Objective:
Report one-year results from the pivotal phase 2b/3 BRUNELLO trial of investigational remigromig for diabetic macular edema (DME).
Approach:
- Study: BRUNELLO compared remigromig 0.5 mg and 0.8 mg with monthly ranibizumab 0.5 mg in patients with DME.
- Primary endpoint: The trial assessed mean change from baseline in best-corrected visual acuity (BCVA) at one year.
Key Findings:
- Both remigromig doses independently met the primary endpoint of noninferiority to ranibizumab.
- Mean BCVA gains at one year were 9.1 letters with remigromig 0.5 mg, 8.7 letters with 0.8 mg, and 11.8 letters with ranibizumab.
- No secondary endpoint showed superiority to ranibizumab, according to Merck.
- Adverse events related to proliferative diabetic retinopathy occurred in 6.7% and 6.1% of the remigromig groups versus 0.9% with ranibizumab. Discontinuations due to adverse events were 4.9%, 4.5%, and 0.9%, respectively.
Interpretation:
Merck reported that the BCVA differences were within the prespecified noninferiority margin and were not considered clinically meaningful. The company said PDR cases were generally manageable with standard-of-care treatment and that further analyses are underway.
Limitations:
- The context does not provide the trial sample size, detailed study methods, or full safety results.
- The reported results are from a company announcement; the context does not include a full peer-reviewed publication.
Conclusion:
Merck said it will discuss BRUNELLO results with regulatory authorities. Remigromig is also being studied in the pivotal phase 2b/3 BAROLO trial in DME.
Sources:
This content is an AI-generated, fully rewritten summary based on a published scholarly article. It does not reproduce the original text and is not a substitute for the original publication. Readers are encouraged to consult the source for full context, data, and methodology.