Opthea (ASX:OPT) granted FDA Fast Track approval for eye disorder treatment

• Opthea (OPT) has been granted Fast Track designation for its treatment for patients with neovascular age-related macular degeneration
• The US Food and Drug Administration’s (FDA) Fast Track program advances the review of therapies for serious conditions where there is currently an unmet medical need
• Opthea is currently recruiting patients into two global, randomised phase 3 trials to assess the efficacy and safety of the treatment for the debilitating eye disease
• Opthea was up 8.33 per cent, trading at $1.37 at 12:00 pm AEST

Opthea (OPT) has been granted Fast Track designation for its treatment for patients with neovascular age-related macular degeneration.

The US Food and Drug Administration’s (FDA) Fast Track program advances the review of therapies for series conditions where there is currently an unmet medical need, in order to get new therapies to patients more quickly.

This new approval for Opthea’s VEGF-C/-D ‘trap’ inhibitor, OPT-302, in combination with anti-VEGF, is hoped to expedite the roll out of the treatment.

Thanks to the new accreditation, Opthea is now eligible for more frequent regulatory meetings and communications with the FDA, as well as reviews of completed sections of its biologic drug application.

The company says OPT-302 may also be eligible for accelerated approval and priority review if the relevant criteria is met.

Chief Executive Officer and Managing Director of Opthea, Dr Megan Baldwin, says the designation shows recognition from the FDA of the seriousness of the eye disease and the importance of advancing new therapies to treat it.

“Given the need to improve therapeutic options for wet AMD [neovascular age-related macular degeneration] 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 Dr Baldwin.

“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 is currently recruiting patients into two global, randomised phase 3 trials, known as ShORe — Study of OPT-302 in combination with Ranibizumab — and COAST — Combination OPT-302 with Aflibercept Study.

Both clinical studies will enrol around 990 patients each to assess the efficacy and safety of intravitreal 2.0 milligrams (mg) OPT-302 in combination with 0.5 mg ranibizumab or 2.0 mg aflibercept, compared to the treatments alone.

Opthea was up 8.33 per cent, trading at $1.37 at 12:00 pm AEST.