Formosa Pharmaceuticals' new post-operative ophthalmic anti-inflammatory and pain relief eye drop APP13007 has entered the final stage of licensing and is expected to be signed in the US within a month.

The first is APP13007, which completed its Phase III clinical trial at the end of last year. The US market is expected to sign the contract within a month, and the company will also apply for drug certification from the FDA by April, striving to market the drug by the end of this year. TSY-0110, an ADC developed in collaboration with Taikang Biotech, is expected to commence a Phase I clinical trial in the US in early 2024.

According to Formosa Pharmaceuticals, steroidal anti-inflammatory and pain relieving drugs are used after all ophthalmic surgeries performed in hospitals, with cataract surgery being the largest market, accounting for approximately US$600 million.

Formosa's APP13007 combines Clobetasol propionate, a steroid originally used to treat skin wounds, with the company's APNT nano-technology to develop a powerful and painless anti-inflammatory drug. While similar products in the market have a treatment duration of 3 to 4 drops per day and 3 to 4 weeks, Formosa's APP13007 can be administered as little as 2 drops per day and a treatment duration of 2 weeks.

According to a survey by Formosa Pharmaceuticals, there are approximately 7.5 to 8 million eye surgeries performed in the US each year, with an annual growth rate of over 2%.

In addition, the company has licensed APP13007 to Grand Pharma for sale in China, Hong Kong and Macau in 2021 for US$9 million. Grand Pharma announced in January this year that it had submitted a Phase III clinical application for APP13007 to the authority in China, and aims to start receiving cases in the second quarter, when it is expected to receive another milestone payment. According to Formosa Pharmaceuticals, although the scale of ophthalmic surgery in China is only one-fifth of that in the US, with the rapid growth of cataract and myopia populations in China, it is expected that there will be more room for growth than in the US in the future.

For TSY-0110, another of Formosa's assets, the original proprietary drug is Kadcyla developed by Roche, which has a market size of over US$2 billion. This year, meetings were held with the FDA and the European Union's EMA to discuss the same clinical trial design for Phase I. Therefore, the Phase I clinical trial originally scheduled to start in the second half of the year may not start until early next year.