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Ocular Therapeutix Receives Special Protocol Assessment Agreement From FDA for Axpaxli Trial
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Ocular Therapeutix Receives Special Protocol Assessment Agreement From FDA for Axpaxli Trial
Aug 12, 2025 5:18 AM

07:50 AM EDT, 08/12/2025 (MT Newswires) -- Ocular Therapeutix ( OCUL ) said Monday that it has received a special protocol assessment agreement from the US Food and Drug Administration for its planned clinical trial of Axpaxli in non-proliferative diabetic retinopathy, or NPDR.

"This formal agreement ensures direct FDA alignment with our proposed approach for NPDR and provides us with a clear regulatory path forward," Ocular Therapeutix ( OCUL ) Chief Executive Pravin Dugel said.

The company said it plans to provide further details on the clinical trial design and timeline on Sept. 30.

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