BEDFORD, Mass. — September 15, 2026
Ocular Therapeutix, Inc. announced the successful completion of its Pre-New Drug Application (Pre-NDA) Meeting with the U.S. Food and Drug Administration (FDA) for AXPAXLI™ (OTX-TKI), the company’s investigational treatment for wet age-related macular degeneration (wet AMD). The meeting confirmed the company’s previously established regulatory strategy and supports its plan to submit an AXPAXLI NDA in the fourth quarter of 2026. The planned application will rely on Week 52 efficacy and safety data from the Phase 3 SOL-1 trial, interim safety data from the ongoing SOL-R study and additional confirmatory evidence. Ocular also plans to include patients who have received multiple AXPAXLI injections to support its application for repeat dosing. The regulatory milestone strengthens the company’s preparations for a potential 2027 launch and positions AXPAXLI as a potential first tyrosine kinase inhibitor (TKI) approved for wet AMD..
SOL-1 Data Support AXPAXLI Regulatory Strategy
The planned NDA is built around the positive Phase 3 SOL-1 superiority study, which was designed and conducted under a Special Protocol Assessment agreement with the FDA. In February 2026, SOL-1 met its pre-specified primary endpoint with high statistical significance, providing the pivotal clinical foundation for the regulatory filing. The May 2026 Type C meeting subsequently supported the use of SOL-1 Week 52 efficacy and safety results, interim SOL-R safety data and confirmatory evidence in the NDA package. The latest Pre-NDA meeting further confirmed alignment with the FDA regarding the content and format of the planned submission under the 505(b)(2) pathway. Ocular said this pathway has the potential to shorten the FDA review timeline by up to 60 days compared with the traditional 505(b)(1) route for a new molecular entity. The company remains on track to complete its interim SOL-R safety analysis before submitting the application later this year.
AXPAXLI Targets Durability in Wet AMD Treatment
AXPAXLI is a bioresorbable intravitreal hydrogel incorporating axitinib, a multi-target tyrosine kinase inhibitor with anti-angiogenic properties. The product is being developed to address treatment challenges associated with wet AMD, a retinal disease driven largely by abnormal blood-vessel growth and vascular leakage associated with VEGF signaling. Current treatment approaches generally require repeated intraocular injections, creating an ongoing burden for patients and physicians and contributing to treatment discontinuation and undertreatment. Ocular is seeking to differentiate AXPAXLI through sustained drug delivery and longer-term disease control. The company said the SOL-1 program demonstrated durability and sustained disease control, while the inclusion of multiple-injection subjects in the NDA is intended to provide regulatory support for repeat dosing. If approved, AXPAXLI could introduce a novel TKI-based approach into the wet AMD treatment landscape while leveraging Ocular’s proprietary ELUTYX™ bioresorbable hydrogel technology.
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Ocular Accelerates Commercial Readiness for Potential Launch
With the NDA submission targeted for the fourth quarter of 2026, Ocular Therapeutix is accelerating commercial readiness activities ahead of a potential 2027 AXPAXLI launch. Wet AMD affects approximately 14.8 million people globally and 1.8 million in the United States, creating a substantial market for treatments capable of maintaining visual function while reducing treatment burden. Ocular is preparing manufacturing, commercial and market-facing capabilities while continuing regulatory work on the SOL-R program. Beyond wet AMD, AXPAXLI is also being evaluated in diabetic retinal disease, including non-proliferative diabetic retinopathy. The company’s broader pipeline includes DEXTENZA, its FDA-approved ocular corticosteroid, and OTX-TIC, an investigational travoprost intracameral hydrogel that has completed Phase 2 development for open-angle glaucoma or ocular hypertension. With FDA alignment established and the AXPAXLI NDA on track for 4Q 2026, Ocular Therapeutix is moving toward a potential first-to-market TKI opportunity in wet AMD while expanding its broader retina-focused development and commercial strategy.
Source:Ocular Therapeutix, press release
