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EyePoint Announces Topline Data from LUGANO, the First of Two Pivotal Phase 3 Clinical Trials for DURAVYU 2.7mg in Wet AMD
EyePoint released topline Phase 3 LUGANO data for DURAVYU (vorolanib intravitreal insert) in wet AMD. Per the release, "The primary endpoint of change from baseline in best corrected visual acuity (BCVA) versus 2 mg aflibercept on-label control was not achieved in the full dataset." The release adds that DURAVYU "was non-inferior to on-label aflibercept (nominal p-value = 0.0096) in an ad hoc analysis excluding a 4% asymmetric cohort (9 of 211 patients) who experienced vision loss (>= 15 letters) unrelated to wet AMD," and reports a 42% reduction in treatment burden versus aflibercept (p-value <0.0001). The on-label 2 mg aflibercept comparator is Regeneron's Eylea; a missed head-to-head primary endpoint by the leading long-duration challenger is relevant to Regeneron's anti-VEGF franchise.
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