Early safety, efficacy results positive for Restoret in DME, wet AMD
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Key takeaways:
- Restoret was well tolerated as a monotherapy and in combination with aflibercept at 12 weeks.
- Best corrected visual acuity improved while retinal thickness decreased.
Restoret showed promising safety and efficacy results at 12 weeks in patients with treatment-naive diabetic macular edema and treatment-naive neovascular age-related macular degeneration, according to a press release from EyeBio.
“Restoret has shown visual and anatomic improvements in patients with DME and NVAMD,” David R. Guyer, MD, CEO of EyeBio, told Healio. “What is most unique is that Restoret works by a completely novel mechanism of action that has not been tested in the eye before. This allows for product differentiation compared to anti-VEGF standard of care both as a monotherapy and combination therapy.”
Results from the phase 1b/2a AMARONE trial were presented at the Macula Society meeting and demonstrated that Restoret (EYE103), an investigational tri-specific Wnt agonist antibody, was well tolerated, with no drug-related adverse events, drug-related serious adverse events or intraocular inflammation. Multiple monthly doses were well tolerated as a monotherapy and in combination with aflibercept.
In addition, Restoret monotherapy showed a mean improvement in best corrected visual acuity of 11.2 letters and a mean reduction in retinal thickness of 143 µm in 26 patients with DME. Results were similar in five patients with neovascular AMD treated with a combination of Restoret and aflibercept.
“Restoret represents a frameshift in our understanding of how to approach treatment of retinal vascular disease as it works through an entirely novel mechanism of action,” Guyer said. “Four decades of preclinical science supports targeting the Wnt pathway in exudative retinal diseases such as DME and NVAMD, which impact millions of patients around the world. The data from AMARONE clinically validate the basic science and confirm that Wnt is a clinical target worth pursuing. We are currently beginning a Series B fundraising process and plan to move forward with a pivotal registrational trial of Restoret.”
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