Particle.news
Download on the App Store

Kodiak’s Zenkuda Hits Phase 3 Goal in Diabetic Retinopathy Prompting Faster FDA Filing

The results give Kodiak a clear path to a faster FDA filing.

Overview

  • Kodiak Sciences, which reported the Phase 3 GLOW2 results on Thursday, said 62.5% of Zenkuda patients achieved a two-step or greater DRSS improvement at Week 48 versus 3.3% on sham.
  • Zenkuda cut prespecified sight‑threatening complications by about 85% through Week 48, with events in 2.4% of treated patients compared with 15.8% on sham.
  • Investigators reported no intraocular inflammation or retinal vasculitis in the study, and overall eye side effects stayed low.
  • Outcomes were similar in patients using GLP‑1 diabetes drugs, suggesting the benefit holds in a real‑world population.
  • Kodiak plans to accelerate its FDA Biologics License Application next, and the stock hit a 52‑week high near $34.63 after the update as some firms reiterated Buy ratings.