Ocular Therapeutix receives FDA nod for SOL-R registrational study of Axpaxli

New Study

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.

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.

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.

Read more: healio.com/news/ophthalmology/20240808/ocular-therapeutix-receives-fda-nod-for-solr-registrational-study-of-axpaxli?utm_source=selligent&utm_medium=email&utm_campaign=news

Source: Healio