Merck says remigromig met BRUNELLO vision endpoint, flags eye risks

A pivotal vision result gives a new diabetic eye drug a route to regulatory talks as Merck & Co., Inc. NYSEMRK said Thursday that both remigromig doses met BRUNELLO's noninferiority goal against ranibizumab. The Sept. 24 release also flagged more eye complications and adverse event discontinuations in the 984-patient trial.

Merck did not disclose the mean gain in vision chart letters for either dose or for the control group. It also withheld the differences between arms, confidence intervals, noninferiority margin and event rates, leaving the size of the benefit and safety gap unknown until more data appear.

Merck is a large New Jersey drugmaker with marketed medicines and vaccines and a retinal program through its EyeBio subsidiary. The company scheduled a BRUNELLO presentation for Oct. 10 and said it would discuss the findings with regulators, without setting a filing date.

Merck's NYSEMRK shares closed at US$148.08 at 4:03:10 p.m. EDT Wednesday in New York, before Thursday's announcement.

Merck's Sept. 24 release says 984 adults with diabetic macular edema were randomized equally across three arms. They received intravitreal remigromig at 0.5 mg or 0.8 mg, or ranibizumab at 0.5 mg, every four weeks during the first year.

The primary measure was mean change from baseline in best-corrected visual acuity at Week 52, measured on a standard eye chart. Both remigromig doses met the noninferiority goal against the active control, Merck said, but it did not report a p value or confidence interval. Merck describes remigromig as an antibody designed to activate the Wnt pathway involved in maintaining the blood-retinal barrier. The release reported no superiority result.

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Safety Rates Remain Unreported

Merck described both doses as generally well tolerated, but reported higher rates of proliferative diabetic retinopathy, vitreous hemorrhage and treatment discontinuations due to adverse events than with ranibizumab. It did not publish counts or percentages by arm, which limits any comparison of the eye risks with the vision result.

Merck's Sept. 24 release did not report FDA feedback on BRUNELLO's noninferiority design. Merck said further analyses of the safety findings are underway and named BAROLO as a second ongoing pivotal diabetic macular edema study.

"We look forward to advancing remigromig in diabetic macular edema, a leading cause of vision loss for people with diabetes, with the hope of offering a new treatment option with the first novel mechanism of action for retinal vascular diseases in more than two decades."

Merck Research Laboratories president Dean Y. Li said in the Sept. 24 release.

Merck's June 30 quarterly filing reported US$6.849 billion in cash and cash equivalents.

Approved Rivals Set a Dosing Bar

Regeneron Pharmaceuticals, Inc. NASDAQREGN said in an April 2 release that the FDA had extended Eylea HD's approved dosing interval for diabetic macular edema to as long as 20 weeks after a year of successful response. BRUNELLO used monthly injections in its first year, with personalized intervals planned for its second.

Roche SWXRO OTCMKTSRHHBY said in its July 17, 2024, release that nearly 80 per cent of people in an exploratory long-term analysis were receiving Vabysmo every three or four months after four years. Those separate studies do not establish which treatment offers the better balance of vision benefit, injection burden and safety.

The sector price comparison is from Sept. 22, ahead of Thursday's readout. At 4:00:01 p.m. EDT, iShares Biotechnology ETF NASDAQIBB closed at US$210.81 on Nasdaq.

Merck plans to present BRUNELLO's year-one results on Oct. 10 at the American Academy of Ophthalmology meeting. That meeting is the next dated opportunity to see whether Merck discloses the missing vision and eye-event figures.