Aldeyra seeks FDA transfer of ADX-2191 PVRL review, withdraws SPA protocol

Aldeyra Therapeutics, Inc.

• Aldeyra asked FDA's Division of Ophthalmology to submit a jurisdiction request to OND to move the ADX-2191 IND for PVRL to the Division of Hematologic Malignancies 2.
• Company notified FDA it withdrew the Special Protocol Assessment protocol for ADX-2191 in PVRL that the Division of Ophthalmology had reviewed and agreed to.
• Aldeyra does not expect to initiate the SPA-contemplated trial while the request is pending and expects the PVRL program will need to be redesigned.
• Context: FDA issued a Complete Response Letter in June 2023 for the ADX-2191 PVRL NDA, citing lack of substantial evidence of effectiveness.
• Company warns a redesign may be larger, longer and costlier, could delay orphan drug exclusivity, shorten cash runway and require raising capital sooner.