Ocular Therapeutix receives FDA nod for SOL-R registrational study of Axpaxli
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Ocular Therapeutix obtained FDA support to use the phase 3 SOL-R trial as the next step in the regulatory process for Axpaxli, according to a press release.
The FDA agreed in a Type C written response that the SOL-R repeat dosing study is appropriate for investigation of the axitinib intravitreal implant in patients with wet age-related macular degeneration. The FDA determined that the trial is “adequate and well-controlled” and could support a potential new drug application, according to the release.
SOL-R is a three-arm study with approximately 825 participants. One arm receives a single dose of Axpaxli on day 1 and is dosed again at week 24, a second arm receives on-label aflibercept 2 mg every 8 weeks, and a third group receives a single dose of aflibercept 8 mg on day 1 and is dosed again at week 24 to align with the subjects in the Axpaxli arm to help with masking, according to the release.
The study’s primary endpoint is noninferiority in mean best corrected visual acuity change after 1 year from baseline between the Axpaxli and on-label aflibercept arms.
“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 CEO of Ocular Therapeutix, said in the 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.”
Ocular Therapeutix plans to use data from the SOL-R and SOL-1 trials to serve as the backbone of its regulatory filing for Axpaxli in wet AMD.
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