The FDA designates Aldeyra Therapeutics' (ALDX +4%) Phase 3-stage ADX-2191 for Fast Track review for the prevention of proliferative vitreoretinopathy, a condition that can occur with a retinal tear in which scar tissue interferes with successful reattachment surgery. It occurs in 5 - 10% of retinal detachment repairs and accounts for ~75% of all primary surgical failures. The condition leads to severe vision loss and even blindness.
ADX-2191 is an intravitreal formulation of methotrexate, a chemotherapeutic agent and immune system suppressant that works by slowing or stopping the growth of cells and suppressing the immune response.
Fast Track status provides for more frequent interaction with the FDA review team and a rolling review of the marketing application.
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