Ocular Therapeutix Shares Jump 28% as SOL-1 Nears Key Data

Khac Phu Nguyen

Wed, February 18, 2026 at 6:59 AM GMT+9 2 min read

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OCUL

-21.28%

This article first appeared on GuruFocus.

Ocular Therapeutix (NASDAQ:OCUL) is advancing what could be a defining late-stage push with AXPAXLI, its investigational axitinib intravitreal hydrogel, as it works through multiple Phase 3 programs in wet age-related macular degeneration and diabetic retinal disease. In its latest annual filing, the company outlined ongoing registrational trials including SOL-1 and SOL-R in wet AMD and HELIOS-3 in non-proliferative diabetic retinopathy, underscoring a strategy built around durability and reduced treatment burden. Investors appeared to take notice, with shares jumping over 28% in premarket trading on Tuesday.

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The SOL-1 trial, conducted under a Special Protocol Assessment agreement with the FDA, completed randomization of 344 treatment-naive wet AMD subjects, and all participants have finished their Week 52 visits and been re-dosed according to their baseline assignment. The company plans to present 52-week data at the 49th Macula Society Annual Meeting between February 25 and 28, 2026, while continuing to follow patients through Week 104. Alongside this, SOL-R has randomized 631 subjects, surpassing its initial target, and topline results on the primary endpoint are now expected in the first quarter of 2027. Management has indicated that, pending favorable SOL-1 data and planned FDA discussions, it intends to submit a new drug application for wet AMD based on Week 52 results and pursue the Section 505(b)(2) pathway, which could shorten the review timeline by up to two months.

Beyond wet AMD, the Phase 3 HELIOS-3 trial is evaluating AXPAXLI in approximately 930 subjects with moderately severe to severe NPDR, using a novel ordinal two-step DRSS change endpoint at Week 52. Earlier Phase 1 HELIOS-1 data showed that 46.2% of treated subjects achieved a one- or two-step DRSS improvement at 48 weeks, with 23.1% reaching a two-step improvement and no worsening reported in the AXPAXLI arm. The company has suggested it may refine its diabetic retinal disease strategy depending on regulatory feedback tied to its wet AMD filing plans. With multiple late-stage readouts ahead and a potential NDA submission pathway outlined, AXPAXLI could represent a pivotal catalyst, although clinical, regulatory, and financing risks remain part of the investment equation.

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