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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

Clinical Scorecard: Remigromig Meets Primary Endpoint in BRUNELLO Trial

At a Glance

CategoryDetail
ConditionDiabetic macular edema (DME)
Key MechanismsRemigromig is a trispecific, tetravalent antibody designed to activate the Wnt pathway by engaging FZD4 and two LRP5 epitopes, with the intended effect of promoting endothelial tight-junction formation and restoring blood-retinal barrier integrity. Wnt signaling operates through a mechanism distinct from VEGF.
Target PopulationAdults with DME; the BRUNELLO trial enrolled 984 participants, approximately one-quarter of whom had previously received anti-VEGF therapy.
Care SettingClinical-trial evaluation of monthly intravitreal treatment for DME; BRUNELLO was a randomized, double-masked phase 2b/3 trial.

Key Highlights

  • Both remigromig doses met the week-52 primary endpoint of noninferiority to monthly ranibizumab for mean best-corrected visual acuity (BCVA) change.
  • Mean BCVA gains were 9.1 ETDRS letters with remigromig 0.5 mg, 8.7 letters with 0.8 mg, and 11.8 letters with ranibizumab.
  • Neither remigromig dose demonstrated superiority 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.
  • The study is planned for two years; its second year will evaluate personalized treatment intervals.

Guideline-Based Recommendations

Diagnosis

  • The article reports a DME treatment trial and does not provide diagnostic recommendations.

Management

  • BRUNELLO compared monthly intravitreal remigromig 0.5 mg or 0.8 mg with monthly ranibizumab 0.5 mg.
  • The article reports that PDR cases were manageable with standard-of-care treatment; it does not specify a treatment protocol.

Monitoring & Follow-up

  • The primary endpoint was mean change from baseline in BCVA at week 52; key secondary endpoints included visual acuity and central subfield thickness.
  • The trial’s second year will evaluate personalized treatment intervals.

Risks

  • PDR-related adverse events were more frequent with remigromig than with ranibizumab: 6.7% with 0.5 mg, 6.1% with 0.8 mg, and 0.9% with ranibizumab.
  • Adverse events led to treatment discontinuation in 4.9%, 4.5%, and 0.9% of patients, respectively.
  • Intraocular inflammation was reported in 1.8% with remigromig 0.5 mg, 1.5% with 0.8 mg, and 1.8% with ranibizumab; no retinal vasculitis was reported.

Patient & Prescribing Data

BRUNELLO enrolled 984 adults with DME; approximately one-quarter had previously received anti-VEGF therapy.

Participants received monthly intravitreal remigromig 0.5 mg, remigromig 0.8 mg, or ranibizumab 0.5 mg. At week 52, both remigromig doses met the prespecified noninferiority endpoint for BCVA change; the article does not provide prescribing guidance.

Clinical Best Practices

  • Both remigromig doses met the week-52 primary noninferiority endpoint versus monthly ranibizumab; neither demonstrated superiority on 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.
  • The presenter said PDR cases were manageable with standard-of-care treatment and that 85% of affected patients gained vision at one year.

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