Kodiak’s KSI-301 Has Narrower Path Forward After Phase II/III Failure In Wet AMD

Kodiak Sciences Inc. still has options for KSI-301, but they are narrower now that the Phase IIb/III DAZZLE study in wet age-related macular degeneration (AMD) failed to meet its primary endpoint of showing non-inferior visual acuity gains for patients dosed on extended regimens compared with Regeneron Pharmaceuticals, Inc.’s Eylea (aflibercept). Now the drug’s most likely path forward is in diabetic macular edema (DME) and retinal vein occlusion (RVO), as well as potentially monthly dosing for wet AMD based on an ongoing trial.

The company announced the results of DAZZLE on 23 February, adding that the failure to meet the primary endpoint came despite the drug demonstrating strong durability and being safe and well-tolerated