Kodiak Sciences Achieves Positive Phase III Results for Two Wet AMD Therapies
Kodiak Sciences announced that its Phase III DAYBREAK study met primary endpoints for two investigational wet age-related macular degeneration treatments, with both demonstrating statistical equivalence to the standard aflibercept therapy. One candidate, Zenkuda, showed promising durability with 54% of patients reaching six-month dosing intervals by week 48, while maintaining visual-acuity improvements comparable to aflibercept and no serious ocular inflammation cases. The company plans to submit a biologics license application for Zenkuda this year and continue Phase III testing of its other candidate in diabetic macular edema.
Kodiak Sciences tested both therapies against aflibercept, the current standard treatment for wet AMD, using a shared control arm but independent statistical frameworks for each candidate. The trial enrolled treatment-naïve patients and employed advanced imaging technology to detect minimal fluid accumulation, enabling retreatment decisions without requiring visible vision decline or specific thickness measurements. This sensitive detection method likely contributed to the frequent dosing observed in some patient subgroups.
Zenkuda's distinguishing feature was its extended dosing durability, with more than half of treated patients eventually reaching six-month treatment intervals while maintaining visual gains equivalent to aflibercept's outcomes. Safety profiles were comparable across all treatment arms, with minimal inflammation or infection events. The company has outlined a clear regulatory pathway, planning a license application submission for Zenkuda in 2026 while advancing its second candidate through additional disease indications.
These results could expand treatment options for wet AMD, a leading cause of vision loss in older adults. Patients may benefit from potentially longer intervals between injections, which could reduce treatment burden and associated healthcare visits. Broader access to effective therapies may improve visual outcomes across diverse patient populations. However, real-world efficacy, actual adoption rates, and comparative cost considerations will ultimately determine whether this advance meaningfully changes clinical practice or patient accessibility to vision-preserving care.