- Ocular Therapeutix Inc OCUL announced interim 7-month data from its U.S. Phase 1 trial evaluating OTX-TKI for wet age-related macular degeneration (wet AMD) and other retinal diseases.
- Interim data showed that the single OTX-TKI implant was generally well tolerated with a favorable safety profile. No drug-related ocular or systemic serious adverse events (SAEs) were observed.
- After the mandated aflibercept injection, one SAE of endophthalmitis was observed in the OTK-TKI arm.
- Single OTX-TKI implant demonstrated stable and sustained best corrected visual acuity (BCVA) and central subfield thickness (CSFT), comparable with Regeneron Pharmaceuticals Inc's REGN Eylea (aflibercept).
- About 80% of subjects in the OTX-TKI arm were rescue-free for up to 6 months, and 73% of subjects in the OTX-TKI arm were rescue-free for up to 7 months. FDA has not reviewed these data.
- The company plans to complete its analysis, meet with the FDA to discuss potential future clinical trial requirements, and initiate a Phase 2 wet AMD trial in Q3 of 2023.
- Ocular also plans to follow subjects in the Phase 1 trial at least until their respective one-year anniversaries of initial dosing under the clinical trial protocol.
- It also plans to initiate a U.S.-based Phase 1 clinical trial to evaluate OTX-TKI for diabetic retinopathy in Q1 of 2023.
- Price Action: OCUL shares are down 7% at $4.91 on the last check Tuesday.
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