Formosa Pharmaceuticals has contracted Bora Pharmaceuticals to produce its new ophthalmic drug APP13007, which will begin shipping to partner EYENOVIA in the third quarter, marking its official entry into the U.S. market. Given that the market for postoperative ophthalmic medications in the U.S. is worth $1.3 billion annually, the company's future business plans and the development status of its subsequent new drugs are highly anticipated topics for the pre-listing investor conference on the 16th.
Formosa Pharmaceuticals, the first biotech company to transition to a public listing this year, has developed APP13007, a 0.05% clobetasol propionate ophthalmic suspension. This drug received FDA approval for market release in March this year. Designed for the treatment of inflammation and pain following ophthalmic surgery, APP13007 utilizes Formosa Pharmaceuticals's proprietary APNT nanoparticle formulation platform to deliver a highly potent corticosteroid, clobetasol propionate. It is the first clobetasol propionate medication approved by the FDA for ophthalmic use and the first new corticosteroid component approved for ophthalmic use in 15 years. The drug offers a convenient and direct dosing regimen for patients: twice daily for 14 days without the need for dosage adjustment throughout the treatment.
Two Phase III clinical trials in the U.S., involving nearly 750 participants, confirmed that the 0.05% clobetasol propionate ophthalmic suspension effectively and consistently reduces inflammation and pain faster than a placebo (p<0.001). Market data indicates that approximately 7 million ophthalmic surgeries are performed annually in the U.S., with the postoperative ophthalmic steroid and steroid-combination drug market valued at $1.3 billion.
APP13007 was developed using Formosa Pharmaceuticals's exclusive APNT nanoparticle formulation technology, combined with Formosa Laboratories' expertise in active pharmaceutical ingredient handling and analysis, and Bora Pharmaceuticals' subsidiary, Synpac-Kingdom Pharmaceutical's, sterile production and mass production experience in ophthalmic formulations. Since 2019, the companies have pooled their resources and expertise to progressively scale up production, making APP13007 the first locally developed, manufactured, and exported new drug from Taiwan to the U.S. market.
In addition to the new ophthalmic drug APP13007, Formosa Pharmaceuticals is also collaborating with Formosa Laboratories and EirGenix on the development of an ADC breast cancer treatment drug, EG12043, which is expected to enter human clinical trials in the second half of this year.
Resource (mandarin): 台新藥法說會 新藥備受關注
