FDA Approval For Clobetasol Propionate Eye Drop for Post-Operative Inflammation And Pain

The first new steroid to the ophthalmic sector in more than a decade: Taiwan-based Formosa Pharmaceuticals and AimMax Therapeutics (United States) announced that the U.S. Food and Drug Administration (FDA) has approved clobetasol propionate ophthalmic suspension 0.05% (APP13007), for the treatment of post-operative inflammation and pain following ocular surgery.

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Utilizing a corticosteroid, Clobetasol propionate ophthalmic suspension 0.05% is derived from Formosa Pharma’s proprietary APNT™ nanoparticle formulation platform.  This 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 clinical trials demonstrated rapid and sustained clearance of inflammation and pain relief that was statistically and clinically superior to its matching placebo (p<0.001). 

“With FDA approval now secured, we look forward to working with our U.S. commercialization partner, Eyenovia, Inc., to reach ophthalmologists and ocular surgery patients, while in parallel working to expand into additional territories and advance our earlier stage pipeline,” said Erick Co, President and CEO of Formosa Pharmaceuticals.

“We are already working diligently toward a robust launch of this differentiated and desirable product mid-year," stated Michael Rowe, Chief Executive Officer of Eyenovia.

Source: Formosa Pharmaceuticals