Formosa Pharmaceuticals announced that the company has entered into a licensing agreement with CRISTALIA PRODUTOS QUIMICOS FARMACEUTICOS LTDA ("Cristalia"), for exclusive Brazilian rights to the commercialization of APP13007 (clobetasol propionate ophthalmic nanosuspension, 0.05%) for the treatment of inflammation and pain following ocular surgery. APP13007 is currently under review by the U.S. Food and Drug Administration (FDA) and has been assigned a Prescription Drug User Fee Act (PDUFA) date of March 4, 2024. The licensing deal includes upfront, development milestones, and sales royalties, with additional considerations throughout the term of the agreement.

APP13007's active ingredient is the superpotent corticosteroid, clobet asol propionate, and is derived from Formosa Pharma's proprietary APNT?? nanoparticle formulation platform. The novel formulation enables a convenient and straightforward dosing regimen (twice daily for 14 days) while providing rapid and sustained relief of inflammation and pain, which in Phase 3 trials proved statistically and clinically superior to its matching placebo (p<0.001).

If approved, APP13007 will join in a potential and growing market in Brazil for topical ophthalmic steroids.