Aldeyra announces positive FDA pre-NDA meeting for ADX-2191; NDA submission expected by end of 2022

Aldeyra Therapeutics, Inc.

Pre-NDA meeting with FDA concluded positively; NDA for ADX-2191 in primary vitreoretinal lymphoma planned as soon as end of 2022.
Company intends to request Priority Review, which would shorten FDA review to 6 months.
ADX-2191 has Orphan Drug Designation; Phase 3 GUARD Trial showed no serious adverse events and was well tolerated.
Most common adverse event was punctate keratitis, less frequent than previously reported with compounded methotrexate.
Type C meeting for proliferative vitreoretinopathy and Phase 2 retinitis pigmentosa results expected in first half of 2023.

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