Taiwan-based clinical-stage biotech company Formosa Pharmaceuticals has entered into an exclusive licensing agreement with Arrotex Pharmaceuticals Pty Ltd. for the commercialization of clobetasol propionate ophthalmic suspension 0.05% (APP13007) in Australia and New Zealand.
The agreement grants Arrotex exclusive rights to commercialize APP13007, a novel topical ophthalmic corticosteroid developed using Formosa’s proprietary Advanced Particle Nanoparticle Technology (APNT) formulation platform. The deal includes upfront payments, regulatory and sales-based milestone payments, as well as royalties over the term of the agreement.
APP13007, approved by the US Food and Drug Administration in 2024, represents a significant advancement in ophthalmic drug formulation and delivery. The therapy utilizes the superpotent corticosteroid clobetasol propionate and is engineered through APNT technology to enhance dissolution, bioavailability, and therapeutic performance. The optimized nanoparticle formulation enables a simplified twice-daily dosing regimen over 14 days, delivering rapid and sustained relief from inflammation and pain following ocular surgery.
According to a U.S. survey of 100 ophthalmic surgeons, approximately 80% of patients were pain-free within four days post-surgery, with adverse events reported in less than 2% of cases—key factors supporting its clinical adoption.
The licensed territory represents a significant market opportunity, with an estimated 250,000 cataract surgeries performed annually across Australia and New Zealand and steady year-on-year growth anticipated.
Erick Co, President and CEO of Formosa Pharmaceuticals, stated that the partnership reflects strong confidence in APP13007’s differentiated formulation and therapeutic profile. He noted that Arrotex’s national distribution strength will support broad access for post-surgical ophthalmic patients.
Matt Zeller, CEO of Arrotex Pharmaceuticals, added that the agreement strengthens the company’s expanding specialist care portfolio and reinforces its commitment to delivering innovative and accessible medicines across Australia and New Zealand.
Formosa Pharmaceuticals continues to advance its pipeline in ophthalmology and oncology through its APNT-enabled drug development platform, which enhances active pharmaceutical ingredient (API) solubility and bioavailability across topical, oral, and inhaled dosage forms.
Arrotex Pharmaceuticals, Australia’s largest and most diversified pharmaceutical company, supplies approximately 50% of the country’s prescription medicine volume and maintains a leading presence in ophthalmology, supported by a nationwide sales and distribution infrastructure.
