PI) on 11/20/23 (35 letters vs. 53 letters at month 2). Because the patient had noted subjective improvement of their vision and the PI had observed clinical improvement on OCT and exam, the PI felt the recorded vision loss was not medically plausible. He brought the subject back for recheck 4 days later (after Eylea) on 11/24/23, at which time the patient’s visual acuity was restored to 59 letters. The PI corrected the final visit input to that measured on 11/24/23, which he felt was accurate and documented with a note to file.