EyeBio Presents Favorable Restoret Trial Results at Macula Society Meeting

The Phase 1b/2a AMARONE clinical trial's 12-week results indicate that Restoret, developed by Eyebiotech Limited, is well-tolerated in patients with diabetic macular edema (DME) and neovascular age-related macular degeneration (NVAMD). The study, which was presented by Dr. Charles C. Wykoff at the Macula Society Meeting in Palm Springs, California, showed that Restoret, a novel Wnt agonist, not only demonstrated a strong proof of concept but also provided significant visual and anatomical improvements without any drug-related adverse events.
In the trial, patients with DME who were receiving Restoret as a single treatment experienced an average reduction of 80% in excess retinal thickness and an average vision improvement of 11.2 letters after 12 weeks. The treatment also showed promising results in patients with NVAMD when used in combination with aflibercept. The findings suggest that Restoret's monthly doses were well-tolerated, whether used alone or in conjunction with aflibercept.
Dr. Wykoff highlighted the unique and impressive nature of these results, noting the unmet need for alternative therapeutics for exudative retinal diseases where current anti-VEGF monotherapies fall short. The early data from the AMARONE trial is particularly encouraging, as it shows substantial improvements without the inhibition of VEGF.
EyeBio's CEO, Dr. David R. Guyer, expressed enthusiasm for sharing the first-in-human data, emphasizing the significance of the AMARONE trial as the first clinical use of a Wnt pathway agonist for retinal diseases. The trial's preliminary safety and efficacy data are seen as a positive step forward. Dr. Tony Adamis, EyeBio's Chief Scientific Officer, also commented on the importance of innovation in treating retinal diseases, which affect millions globally. He noted that preclinical evidence supports the role of the Wnt pathway in reducing vascular leakage in the retina, and the clinical evidence from the AMARONE trial validates this pathway's potential in ophthalmology.
The AMARONE trial is a multi-center, two-part study that includes an open-label multiple ascending dose safety study and a single-masked comparative safety and preliminary efficacy study of Restoret administered intravitreally to patients with DME and NVAMD. The trial tested four increasing doses of Restoret in cohorts of three patients each, with the three highest doses further evaluated in a larger group of patients. The study involved monthly treatments for three months, followed by a 12-week observation period.
Restoret is an investigational tri-specific Wnt agonist antibody engineered to address significant medical needs in patients with back-of-the-eye diseases. It is designed to reduce vascular leakage by activating the Wnt pathway, potentially restoring and maintaining the blood-retinal barrier. Eyebiotech Limited, founded by Drs. Guyer and Adamis, is a clinical-stage biotechnology company focused on developing new therapies for sight-threatening eye diseases. The company has a strong leadership team with extensive experience in ophthalmology drug development and is advancing a pipeline of ocular therapies based on robust scientific targets and innovative approaches. EyeBio is financially supported by a group of investors, including SV Health Investors, Samsara BioCapital, Jeito Capital, MRL Ventures Fund, Bain Capital Life Sciences, Omega Funds, and Vertex Ventures HC.

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