(RTTNews) - Ocular Therapeutix, Inc. (OCUL), an integrated biopharmaceutical company focused on redefining treatment for retinal diseases, reported its fourth-quarter and full-year 2025 financial results and outlined several major clinical and regulatory events expected in the coming months.
The company's lead program is AXPAXLI (OTX-TKI), an investigational intravitreal hydrogel formulation of axitinib being developed for wet age-related macular degeneration (wet AMD) and diabetic retinal disease. Ocular is advancing multiple late-stage trials designed to support potential regulatory filings and broad clinical adoption.
Topline results from SOL-1, the company's Phase 3 superiority trial in wet AMD, remain masked but are expected to be presented at the 49th Macula Society Annual Meeting, taking place between February 25 - 28, 2026. The study is being conducted under a Special Protocol Assessment and, if positive, could support an NDA submission based on Week 52 data alone. Ocular has stated that it intends to pursue the 505(b)(2) pathway, which may shorten the review timeline.
The company also completed randomization of 631 subjects in SOL-R, its Phase 3 non-inferiority trial, in December 2025. With randomization exceeding the original target, Ocular now anticipates topline SOL-R data in 1Q 2027, earlier than previously expected. In addition, the SOL-X open-label extension trial is expected to begin in 2Q 2026, offering long-term safety and durability insights for patients completing SOL-1 or SOL-R.
Beyond wet AMD, Ocular is progressing HELIOS-3, a Phase 3 trial in non-proliferative diabetic retinopathy (NPDR), with randomization underway. Depending on upcoming FDA discussions, the company may streamline development in diabetic retinal disease by advancing with a single Phase 3 trial.
Ocular ended 2025 with a strong cash position. The company reported $737.1 million in cash and cash equivalents as of December 31, 2025, providing runway into 2028.
The company has one marketed product, DEXTENZA, a corticosteroid intracanalicular insert for the treatment of post-surgical ocular inflammation and pain, and ocular itching associated with allergic conjunctivitis.
Total net revenue for the fourth quarter of 2025 was $13.3 million compared to $17.1 million in the prior-year period, reflecting reimbursement challenges for DEXTENZA despite record annual unit volume.
Ocular reported a net loss of $64.7 million, or $0.29 per share, for the quarter, compared to a net loss of $48.4 million, or $0.29 per share, in the year-ago-quarter.
Research and development expenses rose to $50.8 million in Q4, compared to $41.0 million in the year-ago quarter.
Selling and marketing expenses increased to $13.0 million compared to $10.8 million in the year ago quarter.
For the full year 2025, the company recorded $52.0 million in total net revenue, compared to $63.7 million in 2024.
The net loss widened to $265.9 million, or $1.42 per share, in full year 2025, from $193.5 million, or $1.22 per share in 2024.
Outstanding shares as of February 2, 2026, were approximately 217.7 million.
OCUL has traded between $5.78 and $16.44 over the past year. The stock is currently trading in the pre-market at $9.02, up 5.50%.
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