More than 300 patients assigned to treatment in phase 3 trial of Axpaxli for wet AMD
Ocular Therapeutix announced that more than 300 patients have been randomly assigned in the SOL-1 phase 3 trial for Axpaxli, an investigational axitinib intravitreal implant for wet age-related macular degeneration.
“SOL-1 is an important trial for patients and the retina community as there is an urgent unmet need for durable therapies capable of maintaining visual acuity and improving long-term outcomes,” Pravin U. Dugel, MD, Ocular’s executive chairman, president and CEO, said in a company press release. “Today’s milestone brings us one step closer to our goal of delivering the first wet AMD therapy potentially capable of being dosed as infrequently as every 6 to 9 months.”
According to the release, Axpaxli is a bioresorbable hydrogel implant containing the tyrosine kinase inhibitor axitinib and is being evaluated for the treatment of retinal diseases, including wet AMD and diabetic retinopathy. The SOL-1 study will evaluate the safety and efficacy of the treatment for wet AMD after 9 months of treatment.
Participants in the SOL-1 trial can be directly enrolled into SOL-R, the company’s second registrational clinical trial with repeat dosing. All trial sites are now enrolling patients in SOL-R.
“Thanks to the palpable enthusiasm from the investigators and study site teams, we continue to make excellent progress with the enrollment of SOL-R, with a steady focus on our overall mission of improving vision for patients,” Dugel said in the release.
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