By Chris Wack
Ocular Therapeutix Inc. said Tuesday it saw positive interim seven-month data from its U.S. Phase 1 clinical trial evaluating OTX-TKI, its axitinib intravitreal hydrogel implant being developed for the treatment of wet age-related macular degeneration and other retinal diseases.
The biopharmaceutical company said these interim results will allow it to discuss future development plans with the U.S. Food and Drug Administration.
If the talks with the FDA go well, Ocular plans to initiate a Phase 2 clinical trial in the third quarter of 2023.
Interim data from the U.S.-based Phase 1 clinical trial showed that the single OTX-TKI implant was generally well tolerated with a favorable safety profile. There were no drug-related ocular or systemic serious adverse events observed. No subjects dropped out of either arm.
The interim results showed subjects treated with a single OTX-TKI implant demonstrated stable and sustained best corrected visual acuity and central subfield thickness at seven months. These data have not been reviewed by FDA.
The company also plans to follow subjects in the Phase 1 trial at least until their respective one-year anniversaries of initial dosing, in accordance with the clinical trial protocol. Given the potential broad applicability of OTX-TKI to other retina diseases, Ocular also plans to initiate a U.S.-based Phase 1 clinical trial to evaluate OTX-TKI for the treatment of diabetic retinopathy in the first quarter of 2023.
Write to Chris Wack at email@example.com
(END) Dow Jones Newswires