Merck’s remigromig matches ranibizumab in diabetic eye disease trial

The experimental Wnt-pathway treatment met its non-inferiority goal in a 984-patient late-stage study, although safety signals will require further review.

Merck said its experimental eye treatment remigromig has met the main goal in a late-stage trial for diabetic macular oedema, a sight-threatening complication of diabetes that can blur central vision. According to the company, both tested doses of the tri-specific Wnt-pathway agonist matched the performance of ranibizumab on the trial’s key measure of best-corrected visual acuity after 52 weeks.

The BRUNELLO study enrolled 984 adults and compared remigromig at 0.5 mg and 0.8 mg with ranibizumab 0.5 mg, which was given monthly. Merck said the results showed non-inferiority, meaning the new treatment performed within a pre-set margin of the standard therapy rather than proving it was superior. The company presented the findings at the American Academy of Ophthalmology annual meeting in New Orleans on Friday.

Investing.com reported that patients receiving remigromig gained 9.1 letters and 8.7 letters on an eye chart at one year, depending on dose, compared with 11.8 letters for ranibizumab. Those results suggest the experimental drug delivered broadly similar vision gains, although the comparator arm showed somewhat larger improvement. Pharmacally reported that remigromig was generally well tolerated, but also that the trial recorded higher rates of proliferative diabetic retinopathy, vitreous haemorrhage and treatment discontinuations linked to adverse events in the remigromig groups than in the ranibizumab arm.

If confirmed in further analysis and eventual regulatory review, the findings could give Merck a potential new option in a market where injectable anti-vascular endothelial growth factor therapies remain a mainstay of care for diabetic macular oedema. The company said additional evaluation is under way to better understand the safety results and place the efficacy data in context.