01:59 PM EDT, 08/07/2024 (MT Newswires) -- Ocular Therapeutix ( OCUL ) said Wednesday that the US Food and Drug Administration has agreed that a phase 3 repeat dosing study is appropriate as the second adequate and well-controlled study to support a potential new drug application for Axpaxli in wet age-related macular degeneration, or wet AMD.

According to Ocular, the FDA agreed in a written response that using one superiority study and one non-inferiority study should be acceptable for the company's new drug application for Axpaxli, assuming completion of the two trials.

The company said it now has a clear regulatory path for Axpaxli, or axitinib intravitreal implant, through its ongoing SOL-1 and SOL-R registration-enabling trials.

Ocular shares were up over 5% in recent trading, overcoming mixed Q2 results posted earlier Wednesday.

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