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Article | 2026 AAO Meeting

Tarcocimab and Tabirafusp Meet Phase 3 Endpoints

At AAO 2026, Charles C. Wykoff, MD, PhD, presented positive DAYBREAK results for both Kodiak Sciences agents. A BLA submission for tarcocimab is planned later this year.

By: Jim Gallagher, senior managing editor
Retinal Physician October 10, 2026

Clinical Scorecard: Tarcocimab and Tabirafusp-ted Meet DAYBREAK Primary Endpoints

At a Glance

CategoryDetail
ConditionClinical topic addressed by the source article: Tarcocimab and Tabirafusp Meet Phase 3 Endpoints
Key MechanismsMechanisms or clinical associations described in the source article.
Target PopulationPatients or participants described in the source article.
Care SettingDAYBREAK evaluated intravitreal treatment, with an AI algorithm detecting central macular fluid to guide retreatment.

Key Highlights

  • DAYBREAK enrolled 667 treatment-naïve patients and compared each investigational agent independently with aflibercept 2 mg.
  • At weeks 40, 44, and 48, mean BCVA gains were 7.2 ETDRS letters with tarcocimab and 7.6 with aflibercept; tarcocimab met the noninferiority endpoint (P=.0007).
  • With tarcocimab, 54% of patients reached a 24-week dosing interval, and the median number of post-loading injections was 1 versus 5 with aflibercept.
  • Tabirafusp-ted 5 mg met its primary endpoint; week-48 mean BCVA gains were 6.3 letters versus 7.6 with aflibercept, and central subfield thickness reductions were 131 μm versus 138 μm.
  • No intraocular inflammation occurred in the tarcocimab or aflibercept groups; one case occurred with tabirafusp-ted. No endophthalmitis or occlusive retinal vasculitis cases were reported.

Guideline-Based Recommendations

Diagnosis

  • DAYBREAK used an artificial intelligence algorithm to detect intraretinal and subretinal fluid within the central 3 mm of the macula.

Management

  • The trial used a treat-to-dry and maintain-dry approach, with fluid detection guiding retreatment.
  • Aflibercept 2 mg was administered every 8 weeks after 3 monthly loading doses; tabirafusp-ted 5 mg was given every 8 weeks with additional monthly treatment as indicated.

Monitoring & Follow-up

  • The primary endpoint was mean change in BCVA from baseline, averaged across weeks 40, 44, and 48.
  • DAYBREAK is continuing through week 96 to evaluate longer-term efficacy, durability, and safety.

Risks

  • One case of intraocular inflammation was reported in the tabirafusp-ted group; none were reported with tarcocimab or aflibercept.
  • No cases of endophthalmitis or occlusive retinal vasculitis were reported.

Patient & Prescribing Data

The randomized, double-masked DAYBREAK trial enrolled 667 treatment-naïve patients with nAMD.

Tarcocimab was evaluated against aflibercept 2 mg every 8 weeks after 3 monthly loading doses. With tarcocimab, 54% reached a 24-week interval and 29% received treatment at intervals of 12, 16, or 20 weeks. Tabirafusp-ted 5 mg was administered every 8 weeks, with additional monthly treatment as indicated.

Clinical Best Practices

  • DAYBREAK used central macular intraretinal and subretinal fluid detection to guide retreatment, without requiring a specified increase in central subfield thickness or loss of visual acuity.
  • The trial described its retreatment strategy as treat-to-dry and maintain-dry.
  • The article reports that longer-term efficacy, durability, and safety are being evaluated through week 96.

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