On Friday, Ocular Therapeutix (NASDAQ:OCUL) maintained its Buy rating and $14.00 price target from H.C. Wainwright. The reaffirmation follows the company's recent Investor Day event, where significant progress was reported on its pivotal SOL-1 trial for AXPAXLI, a treatment for wet Age-related Macular Degeneration (AMD (NASDAQ:AMD)).
During the Investor Day, Ocular Therapeutix announced that the SOL-1 trial has reached the halfway mark in enrollment, with 151 subjects now participating across 60 active study sites. The trial aims to enroll a total of 300 treatment-naïve patients. The SOL-1 study, a superiority trial without sham injections, requires subjects to have a visual acuity of 20/20 or a minimum 10-letter gain at Day 1 post-screening to be eligible for randomization.
Patients in the trial are randomized 1:1 to receive either a single AXPAXLI implant or a single aflibercept injection. The primary endpoint of the study is to maintain visual acuity, with subjects aiming to experience less than 15 ETDRS letters of Best Corrected Visual Acuity (BCVA) loss at Week 36. In cases where pre-specified rescue criteria are met, subjects may receive a supplemental dose of aflibercept.
The SOL-1 trial is being conducted under a Special Protocol Assessment (SPA) agreement with the FDA, which, according to H.C. Wainwright, significantly reduces regulatory risk for the trial. With this in mind, the firm has reiterated its confidence in Ocular Therapeutix with a Buy rating and a $14 price target.
In other recent news, Ocular Therapeutix has announced a workforce reduction, primarily affecting its research and development and technical operations departments, to focus on the clinical development of AXPAXLI™, a treatment for wet age-related macular degeneration. The restructuring is expected to be completed within the second quarter of 2024, with estimated costs ranging from $1.0 to $2.0 million.
In the financial realm, Ocular Therapeutix reported Q1 2024 revenues of $14.8 million, a 10.5% year-over-year increase, and a net loss of $64.8 million due to one-time expenses. Analysts from H.C. Wainwright and TD Cowen have revised their stock price targets for the company to $14 and $7, respectively, while maintaining their respective Buy and Hold ratings. The company also announced the appointment of Dr. Pravin U. Dugel as its President and Chief Executive Officer, a move that is expected to guide Ocular Therapeutix in its competitive landscape of eye care treatments.
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