(ASX:OPT) has announced that the US FDA has granted Fast Track designation for its OPT-302 in combination with anti-VEGFA therapy for the treatment of patients with neovascular age-related macular degeneration (AMD).
The FDA’s Fast Track program offers a number of benefits to help advance development and expedite the review of novel therapies for serious conditions for which there is an unmet medical need, with the aim of getting important new therapies to patients more quickly.
The designation means Opthea is eligible for more frequent regulatory meetings and communications with the FDA and a Rolling Review of completed sections of its Biologic Drug Application (BLA), which will help expedite the Phase 3 development program and subsequent approval review process. OPT-302 may also be eligible for Accelerated Approval and Priority Review if relevant criteria are met.