Ocular Therapeutix, Inc. (OCUL) today reported positive topline results from its pivotal Phase 3 SOL-1 trial in wet age-related macular degeneration (AMD), marking the first successful demonstration of superiority over an approved anti-VEGF therapy in an FDA-aligned study. Despite the positive results, shares are down over 27%. The company will discuss the data in detail during its investor call and webcast scheduled today 8:00 am.
The SOL-1 trial compared a single intravitreal dose of AXPAXLI (OTX-TKI), a bioresorbable hydrogel incorporating axitinib, against aflibercept (2 mg). At Week 36, 74.1% of patients in the AXPAXLI arm-maintained vision, a statistically significant improvement over aflibercept. Durability was also demonstrated at Week 52, with 65.9% of AXPAXLI-treated patients maintaining vision compared to 44.2% in the control arm. Rescue-free rates remained high, with nearly two-thirds of patients avoiding supplemental injections through Week 52.
Safety findings were favorable, with no treatment-related ocular or systemic serious adverse events observed. Investigators noted that AXPAXLI's performance suggests the potential for a reduced treatment burden, with some patients possibly requiring only annual dosing.
Executives and trial investigator described the results as a historic advance in retinal care, positioning AXPAXLI as the first therapy to achieve superiority in wet AMD under FDA's stringent evidentiary standards.
Ocular Therapeutix plans to submit a New Drug Application based on the SOL-1 data, subject to discussion with the FDA, and will present detailed findings at the upcoming Macula Society Annual Meeting.
The company recently announced financial results for the full year 2025, posting a net loss of $265.9 million, wider than $193.5 million in 2024, while revenue fell to $52.0 million from $63.7 million the prior year.
As of December 31, 2025, cash, cash equivalents, and marketable securities totaled $737.1 million, which management said is sufficient to fund operations into 2028.
OCUL has traded between $5.78 and $16.44 over the past year. The stock closed February 13, 2026, trading at $8.88, down 1.99%, and fell further in the pre-market to $6.50, down 26.83%.
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