Formosa Pharmaceuticals has announced the first shipment of its ophthalmic asset, clobetasol propionate ophthalmic suspension 0.05% (APP13007),to the US to facilitate commercialisation.
The drug, developed using Formosa's APNT nanotechnology platform, is the first US Food and Drug Administration (FDA)-approved ophthalmic solution featuring the super-potent corticosteroid clobetasol propionate.
Bora Pharmaceuticals Ophthalmic has manufactured the shipment of APP13007, which offers a twice-daily dosing regimen that is more convenient than the four doses per day required by other treatments.
Eyenovia, Formosa Pharma's US partner, initiated pre-launch activities and is expected to begin the commercialisation of APP13007 by late September 2024.
In 2023, Eyenovia acquired exclusive licensing and commercialisation rights for APP13007 in the US from Formosa Pharmaceuticals in an $86m deal.
In August 2024, Formosa obtained a drug export licence from Taiwan's Food and Drug Administration.
The licence has enabled the company to co-ordinate its first shipment to the US, a key step in its strategy for global commercialisation.
In anticipation of demand within the US market, Formosa is also collaborating with partners in other regions to prepare for regulatory submissions.
The goal is to make APP13007 available in international markets, expanding its reach beyond the US.
Formosa Pharmaceuticals focuses primarily on ophthalmology and oncology.
Its APNT technology enhances the dissolution, bioavailability and stability of active pharmaceutical ingredients, enabling the use of poorly soluble or highly potent drug agents.
Formosa Pharma president and CEO Dr Erick Co said, “This first shipment to Eyenovia for the much-anticipated commercial US launch is an exclamation point on our development of APP13007.
“We thank all our partners for making this journey with us and are eager to provide this formidable therapy to ocular surgery patients worldwide. We look forward to creating continued value for our stakeholders and shareholders.”
