11:28 AM EDT, 08/05/2024 (MT Newswires) -- Ocugen ( OCGN ) said Monday the US Food and Drug Administration granted expanded access program authorization for OCU400 the treatment of certain patients with a genetic eye disorder, retinitis pigmentosa.

An expanded access program allows patients with unmet needs or life-threatening conditions to get treatments that are not approved by the FDA.

OCU400 is available for patients with early, intermediate to advanced retinitis pigmentosa with at least minimal retinal preservation, according to Ocugen ( OCGN ).

The company said it is currently dosing patients with OCU400 in a phase 3 clinical trial and expects approvals for its biologics license application in the US and marketing authorization application in Europe in 2026.

Shares of the company up down 2.7%.

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