The medication is used to treat inflammation and pain after eye surgery. Credit: Marina Vitale on Unsplash.

Taiwan-based Formosa Pharmaceuticals has signed an exclusive licensing agreement with Apotex to commercialise clobetasol propionate ophthalmic suspension 0.05% (APP13007), for ocular surgery relief and recovery.

Apotex has gained commercialisation rights for the ophthalmic suspension in Canada.

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The medication is used to treat inflammation and pain after eye surgery.

The US Food and Drug Administration (FDA) approved APP13007 in March 2024.

The latest agreement includes upfront and milestone payments based on regulatory and sales achievements in Canada.

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Formosa Pharmaceuticals president and CEO Erick Co stated: “Formosa Pharma is honoured to partner with Apotex, with its storied history and reputation for success. “Their commitment to branded ophthalmology products gives us full confidence that APP13007 will flourish in the Canadian market. We look forward to working with the Apotex team in providing this differentiated therapy to Canadian physicians and patients.”

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The active ingredient of APP13007 is clobetasol propionate, a corticosteroid created using Formosa Pharma’s APNT nanoparticle formulation platform.

The formulation offers a convenient twice-daily dosing regimen for 14 days, providing rapid and sustained relief of inflammation and pain, as demonstrated by its superior performance in Phase III trials compared to a placebo.

Apotex president and CEO Allan Oberman stated: “We are pleased to provide Canadian patients with APP13007, a new treatment option for post-operative inflammation and pain following ocular surgery.

“Expanding our portfolio of innovative medicines, including our ophthalmic portfolio, along with our commercial infrastructure, enables us to support more patients along their journey to health.”

The latest development comes after Formosa entered into an exclusive licensing agreement with Tabuk Pharmaceuticals, granting the latter exclusive rights to commercialise the clobetasol propionate ophthalmic suspension 0.05% (APP13007) in key Middle East and North African regions.