Merck said on Thursday its Remigromig, an injectable drug for a serious eye disease affecting people with diabetes, was as effective as the current standard treatment in improving visual sharpness in a clinical trial.
In the 52-week study with 984 diabetic macular edema patients, the experimental treatment, remigromig, was non-inferior to Roche’s ranibizumab for mean change from baseline in a test measuring vision while using proper corrective lenses.
Remigromig activates a cell growth-regulating system called the Wnt pathway to help repair the retina’s leaky blood-vessel barrier and reduce swelling that blurs vision in patients with the condition.
“If approved, remigromig would be the first novel mechanism of action for retinal vascular diseases in more than two decades,” said Scotiabank analyst Louise Chen.
The results also build on Merck’s ophthalmology pipeline, which could become an important therapeutic area for the company, analysts said.
Merck’s shares climbed 1.7% in morning trading.
‘MORE INFO NEEDED ON SAFETY CONCERNS’
Merck said remigromig was well tolerated, although the rate of discontinuation due to certain retinal vascular complications was higher than that with ranibizumab. The company is analyzing the findings.
BMO Capital Markets analyst Evan Seigerman said the full trial results and supportive data are required before assessing remigromig’s commercial potential.
“Safety remains a focus into the full data with more color needed on the imbalances noted in today’s release,” Seigerman said.
Diabetic macular edema is a complication of diabetes in which damaged blood vessels in the retina leak fluid into the macula, the part of the eye responsible for sharp, central vision, causing swelling and blurred or reduced vision.
Roughly 5.5% of all people with diabetes worldwide are affected by DME, according to National Institutes of Health data.
Common treatments include anti-VEGF eye injections like ranibizumab, which block or regulate the formation and growth of blood vessels, laser therapy and steroid injections or implants.
Merck will present the results at the annual meeting of the American Academy of Ophthalmology next month.
About Remigromig
Remigromig (MK-3000, formerly EYE103) is an investigational, potentially first-in-class tetravalent, tri-specific antibody designed to activate the Wingless-related integration site (Wnt) pathway, which is involved in the repair and maintenance of the blood-retinal-barrier. Remigromig is being studied in patients with certain retinal diseases including diabetic macular edema (DME) and neovascular age-related macular degeneration (NVAMD). Remigromig is administered by intravitreal injection.
