EyeBio Presents Promising Restoret Trial Results at Macula Society Meeting

New findings from the AMARONE clinical trial have shown promising results for the drug Restoret in the treatment of diabetic macular edema (DME) and neovascular age-related macular degeneration (NVAMD). The Phase 1b/2a study, which involved 26 DME patients and 5 NVAMD patients, demonstrated that Restoret was well-tolerated with no drug-related adverse events reported.

Participants with DME treated with Restoret monotherapy experienced significant improvements, with an 80% mean reduction in excess retinal thickness and an average vision gain of 11.2 letters after 12 weeks. The drug was also tested in combination with aflibercept for NVAMD patients, showing similar positive outcomes. The presentation of these results was led by Charles C. Wykoff, MD, PhD, at the Macula Society Meeting in Palm Springs, California.

Restoret is a novel Wnt pathway agonist, which works by activating the Wnt pathway to restore and maintain the blood-retinal barrier, potentially reducing leakage in vascular diseases. The drug's unique mechanism of action offers a new approach to treating exudative retinal diseases, where current anti-VEGF monotherapies have shown limitations in achieving optimal outcomes for all patients.

David R. Guyer, MD, CEO of EyeBio, expressed excitement over the first-in-human data, highlighting the potential of Restoret as a Wnt pathway agonist in addressing retinal disease. Tony Adamis, MD, Chief Scientific Officer of EyeBio, emphasized the importance of innovation in treating retinal diseases that affect millions worldwide, noting the preclinical evidence supporting the role of the Wnt pathway in reducing vascular leakage.

The AMARONE trial was a multi-center study involving an open-label multiple ascending dose safety study and a single-masked comparative safety and preliminary efficacy study. The trial's quality control and data cleaning were successfully performed, ensuring the reliability of the findings.

EyeBio, the company behind Restoret, is a clinical-stage ophthalmology biotechnology firm focused on developing new therapies for sight-threatening eye diseases. Founded by David Guyer and Tony Adamis, EyeBio has a strong leadership team with extensive experience in ophthalmology drug development and is committed to advancing a pipeline of ocular therapies.

The positive results from the AMARONE trial represent a significant step forward in the treatment of DME and NVAMD, offering hope for improved patient outcomes through the innovative use of the Wnt pathway.