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Taiwan-based Formosa Pharmaceuticals has entered into an exclusive licensing agreement with Arrotex Pharmaceuticals, for exclusive rights to the commercialisation of clobetasol propionate ophthalmic suspension, 0.05% (APP13007), an innovative topical eyedrop for the treatment of inflammation and pain following ocular surgery in Australia and New Zealand.
Australia-based Arrotex currently fulfills 50% of the country's total volume and is a leader in ophthalmology. The licensing arrangement includes upfront, regulatory milestones, sales milestones, and royalty considerations throughout the terms of the agreement.
APP13007's active ingredient is the superpotent corticosteroid, clobetasol propionate, and is derived from Formosa Pharma's proprietary APNT® nanoparticle formulation platform.
The novel formulation, approved by the US FDA in 2024, enables a convenient and straightforward dosing regimen (twice daily for 14 days) while providing rapid and sustained relief of inflammation and pain.
In a US survey of 100 ophthalmic surgeons, rapid resolution of pain (~80% pain-free four days post-surgery) and low incidence of adverse events (<2%) were highlighted as key drivers to prescribing APP13007. The licensing territory is estimated to have approximately 250,000 cataract surgeries annually with anticipated YOY growth.
