Merck said Thursday that its experimental Remigromig diabetes eye drug met the main goal of a clinical trial involving patients with diabetic macular edema.
The injectable treatment was found to be non-inferior to Roche’s ranibizumab in improving visual sharpness over 52 weeks.
The study included 984 patients with diabetic macular edema, a diabetes-related condition that can cause swelling in the retina and blurred vision.
Researchers measured changes in visual acuity from the beginning of treatment.
How Remigromig Works
Remigromig uses a different approach from established treatments.
The experimental drug activates the Wnt pathway, a cell growth-regulating system involved in maintaining and repairing the blood-retinal barrier.
Merck says the treatment is designed to help repair the retina’s damaged blood-vessel barrier. As a result, it may reduce fluid leakage and swelling that affects vision.
If approved, remigromig could represent a new mechanism for treating retinal vascular diseases.
Scotiabank analyst Louise Chen said the drug could become the first new mechanism of action for retinal vascular diseases in more than two decades.
Safety Data Remains a Key Concern
Although Merck described remigromig as well tolerated, the trial also raised safety questions.
The company reported a higher rate of treatment discontinuation linked to certain retinal vascular complications compared with ranibizumab.
Merck said it is continuing to analyze the findings.
BMO Capital Markets analyst Evan Seigerman said investors need the complete trial results and additional supporting data to assess the drug’s commercial potential.
He also said safety would remain an important focus as more information becomes available.
What Is Diabetic Macular Edema?
Diabetic macular edema, or DME, is a complication of diabetes that affects the retina.
High blood sugar can damage small blood vessels in the retina. These damaged vessels may leak fluid into the macula.
The macula controls sharp, central vision. Therefore, swelling in this area can lead to blurred or reduced eyesight.
National Institutes of Health data estimates that about 5.5% of people with diabetes worldwide develop DME.
Current Treatments for DME
Doctors currently use several approaches to manage diabetic macular edema.
Anti-VEGF injections, including ranibizumab, are widely used. These medicines target processes involved in abnormal blood-vessel growth and leakage.
Other options include laser treatment and steroid injections or implants.
Remigromig could offer another treatment approach if future studies confirm its effectiveness and safety.
Merck Plans to Present Full Results
Merck plans to present the trial findings at the annual meeting of the American Academy of Ophthalmology next month.
The company is also studying remigromig in other retinal conditions.
The investigational drug, also known as MK-3000 and formerly EYE103, is a tetravalent, tri-specific antibody designed to activate the Wnt pathway.
Merck is studying the treatment for conditions including diabetic macular edema and neovascular age-related macular degeneration.
For now, the latest results provide evidence of comparable vision outcomes against ranibizumab. However, additional safety and clinical data will be important before regulators can assess its potential use.
