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Article | 2026 AAO Meeting

Remigromig Meets Primary Endpoint in BRUNELLO Trial

Both doses of the Wnt pathway agonist met the primary noninferiority endpoint in evaluation against ranibizumab in patients with DME, Donald J. D’Amico, MD, reported at AAO.

By: Jim Gallagher, senior managing editor
Retinal Physician October 11, 2026
Objective:

Evaluate remigromig against ranibizumab for diabetic macular edema (DME), with the primary endpoint of noninferiority in best-corrected visual acuity (BCVA) change at week 52.

Approach:
  • Design: Randomized, double-masked phase 2b/3 trial enrolling 984 adults with DME.
  • Treatments: Participants received monthly intravitreal remigromig 0.5 mg, remigromig 0.8 mg, or ranibizumab 0.5 mg.
  • Mechanism: Remigromig is designed to activate the Wnt pathway by engaging FZD4 and two LRP5 epitopes, with the aim of restoring blood-retinal barrier integrity.
Key Findings:
  • Both remigromig doses met the prespecified noninferiority endpoint versus ranibizumab at week 52.
  • Mean BCVA gains were 9.1 ETDRS letters with remigromig 0.5 mg and 8.7 letters with 0.8 mg, compared with 11.8 letters with ranibizumab.
  • Neither remigromig dose was superior to ranibizumab for visual acuity or central subfield thickness.
  • PDR-related adverse events occurred in 6.7% and 6.1% of patients receiving remigromig 0.5 mg and 0.8 mg, respectively, versus 0.9% with ranibizumab.
  • Treatment discontinuation due to adverse events occurred in 4.9%, 4.5%, and 0.9% of patients, respectively. Intraocular inflammation rates were similar, and no retinal vasculitis was reported.
Interpretation:

Donald J. D’Amico said the higher rate of PDR-related events might reflect less protection against neovascular progression with remigromig than with ranibizumab. He reported that PDR cases were manageable with standard-of-care treatment and that 85% of affected patients gained vision at 1 year.

Limitations:
  • The reported results are from the 52-week primary analysis of a 2-year study; personalized treatment intervals will be evaluated in year 2.
  • The context reports results presented at a meeting and does not provide a full trial publication or detailed statistical methods.
Conclusion:

The trial met its primary noninferiority endpoint for both remigromig doses. The article reports that confirmation in the companion pivotal BAROLO trial would support further development of Wnt pathway activation for DME.

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