Kodiak Sciences Inc (NASDAQ:KOD) has announced topline results from its Phase 2b/3 trial evaluating KSI-301 in treatment-naïve subjects with neovascular (wet) age-related macular degeneration.
- The trial did not meet the primary efficacy endpoint of showing non-inferior visual acuity gains for subjects dosed on extended regimens compared to Regeneron Pharmaceuticals Inc (NASDAQ:REGN) Eylea (aflibercept) given every eight weeks.
- The 559-participants study results showed that KSI-301 demonstrated strong durability and was safe and well-tolerated.
- A pre-specified secondary analysis at year 1 assessing durability showed 59% of patients in the KSI-301 arm achieved five-month dosing with visual acuity gains and anatomic improvements comparable to the overall aflibercept group.
- Related: Read Why Barclays Analyst Is 'Negatively Biased' On Kodiak Sciences.
- The Company expects that the BEACON study in retinal vein occlusion will have the primary endpoint visit completed in all patients this coming June, with topline data anticipated to follow shortly after that.
- For GLEAM and GLIMMER long-interval studies in diabetic macular edema as well as the DAYLIGHT short-interval study in wet AMD, the topline data is expected in early 2023.
- Price Action: KOD shares are down 72.20% at $14.01 during the premarket session on the last check Wednesday.
