Taiwan-based Formosa Pharmaceuticals and AimMax Therapeutics announced Monday that the FDA approved clobetasol propionate ophthalmic suspension 0.05% (APP13007) for post-operative inflammation and pain following ocular surgery.
Utilizing a super potent corticosteroid, clobetasol propionate ophthalmic suspension 0.05% is derived from Formosa Pharma’s proprietary APNT nanoparticle formulation platform.
The formulation represents the first FDA-approved ophthalmic clobetasol propionate product and the first new steroid in over 15 years on the ophthalmic market, offering patients a convenient and straightforward dosing regimen (twice daily for 14 days without tapering).
Two Phase 3 trials demonstrated rapid and sustained clearance of inflammation and pain relief that was statistically and clinically superior to its matching placebo.
This eyedrop enters a $1.3 billion market for topical ophthalmic ...