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Diabetic Macular Edema

All articles tagged with #diabetic macular edema

Merck’s $3B Eye Drug Hits Primary Goal but Raises Safety Concerns

Merck’s $3B Eye Drug Hits Primary Goal but Raises Safety Concerns

Merck & Co. reported that its trispecific drug remigromig met its primary endpoint in the Brunello phase 2b/3 trial for diabetic macular edema (DME). The drug, acquired from EyeBio in a deal valued at up to $3 billion, demonstrated non-inferiority to the standard VEGF inhibitor ranibizumab at Week 52. While the results support the hypothesis that targeting the Wnt signaling pathway can improve visual outcomes, the trial revealed higher rates of adverse events, including proliferative diabetic retinopathy and vitreous hemorrhage, compared to the control. Merck plans to present these data at the American Academy of Ophthalmology Annual Meeting next month and is conducting further analyses to characterize the safety findings. A second trial for DME is ongoing and scheduled for primary completion in March 2027. The company is positioning remigromig as a complementary therapy for patients who do not respond to existing VEGF inhibitors, aiming to diversify its pipeline beyond Keytruda.

healthcare3 years ago

Kodiak Sciences Abandons Eye Drug Development, Stock Plummets

Kodiak Sciences Inc has decided to discontinue the development of its experimental drug, tarcocimab tedromer, for the treatment of diabetic macular edema. The decision was made after the drug failed to meet its main goal in two late-stage studies and was found to cause an increase in cataracts over time in patients. As a result, the company's shares tumbled 40% in premarket trading.

Regeneron faces FDA rejection and stock slump over manufacturing and contractor issues.
healthcare3 years ago

Regeneron faces FDA rejection and stock slump over manufacturing and contractor issues.

The FDA rejected Regeneron's new 8-mg version of Eylea due to an ongoing review of inspection findings at a third-party filler, dealing a major blow to the company's attempt to expand the use of its eye injection for the treatment of patients with wet age-related macular degeneration, diabetic macular edema, and diabetic retinopathy. The company had sought to speed up the FDA's review of this application with a priority review voucher, which typically costs about $100 million.