Merck's remigromig matches standard care in diabetic eye disease trial

Merck's experimental injectable therapy for diabetic macular edema (DME) has met the primary endpoint of a mid- to late-stage clinical trial, the company said on Thursday.

The 52-week study enrolled adults with the condition, in which fluid builds up and causes swelling in the macula, the central portion of the retina at the back of the eye. The disease can progress to blindness.

According to the company, remigromig proved non-inferior to ranibizumab — a standard anti-VEGF treatment — on the mean change from baseline in best-corrected visual acuity, a measure of the sharpest sight a patient can achieve with corrective lenses.

Merck described the drug as well tolerated overall, but noted that the rate of discontinuation due to adverse events was higher than in the ranibizumab arm. The company said it is still analyzing the trial data.

Remigromig is designed to repair the retina's leaky blood-vessel barrier, a mechanism intended to reduce the swelling that blurs vision. Existing options include anti-VEGF eye injections such as ranibizumab, which block or regulate the growth of blood vessels, along with laser therapy and steroid injections or implants.

"This is the first and only new mechanism of action in 20 years that has achieved Phase 3 results non-inferior to anti-VEGF therapy — representing an important milestone for patients in developing a potential new treatment," said David Guyer, chief executive of EyeBio, a wholly owned Merck subsidiary.

DME affects roughly 5.5% of people with diabetes worldwide, according to National Institutes of Health data.

Merck plans to present the full results at the annual meeting of the American Academy of Ophthalmology next month.