Merck's Ranibizumab Meets Primary Endpoint in Phase 2b/3 Diabetic Macular Edema Study
核心洞察
Merck (搜索) reported that its experimental injection Remigromig (搜索) met the main goal of a 52-week trial in 984 patients with diabetic macular edema (搜索).
The drug achieved the required standard for change in visual acuity and was non-inferior to Roche's ranibizumab, an established anti-VEGF treatment.
Remigromig (搜索) activates the Wnt pathway (搜索) to restore the retinal blood vessel lining and reduce fluid leakage, but discontinuation rates from retinal vascular complications were higher than with ranibizumab.
Merck (搜索) has reported that its experimental injection Remigromig (搜索) met the primary endpoint of a 52-week clinical trial in 984 patients with diabetic macular edema (搜索). The drug achieved the required standard for change in visual acuity and was found to be non-inferior to Roche's established treatment ranibizumab, an anti-VEGF agent that controls abnormal blood vessel growth and leakage.
Remigromig (搜索) is designed to activate the Wnt pathway (搜索), which plays a role in cell growth and repair. The approach aims to restore the protective lining of blood vessels in the retina and reduce fluid leakage into the eye. Diabetic macular edema (搜索) develops when diabetes damages retinal blood vessels, allowing fluid to accumulate in the macula and affecting central vision. Current treatment options include anti-VEGF injections, laser therapy and steroid injections or implants.
Merck (搜索) said the drug was generally tolerated, but the rate of treatment discontinuation linked to certain retinal vascular complications was higher than with ranibizumab, and the company is continuing to analyse the findings. Analyst Evan Seigerman of BMO Capital Markets said more detailed results and supporting data would be needed before the drug's commercial potential could be assessed, and noted that safety remains an important issue. Merck is also studying Remigromig (搜索) in other retinal diseases, including neovascular age-related macular degeneration (搜索), and plans to present the latest findings at the annual meeting of the American Academy of Ophthalmology next month.