Ocular Therapeutix obtains FDA SPA modification for pivotal Phase 3 AXPAXLI wet AMD trial

OCULAR THERAPEUTIX, INC

FDA agreed to SPA modification for SOL trial evaluating AXPAXLI (axitinib intravitreal implant) for wet AMD.
Modified protocol allows enrollment of treatment-naïve subjects with visual acuity of 20/80 or better at screening.
Eligible participants must gain ≥10 ETDRS letters or achieve 20/20 vision at Day 1 after two aflibercept injections.
Trial will evaluate a single 450 µg implant of a more soluble form of axitinib for improved drug release.
Optimized implant designed to synchronize axitinib depletion with hydrogel bioresorption.

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