OPT - Opthea gains 6% after receiving FDA waiver for OPT-302 study in wet AMD

Opthea (OPT) jumps 6% premarket on receipt of an initial Pediatric Study Plan (iPSP) waiver from the FDA for its lead product candidate OPT-302, currently in Phase 3 development for the treatment of neovascular (wet) age-related macular degeneration.The receipt of the agreed iPSP waiver means the Company will not have to conduct an additional study in the pediatric population.Opthea received iPSP waiver for OPT-302 across all subsets of the pediatric population (full pediatric age group from birth to < 17 years) for wet AMD in combination with intravitreal anti-VEGF-A therapy. “The agreed iPSP waiver is an important regulatory milestone in the US that is required to be completed before Opthea is able to submit a marketing application for OPT-302 to the FDA,” commented Dr Megan Baldwin, CEO.

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Opthea gains 6% after receiving FDA waiver for OPT-302 study in wet AMD