Why Ocular Therapeutix (OCUL) Shares Are Gaining Today - Ocular Therapeutix (NASDAQ:OCUL)

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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.

OCULOcular Therapeutix Inc

$9.39-1.16%

Overview

REGNRegeneron Pharmaceuticals Inc

$774.66-%

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

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