Ocular Therapeutix submits SPA request to FDA for OTX-TKI pivotal trial in wet AMD

OCULAR THERAPEUTIX, INC

Submitted SPA request for first of two planned pivotal trials of OTX-TKI for wet AMD.
Trial designed as superiority comparing single OTX-TKI implant vs single aflibercept injection.
Approximately 300 treatment-naïve wet AMD subjects to be enrolled.
Trial to be prospective, multi-center, randomized, parallel-group, mostly at U.S. sites.
Company believes protocol aligns with prior FDA discussions and draft guidelines.

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