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Ocular Therapeutix Secures FDA Special Protocol Assessment for NPDR Trial of Axpaxli

Summary by Eyewire+
Ocular Therapeutix has received written agreement from the FDA under a Special Protocol Assessment (SPA) for the registrational trial design of Axpaxli (OTX-TKI) for the treatment of nonproliferative diabetic retinopathy (NPDR). Axpaxli (OTX-TKI) is an investigational, bioresorbable intravitreal hydrogel incorporating axitinib, a small molecule, multi-target, tyrosine kinase inhibitor with anti-angiogenic properties, under development for wet AM…
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Eyewire+ broke the news in on Tuesday, August 12, 2025.
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