Key takeaways:

• There were higher rates of proliferative diabetic retinopathy, vitreous hemorrhage and treatment discontinuations in those who received remigromig.
• Full 1-year results will be presented at the AAO meeting.

Editor’s note: This is a developing news story. Please check back soon for updates.

Remigromig was noninferior to ranibizumab at 52 weeks in patients with diabetic macular edema, according to a press release from Merck.

Remigromig was noninferior to ranibizumab at 52 weeks in patients with diabetic macular edema.

The investigational therapy was well tolerated, but there were “higher rates of proliferative diabetic retinopathy, vitreous hemorrhage and treatment discontinuations due to adverse events” in those who received remigromig compared with ranibizumab, according to the release.

Researchers assessed the safety and efficacy of remigromig, also known as MK-3000 and formerly known as EYE103, in the pivotal phase 2b/3 BRUNELLO trial of 984 patients with DME. Participants were randomly assigned to receive low-dose remigromig (0.5 mg), high-dose remigromig (0.8 mg) or active control (ranibizumab 0.5 mg), according to the release.

In the first year, patients received their assigned dose every 4 weeks. In the second year, treatment frequency will be adjusted based on a personalized treatment interval. The primary endpoint was mean change in best corrected visual acuity from baseline to week 52 in the study eye, according to the study.

At week 52, both doses of remigromig were noninferior to ranibizumab in mean change in BCVA based on ETDRS vision testing.

Merck will share the full 1-year results of the BRUNELLO trial at the American Academy of Ophthalmology meeting in October.

“This is the first and only new mechanism of action in 20 years that has achieved phase 3 results noninferior to anti-VEGF therapy, representing an important milestone for patients in developing a potential new treatment,” David R. Guyer, MD, CEO and president of Merck subsidiary EyeBio, said in the release. “We look forward to sharing these findings with the scientific community at AAO.”