Ocular Therapeutix, Inc. announced the completion of enrollment for the SOL-R trial, marking it as the largest retinal tyrosine kinase inhibitor (TKI) study to date. This Phase 3 registrational trial evaluates the efficacy of AXPAXLI™ in treating wet age-related macular degeneration (wet AMD), a leading cause of vision loss. The rapid enrollment underscores the strong commitment to advancing innovative treatments for retinal diseases.
SOL-R Trial Achieves Target Enrollment
The SOL-R study successfully randomized over 555 participants across approximately 100 sites in the United States, Argentina, India, and Australia. This trial compares AXPAXLI dosed every six months against the standard treatment of aflibercept administered every eight weeks. The primary goal is to demonstrate that AXPAXLI is not inferior to aflibercept in maintaining visual acuity over a 56-week period. Remarkably, the trial maintained high retention and adherence rates, critical for the reliability of the outcomes.
Strategic Pathway Towards FDA Submission
Complementing the SOL-R trial, the SOL-1 study has also completed its randomization phase, setting the stage for a comprehensive NDA submission to the FDA in the first quarter of 2026. Both trials align with FDA guidelines and hold the potential to establish AXPAXLI as a superior treatment option by offering extended dosing intervals of six to twelve months. The FDA’s positive stance on the trial designs through Special Protocol Assessments reinforces the feasibility of regulatory approval pending successful trial results.
- Evidence suggests AXPAXLI could reduce treatment frequency significantly.
- High retention rates indicate strong patient and investigator commitment.
- FDA alignment enhances the likelihood of a successful NDA submission.
- Potential to establish a new standard of care in wet AMD treatment.
- Global trial sites reflect diverse patient demographics, strengthening data robustness.
The completion of enrollment in both SOL-R and SOL-1 trials highlights Ocular Therapeutix’s strategic execution and dedication to addressing unmet needs in retinal disease treatment. By focusing on durable and less burdensome treatment options, AXPAXLI aims to improve long-term outcomes for patients suffering from wet AMD.
Pending the favorable outcomes of these trials, Ocular Therapeutix is positioned to submit a New Drug Application to the FDA, seeking approval for AXPAXLI as a transformative treatment for wet AMD. The company’s proactive approach in trial design and execution, coupled with strong regulatory alignment, sets a promising trajectory for the introduction of AXPAXLI into the market.
The advancement of AXPAXLI through these robust clinical trials not only signifies a potential breakthrough in wet AMD treatment but also reinforces Ocular Therapeutix’s role as a leader in retinal disease innovation. Patients may soon benefit from a treatment that reduces the frequency of injections, enhancing their quality of life and adherence to therapy.
Introducing AXPAXLI could reshape the therapeutic landscape for wet AMD, offering a more convenient and potentially more effective alternative to existing treatments. This development is poised to significantly impact both patient care standards and the biopharmaceutical market dynamics in ophthalmology.
This article has been prepared with the assistance of AI and reviewed by an editor. For more details, please refer to our Terms and Conditions. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author.
