Key Takeaways

  • Ocular Therapeutix has enrolled the first patient in the SOL-X extension trial to evaluate the long-term safety and durability of Axpaxli for wet AMD over an additional 3 years
  • The study builds on the SOL-1 results, with a focus on sustained VEGF suppression to maintain vision and potentially reduce fibrosis, atrophy, and treatment burden
  • Researchers aim to determine whether early and continuous treatment with Axpaxli can improve long-term outcomes and increase patient retention compared with current therapies

Ocular Therapeutix announced that the first patient has been enrolled in its SOL-X long-term extension trial evaluating Axpaxli (OTX-TKI) for the treatment of wet age-related macular degeneration (AMD).

The SOL-X study follows encouraging results from earlier trials and is designed to assess the long-term safety and durability of Axpaxli, a therapy aimed at delivering continuous vascular endothelial growth factor (VEGF) suppression. 

“The initiation of SOL-X reflects our continued outstanding execution and unwavering commitment to redefining the retina experience,” said Pravin U. Dugel, MD, Executive Chairman, President and CEO of Ocular Therapeutix. “Following the remarkable results from SOL-1, where Axpaxli demonstrated unmatched durability and sustained disease control, SOL-X is designed to extend that story into the long-term outcomes that matter most to patients and retinal specialists.”

Dr. Dugel emphasized that continuous VEGF suppression may not only help maintain vision but could also alter the progression of the disease by reducing the risk of fibrosis and atrophy—complications sometimes associated with current intermittent, or “pulsatile,” therapies. He added that earlier initiation of Axpaxli and sustained treatment over multiple years could improve long-term outcomes, lessen treatment burden, and keep more patients on therapy.

The open-label SOL-X extension trial will enroll patients who have completed 2-year follow-up periods in either the SOL-1 or SOL-R studies. Participants will be followed for an additional 3 years, allowing researchers to evaluate long-term safety and explore whether sustained disease control translates into improved visual outcomes over time.

Ocular Therapeutix believes the study could further demonstrate the importance of early and consistent treatment in preventing irreversible retinal damage. Positive results may also expand the therapy’s market potential by improving both short-term and long-term patient retention.

“In clinical practice, we see firsthand the consequences of inconsistent disease control over time, including progressive damage that can ultimately limit long-term visual outcomes,” said Dilsher S. Dhoot, MD, of California Retina Consultants. “What is particularly compelling about Axpaxli is the ability to deliver continuous, sustained VEGF suppression—something we have not achieved historically, including with currently approved short-acting therapies.”

Dr. Dhoot noted that earlier findings from the SOL-1 trial showed strong durability and disease control, and that SOL-X will provide critical insights into how those benefits hold up over several years in real-world settings.