- Ocular Therapeutix Inc OCUL announced interim 10-month data from its U.S. Phase 1 trial of OTX-TKI, axitinib intravitreal hydrogel implant for wet age-related macular degeneration (wet AMD), diabetic retinopathy and other retinal diseases.
- The trial enrolled 21 subjects. OTX-TKI continued to be generally well tolerated with no drug-related serious adverse events through Month 10.
- As the company previously announced at the 7-month readout, one SAE of endophthalmitis was observed in the OTK-TKI arm following the mandated Regeneron Pharmacueticals Inc's REGN Eylea (aflibercept) injection at Month 1.
- There were no elevated IOP, retinal detachment, retinal vasculitis, or implant migration into the anterior chamber adverse events observed in the OTX-TKI arm, and no subjects had dropped out of either arm as of the data cutoff.
- The interim results exhibited that subjects treated with a single OTX-TKI implant demonstrated stable and sustained BCVA (mean change from baseline of -0.3 letters) and CSFT (mean change from baseline of -1.3 µm).
- The data was comparable with the aflibercept arm (mean change from BCVA baseline of -0.8 letters; mean change from CSFT baseline of -4.5 µm).
- All OTX-TKI treated subjects who were rescue-free at the Month 7 interim analysis remained rescue-free, extending the 73% rescue-free rate up to Month 10.
- Overall, a 92% reduction in treatment burden was observed in OTX-TKI-treated subjects for up to 10 months.
- The company plans to meet with the FDA to discuss future trial requirements.
- Subject to those discussions and obtaining the necessary financing, which could be provided through a strategic alliance, the company intends to initiate a pivotal trial in wet AMD in Q3 of 2023.
- Price Action: OCUL shares are up 15.25% at $4.46 during the premarket session on the last check Monday.
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