FDA Notifies Ocular Therapeutix that SOL-R Trial is Appropriate as a Registrational Study in Wet AMD

Ocular Therapeutix announced that it has received a written response from the FDA that the phase 3 SOL-R clinical trial is appropriate for use as the company’s second adequate and well controlled study of Axpaxli (axitinib intravitreal implant, also known as OTX-TKI) for the treatment of patients with wet age-related macular degeneration (AMD).

In a Type C written response, the FDA agreed that the SOL-R repeat dosing wet AMD study is appropriate as an adequate and well-controlled study in support of a potential new drug application (NDA) and product label. The FDA also noted that the use of one superiority study and one noninferiority study is generally acceptable as the basis of an eventual NDA in wet AMD. Ocular expects the ongoing SOL-1 and SOL-R phase 3 clinical trials to form the basis for the regulatory filing of Axpaxli for wet AMD, assuming successful completion.

Ocular recently announced that the first subjects have been enrolled in the SOL-R noninferiority study evaluating repeat dosing of Axpaxli. Enrollment in the SOL-1 superiority study evaluating a single Axpaxli implant continues to accelerate, with subjects who do not meet randomization criteria having an opportunity to be enrolled into SOL-R.

“We are very pleased that the FDA has found the SOL-R repeat dosing study to be acceptable as a registrational trial of Axpaxli in wet AMD. This is an outstanding achievement for Ocular that clarifies the regulatory path for the two complementary phase 3 studies in the Axpaxli wet AMD program, SOL-1 and SOL-R,” Pravin U. Dugel, MD, Executive Chairman, President and Chief Executive Officer of Ocular Therapeutix, said in a company news release. “Our phase 3 program is designed to align with the FDA’s guidance and provide commercially meaningful data. Thanks to the efforts of our clinical team, we have accelerated enrollment in our first study, SOL-1. In addition, over a period of less than 3 months, the team was able to conceptualize SOL-R, activate clinical sites, enroll the first subjects, and has now obtained confirmatory FDA feedback regarding the registrational study. We look forward to continuing our collaboration with regulatory authorities as we work towards our goal of making Axpaxli available to people with wet AMD.”

SOL-1 is a superiority study comparing a single Axpaxli implant to a single aflibercept (2 mg) injection, after both arms receive two aflibercept (2 mg) loading doses. SOL-R compares Axpaxli dosed every 6 months (Q6M) to the current standard of care, aflibercept (2 mg) dosed every 8 weeks. A third arm evaluating 8 mg aflibercept dosed Q6M is incorporated in the SOL-R study to ensure adequate masking, following the FDA’s recommendation that sham injections do not provide complete masking and therefore may elicit potential bias.