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BEDFORD, Mass. - Ocular Therapeutix, Inc. (NASDAQ:OCUL), whose stock has surged over 70% in the past six months according to InvestingPro data, reported Tuesday that its SOL-1 clinical trial for wet age-related macular degeneration (AMD) continues to show high patient retention and protocol adherence, with topline data expected in the first quarter of 2026.
The company said the trial has maintained over 95% of randomized subjects on-study to date, with no new or unexpected safety signals observed. The SOL-1 trial is evaluating AXPAXLI, an investigational bioresorbable intravitreal hydrogel incorporating axitinib, against aflibercept. While the company maintains strong liquidity with a current ratio of 10.09, InvestingPro data shows it is not yet profitable, with analysts expecting continued losses this year.
Ocular also announced plans to initiate two Phase 3 registrational trials, HELIOS-2 and HELIOS-3, to evaluate AXPAXLI in non-proliferative diabetic retinopathy (NPDR). The company has secured a Special Protocol Assessment agreement with the FDA for HELIOS-2, which will utilize a novel ordinal endpoint measuring diabetic retinopathy severity score changes.
"We are especially thrilled to unveil our plans for diabetic retinopathy with our HELIOS-2 and HELIOS-3 registrational trials," said Pravin U. Dugel, Executive Chairman, President and CEO of Ocular Therapeutix. "We have designed these trials to include a novel primary endpoint that we believe has the highest probability of success."
The company’s second Phase 3 wet AMD trial, SOL-R, is on track to deliver topline data in the first half of 2027. Ocular also outlined plans for SOL-X, an open-label extension study that will evaluate AXPAXLI’s potential to improve long-term outcomes for wet AMD patients who complete the SOL-1 or SOL-R trials.
The company believes AXPAXLI could potentially receive the first superiority label compared to aflibercept in wet AMD, if approved. The information was disclosed during the company’s Investor Day presentation, according to a press release. Analysts maintain a bullish outlook, with InvestingPro showing price targets ranging from $14 to $22, though investors should note that 3 analysts have recently revised their earnings expectations downward. For deeper insights into OCUL’s financial health and growth prospects, access the comprehensive Pro Research Report, available exclusively on InvestingPro.
In other recent news, Ocular Therapeutix reported its second-quarter 2025 financial results, revealing $13.5 million in revenue, which was slightly below the expected $13.6 million but exceeded Raymond James’ estimate of $12.0 million. The company’s expenses were $51.1 million, surpassing the anticipated $43.1 million, and it posted a diluted earnings per share loss of $(0.39), marginally worse than the projected $(0.37) loss. Despite these figures, Raymond James reiterated a Strong Buy rating with a $19.00 price target, and Clear Street maintained a Buy rating with an $18.00 price target. In addition, Chardan Capital Markets initiated coverage on Ocular Therapeutix with a Buy rating and a $21.00 price target, citing the company’s Axpaxli (OTX-TKI) product. The company also secured a Special Protocol Assessment agreement from the FDA for its diabetic retinopathy trial, aligning with its proposed trial design and primary endpoint. Furthermore, TD Cowen reiterated a Buy rating with a $14.00 price target, as Ocular Therapeutix awaits Phase III trial results expected in Q1 2026. These developments reflect ongoing interest and support from various analysts for Ocular Therapeutix’s future prospects.
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