Early safety, efficacy results positive for Restoret in DME

Key Takeaways

• Patients with diabetic macular edema (DME) showed visual and anatomic improvements when treated with the investigational drug Restoret.
• Restoret was well tolerated at 12 weeks.

Despite treatment with anti-VEGF monotherapy, which targets a signal protein involved in blood vessel formation, most patients with DME have suboptimal visual gain (>60% of patients) and subsequent loss of vision over time. Many patients have persistent blood vessel leakage despite frequent delivery with the standard of care. Restoret is an investigational drug that seeks to eliminate leakage in retinal vascular diseases by restoring and maintaining the blood retinal barrier. 

Restoret showed promising safety and efficacy results at 12 weeks in 26 patients with treatment-naive DME, according to a press release from EyeBio. “Restoret has shown visual and anatomic improvements in patients with DME,” 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…” Results from the phase 1b/2a AMARONE trial were presented at the Macula Society meeting and demonstrated that Restoret (EYE103) was well tolerated, with no drug-related adverse events, drug-related serious adverse events or intraocular (within the eye)  inflammation.

Based on these results, EyeBio is beginning a Series B fundraising process and plans to move forward with a pivotal registrational trial of Restoret. For more information about this trial, visit https://clinicaltrials.gov/study/NCT05919693 or contact Keith Baker, MD, at 212-914-0127 or ClinicalInquiries@eyebiotech.com. 

Edited by Miriam Kaplan, PhD

Source: Anthony DeFino, Healio Ocular Surgery News, February 14,  2024; see source article