other material
confidence high
sentiment positive
materiality 0.75
Ocular Therapeutix initiates first pivotal trial of OTX-TKI for wet AMD
OCULAR THERAPEUTIX, INC
- Activated first US clinical trial site; expects to enroll first subject by year-end 2023.
- Superiority trial of ~300 evaluable treatment-naïve wet AMD subjects randomized to aflibercept or OTX-TKI implant.
- Filed Special Protocol Assessment request with FDA for trial design; enrollment will wait for SPA feedback.
- OTX-TKI is an axitinib intravitreal implant, a potential long-acting therapy for wet AMD.