Objective:

Report first-year DAYBREAK phase 3 results for tarcocimab tedromer and tabirafusp-ted in treatment-naïve neovascular age-related macular degeneration (nAMD).

Approach:

• Trial design: Randomized, double-masked trial enrolling 667 patients. Each investigational agent was evaluated independently against aflibercept 2 mg every 8 weeks after three monthly loading doses.
• Assessment: The primary endpoint was mean change in best-corrected visual acuity (BCVA) from baseline, averaged across weeks 40, 44, and 48. AI-detected retinal fluid guided retreatment; follow-up continues through week 96.

Key Findings:

• Tarcocimab produced a mean BCVA gain of 7.2 ETDRS letters versus 7.6 with aflibercept and met the noninferiority endpoint (P=.0007).
• With tarcocimab, 54% of patients reached a 24-week dosing interval; another 29% received treatment every 12, 16, or 20 weeks. Median post-loading injections were 1 with tarcocimab versus 5 with aflibercept.
• Tabirafusp-ted 5 mg met its primary endpoint: mean BCVA gains were 6.3 letters versus 7.6 with aflibercept (P=.0036). Retinal drying was noninferior, with central subfield thickness reductions of 131 μm and 138 μm, respectively (P<.0001).
• No intraocular inflammation occurred in the tarcocimab or aflibercept groups; one case occurred with tabirafusp-ted. No endophthalmitis or occlusive retinal vasculitis was reported.

Interpretation:

The reported first-year results met the primary endpoint for both investigational agents. The trial is continuing to week 96 to assess longer-term efficacy, durability, and safety.

Limitations:

• The available report presents first-year results; follow-up through week 96 is ongoing.
• The context does not provide detailed adverse-event rates beyond the specified ocular events.

Conclusion:

Kodiak Sciences plans to submit a multi-indication biologics license application for tarcocimab to the US FDA later this year, according to the presentation.

Sources:

• Article context: AAO 2026 DAYBREAK results