FDA approves APP 13007 (clobetasol propionate ophthalmic suspension 0.05%) for post operative inflammation and pain following ocular surgery – Eyenovia

The FDA has approved clobetasol propionate ophthalmic suspension 0.05% (APP 13007) by Taiwan-based Formosa Pharmaceuticals and AimMax Therapeutics. This suspension for the treatment of post-operative inflammation and pain following ocular surgery is the first FDA-approved ophthalmic clobetasol propionate product and first new steroid on the US ophthalmic market in over 15 years.

The corticosteroid, clobetasol propionate ophthalmic suspension 0.05% is derived from Formosa Pharma’s proprietary APNT nanoparticle formulation platform. In Phase III clinical trials, the eyedrops demonstrated rapid and sustained clearance of inflammation and pain relief that was statistically and clinically superior to its matching placebo (p<0.001). The suspension will provide a convenient and straightforward dosing regimen which consists of twice daily dosing for 14 days without tapering.

Erick Co, President and CEO of Formosa Pharmaceuticals stated “With FDA approval now secured, we look forward to working with our US commercialisation 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.”

Formosa did not provide details on the pricing or the brand name for the eye drops.