Merck Reports Positive Phase 2b/3 DME Results for Remigromig

Clinical Scorecard: Merck Reports Positive Phase 2b/3 DME Results for Remigromig

At a Glance

Category	Detail
Condition	Clinical topic addressed by the source article: Merck Reports Positive Phase 2b/3 DME Results for Remigromig
Key Mechanisms	Remigromig is an investigational tetravalent, trispecific antibody designed to activate the Wingless-related integration site (Wnt) pathway; the company says it focuses on repair and maintenance of the blood-retinal barrier.
Target Population	Patients or participants described in the source article.
Care Setting	Pivotal Phase 2b/3 BRUNELLO trial in patients with DME; remigromig was compared with monthly 0.5 mg ranibizumab.

Key Highlights

At 1 year, both remigromig dose arms met the primary endpoint of noninferiority to ranibizumab for mean change from baseline in best corrected visual acuity (BCVA).
Mean BCVA gains were 9.1 letters with remigromig 0.5 mg, 8.7 letters with remigromig 0.8 mg, and 11.8 letters with ranibizumab.
No secondary endpoints demonstrated superiority to ranibizumab, according to the company.
Proliferative diabetic retinopathy-related adverse events occurred in 6.7% and 6.1% of the remigromig 0.5 mg and 0.8 mg groups, respectively, versus 0.9% with ranibizumab.
Discontinuations due to adverse events were reported in 4.9% and 4.5% of the remigromig groups, respectively, versus 0.9% with ranibizumab.

Guideline-Based Recommendations

Diagnosis

Management

Monitoring & Follow-up

Risks

PDR-related adverse events, including new-onset PDR, occurred more frequently in both remigromig arms than in the ranibizumab arm.
Treatment discontinuations due to adverse events were more frequent in both remigromig arms than in the ranibizumab arm.

Patient & Prescribing Data

Patients with DME in the BRUNELLO pivotal Phase 2b/3 trial.

At 1 year, mean BCVA gains were +9.1 letters with remigromig 0.5 mg (95% CI, 8.1–10.1), +8.7 letters with remigromig 0.8 mg (95% CI, 7.7–9.8), and +11.8 letters with monthly 0.5 mg ranibizumab (95% CI, 10.7–12.8). Remigromig is investigational.