OPT - Opthea's OPT-302 nabs Fast Track tag in U.S. for wet AMD

Opthea (OPT) announces that the FDA has granted Fast Track designation for its VEGF-C/-D ‘trap’ inhibitor, OPT-302, in combination with anti-VEGF-A therapy for the treatment of patients with neovascular (wet) age-related macular degeneration ((AMD)).Fast Track status provides for more frequent interaction with the FDA review team and a rolling review of the marketing application. Under the Fast Track designation, OPT-302 may also be eligible for Accelerated Approval and Priority Review if relevant criteria are met. Opthea is currently recruiting patients into two concurrent Phase 3 trials known as ShORe and COAST.Both studies will enroll ~990 treatment-naive patients each and assess the efficacy and safety of intravitreal 2.0 mg OPT-302 in combination with 0.5 mg ranibizumab (Lucentis) or 2.0 mg aflibercept (Eylea), compared to ranibizumab or aflibercept monotherapy, respectively.

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Opthea’s OPT-302 nabs Fast Track tag in U.S. for wet AMD