Ocular Therapeutix, Inc.

Biotechnology • Healthcare • Bedford, MA, United States • OCUL (NGM)

781 357 4000 15 Crosby Drive, Bedford, MA 01730, United States

Quarter: Q4 2025 Reported: December 18, 2025 Sentiment: Positive

Ocular Therapeutix, Inc., a biopharmaceutical company, engages in the development and commercialization of therapies for retinal diseases and other eye conditions using its bioresorbable hydrogel-based formulation technology in the United States. The company markets DEXTENZA, a dexamethasone ophthalmic insert to treat post-surgical ocular inflammation and pain following ophthalmic surgery, as well as allergic conjunctivitis. It is also developing AXPAXLI, an axitinib intravitreal hydrogel that is in phase 3 clinical trials for the treatment of wet age-related macular degeneration and in Phase 1 clinical trials for the treatment of non-proliferative diabetic retinopathy; PAXTRAVA, a travoprost intracameral hydrogel, which is in phase 2 clinical trials for the treatment of open-angle glaucoma or ocular hypertension. The company has a license agreement and collaboration with AffaMed Therapeutics Limited for the development and commercialization of DEXTENZA and PAXTRAVA. Ocular Therapeutix, Inc. was incorporated in 2006 and is headquartered in Bedford, Massachusetts.

Analysis Summary

Ocular Therapeutix, Inc. (OCUL) has unveiled a pivotal shift in its regulatory strategy for AXPAXLI (OTX-TKI), its investigational therapy for wet age-related macular degeneration (wet AMD). Historically, the FDA has mandated two adequate and well-controlled clinical trials for ophthalmic product candidates targeting large indications like wet AMD. However, in light of recent public statements from FDA leadership and subsequent direct engagements with the FDA's Division of Ophthalmology, Ocular Therapeutix now plans to submit a New Drug Application (NDA) for AXPAXLI based on Year 1 data from its ongoing SOL-1 Phase 3 clinical trial, provided the data are positive. This decision bypasses the need to await additional clinical data from SOL-1, SOL-R, or other trials, indicating a potential significant acceleration of the approval timeline.

Management commentary suggests confidence in this expedited pathway, driven by the evolving regulatory landscape and constructive dialogue with the FDA. The company expects to report top-line data from Year 1 of the SOL-1 clinical trial during the first quarter of 2026, which will be a critical catalyst for the NDA submission. This strategic initiative aims to reduce the time and cost associated with bringing AXPAXLI to market, positioning it as a potentially disruptive long-acting treatment option for wet AMD.

Competitive positioning is enhanced by the prospect of an accelerated approval, potentially allowing AXPAXLI to enter the market sooner than competitors requiring more extensive trial data. However, the company acknowledges inherent risks, including the FDA's final agreement on the interpretation of Special Protocol Assessments, acceptance of a single pivotal trial for approval, and the sufficiency of the data to demonstrate safety and efficacy. The company also highlights uncertainties regarding the registrational pathway, potential label restrictions, and the predictive value of interim data. Despite these risks, the proactive engagement with the FDA and the clear timeline for data readout in Q1 2026 underscore a positive outlook for the program's progression.

Key Highlights

• OCUL intends to submit an NDA for AXPAXLI (wet AMD) based on Year 1 SOL-1 Phase 3 trial data.
• This strategy change follows recent FDA statements and company interactions, potentially accelerating approval.
• Historically, two pivotal trials were required for wet AMD; this new approach may allow a single trial submission.
• Top-line data from Year 1 of the SOL-1 clinical trial is expected in Q1 2026.
• The company plans further engagement with the FDA regarding the regulatory pathway for AXPAXLI.

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Stock Performance (90 Days)

Data through Dec 29, 2025

Layoff Events

Earnings Calls

Positive Signals

• FDA's recent public statements indicate a potential shift in regulatory requirements for ophthalmic products.
• Direct interactions with the FDA's Division of Ophthalmology support the company's interpretation of this shift.
• Intent to submit NDA based on a single pivotal trial (SOL-1 Year 1 data) could significantly accelerate market entry.
• Clear timeline for top-line data from SOL-1 in Q1 2026 provides a near-term catalyst.

Risks & Concerns

— FDA may not agree with the company's interpretation of Special Protocol Assessments or accept an NDA based on a single pivotal clinical trial.
— Even if data is positive, the FDA may not find it sufficient to demonstrate safety and efficacy for marketing approval.
— Uncertainty regarding FDA agreement on trial design, protocol, statistical analysis, or the registrational pathway for AXPAXLI.
— Uncertainty regarding the ability to satisfy other FDA requirements for regulatory approval or potential label restrictions.
— Risk that preliminary or interim data from clinical trials may not be predictive of final data.