The US Food and Drug Administration (FDA) has approved a new corticosteroid, clobetasol propionate ophthalmic suspension 0.05% (APP13007), for the treatment of postoperative inflammation and pain following ocular surgery, report Formosa Pharmaceuticals (Taiwan) and AimMax Therapeutics (United States).

Clobetasol propionate ophthalmic suspension 0.05% is the first FDA-approved ophthalmic clobetasol propionate product, as well as the first new steroid drop on the ophthalmic market in more than 15 years. It offers a convenient and straightforward dosing regimen (twice daily for 14 days without tapering).

Two phase 3 clinical trials (NCT04739709 and NCT04810962) met their primary endpoints by producing rapid and sustained clearance of ocular inflammation and pain relief that was statistically and clinically superior to its matching placebo. The drops are derived from Formosa Pharma's proprietary APNT nanoparticle formulation platform.

The eyedrop enters a $1.3 billion market for topical ophthalmic steroids and steroid combinations, driven by an estimated 7 million ocular surgeries performed annually in the United States. Eyenovia, a commercial-stage ophthalmic pharmaceutical technology company, acquired the US commercial rights to clobetasol propionate ophthalmic suspension 0.05% from Formosa Pharmaceuticals in August 2023. “We are working towards a robust launch mid-year starting with an educational campaign focused on cataract surgeons,” Michael Rowe, Eyenovia’s chief executive officer, said in a press release.