The Opthea Ltd (ASX: OPT) share price is soaring today, up more than 8% trading at $1.37 at the time of writing.
The clinical stage biopharmaceutical company is focused on developing therapies to treat progressive retinal diseases.
Below, we look at the company's latest update from its United States' endeavours.
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What update did Opthea announce?
Opthea's share price is rocketing after the company reported that it had received Fast Track designation from the US Food and Drug Administration (FDA) for its product to treat patients with neovascular (wet) age-related macular degeneration (AMD).
Opthea said the Fast Track designation for its VEGF-C/-D 'trap' inhibitor, OPT-302, used in combination with anti-VEGF-A therapy, recognises the potential role that OPT-302 has for addressing significant unmet needs to manage neovascular AMD.
The FDA's Fast Track designation opens the door to Opthea for improved communications with the administration. It said a rolling review process enabled by the designation will help speed up its Phase 3 development program and approval review processes.
It noted that OPT-302 may now also be eligible for accelerated approval and priority review as long as it meets the needed criteria.
Commenting on the Fast Track approval, Opthea's CEO Megan Baldwin said:
The recognition from the FDA to grant OPT-302 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 was currently recruiting patients for 2 simultaneous global Phase 3 trials, with some 990 patients expected in each.
Opthea share price snapshot
Despite today's rise, the Opthea share price remains down 45% over the past 12 months, during a period that saw the All Ordinaries Index (ASX: XAO) gain 24%.
Year-to-date, the Opthea share price has remained under pressure, down 30%.
