Ocular Therapeutix enrolls first patient in SOL-X extension trial

Ocular Therapeutix Inc. (NASDAQ: OCUL) announced that the first patient has been enrolled in its SOL-X long-term extension trial for AXPAXLI, an investigational treatment for wet age-related macular degeneration.

The SOL-X trial is a 36-month open-label extension study designed to evaluate the long-term safety and efficacy of AXPAXLI in patients who completed the two-year follow-up in either the SOL-1 or SOL-R trials. The first subject enrolled in April 2026 after successfully completing the SOL-1 trial.

According to the trial protocol, participants will receive AXPAXLI injections every 24 weeks over the three-year study period, with assessments conducted at regular intervals. Additional anti-VEGF injections may be administered at investigator discretion.

The primary objectives include evaluating long-term safety, exploring visual outcomes including the incidence of fibrosis and macular atrophy, and assessing the impact of delayed AXPAXLI initiation in patients who initially received aflibercept in prior trials.

AXPAXLI is a bioresorbable intravitreal hydrogel incorporating axitinib, a tyrosine kinase inhibitor with anti-angiogenic properties. The treatment is currently being evaluated in Phase 3 trials for wet AMD and diabetic retinal disease.

Wet AMD affects approximately 1.7 million people in the United States and is characterized by abnormal blood vessel growth in the retina. Current treatments face challenges including patient discontinuation rates of up to 40% within one year and the need for frequent injections.

The company stated this information in a press release.

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