Ocular Therapeutix Shares Jump On Favorable Data From Intravitreal Implant Study In Wet AMD

• Ocular Therapeutix Inc (NASDAQ: 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 (NASDAQ: 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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This article Ocular Therapeutix Shares Jump On Favorable Data From Intravitreal Implant Study In Wet AMD originally appeared on Benzinga.com

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