Kodiak Sciences' Eylea challenger misses Ph II/III goal

US ophthalmic therapy developer Kodiak Sciences (Nasdaq: KOD), which had hoped to challenge the highly successful eye drug Eylea (aflibercept) and the current standard of care, saw its shares plunge 80% to $10.07 by mid-morning today, when it released top-line results from its randomized, double-masked, active comparator-controlled Phase IIb/III clinical trial evaluating the efficacy, durability and safety of KSI-301, a novel antibody biopolymer conjugate, in treatment-naïve subjects with neovascular (wet) age-related macular degeneration.

While the results show that KSI-301 demonstrated strong durability and was safe and well tolerated, it did not meet the primary efficacy endpoint of showing non-inferior visual acuity gains for subjects dosed on extended regimens compared to aflibercept given every eight weeks.

Eylea, developed by US biotech Regeneron Pharmaceuticals (Nasdaq: REGN) and licensed to German pharma major Bayer (BAYN: DE), generated US net sales of $5.79 billion in 2021, up 17% year-on-year.