This marks a significant advancement in ophthalmic care, introducing the first FDA-approved ophthalmic formulation of clobetasol propionate, a corticosteroid and the first new steroid in the ophthalmic market in over one and half decades.
The approved formulation offers a simplified dosing regimen, requiring administration only twice a day for 14 days without the need for tapering.
In two Phase III clinical trials, the ophthalmic suspension demonstrated quick and lasting clearance of inflammation and pain relief that was statistically and clinically superior to a matching placebo.
This new eyedrop will enter a market valued at $1.3bn, driven by nearly seven million ocular surgeries performed per year in the US.
Formosa, with a strategic focus on ophthalmology and oncology, leveraged its APNT nanoparticle formulation platform to develop the newly approved clobetasol propionate ophthalmic suspension 0.05%.
This platform enhances the dissolution and bioavailability of active pharmaceutical ingredients (APIs), which is crucial for topical, oral, and inhaler drug delivery.
Formosa Pharmaceuticals president and CEO Erick Co said: “This approval marks Formosa Pharma’s entry into the global marketplace and provides a critical foundation and momentum for continued development, as well as advancement of new endeavours.
“With FDA approval now secured, we look forward to working with our US commercialisation partner, Eyenovia, to reach ophthalmologists and ocular surgery patients, while in parallel working to expand into additional territories and advance our earlier stage pipeline.”
In August last year, Formosa signed a licencing agreement granting sole US rights for marketing APP13007 (clobetasol propionate ophthalmic nanosuspension, 0.05%) to Eyenovia.
As per the deal, Formosa received upfront as well as development and sales-based milestone payments totalling $86m apart from other agreement considerations.