FDA fast track designation for Opthea’s OPT-302

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Opthea (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.

“Given the need to improve therapeutic options for wet AMD patients, we welcome this Fast Track designation for OPT-302 and the regulatory support it provides in expediting the Phase 3 development program to advance this promising novel treatment to patients sooner,” said CEO and managing director Dr Megan Baldwin.

“The recognition from the FDA to grant OPT302 Fast Track designation reflects the seriousness of wet AMD as a debilitating eye disease and the importance of advancing new therapies such as OPT-302 to address the significant unmet medical need for wet AMD patients, many of whom experience an incomplete response to VEGF-A inhibitors despite regular, ongoing therapy. By targeting a novel mechanism of action, OPT-302 has the potential to be a truly differentiated treatment option that when used in combination offers patients improved vision outcomes over standard of care anti-VEGF-A monotherapy.”

Opthea said it is currently recruiting patients into two concurrent global, multi-centre, randomised, double-masked, sham-controlled Phase 3 trials known as ShORe (Study of OPT-302 in combination with Ranibizumab) and COAST (Combination OPT-302 with Aflibercept Study).