Positive News has announced from the U.S. FDA! Formosa Pharmaceuticals, Inc. and AimMax Therapeutics, Inc. (USA) have jointly announced that their ophthalmic suspension of 0.05% loteprednol etabonate, known as APP13007 and utilized for the treatment of postoperative inflammation and pain in ophthalmology, has received marketing approval as of yesterday. Sales partner Eyenovia aims to initiate sales in the middle of this year, targeting the $1.3 billion market.
APP13007, developed utilizing Formosa Pharmaceuticals's proprietary APNTTM nano-microparticle formulation platform, marks the first approval by the U.S. FDA for the ocular use of loteprednol etabonate. Additionally, it stands as the first new ingredient approved for ophthalmic corticosteroid therapy in 15 years. This innovative drug provides patients with a convenient and straightforward dosing regimen: twice daily for 14 days, without the need for dose adjustment during treatment. Clinically and statistically, two Phase III clinical trials have confirmed that APP13007 clears inflammation and pain faster and more sustainably compared to placebo (p<0.001).
The United States currently conducts approximately 7 million ophthalmic surgeries annually, with the market for corticosteroids and corticosteroid combinations in ophthalmology reaching $1.3 billion. With regulatory approval secured, APP13007 can penetrate this market, offering significant commercial opportunities.
Dr. Erick Co, CEO of Formosa Pharmaceuticals, Inc., emphasized that this regulatory approval represents a significant milestone for the company, not only paving the way for its global expansion but also driving current and future research and development endeavors. With the confidence of obtaining U.S. regulatory approval, the company eagerly anticipates collaborating with commercial partner Eyenovia to introduce this product to more ophthalmologists and patients in the United States. Furthermore, efforts are underway to expand the market for 0.05% loteprednol etabonate suspension while advancing Formosa Pharmaceuticals's early-stage development projects to the next phase.
Dr. Laurene Wang, CEO of AimMax Therapeutics, extended congratulations to Formosa Pharmaceuticals, Inc. on its remarkable achievement and expressed enthusiasm for the opportunity to collaborate in bringing this novel and outstanding ophthalmic drug to market. This collaboration aims to aid millions of ophthalmic surgery patients annually in alleviating postoperative inflammation and pain and achieving rapid visual recovery.
Michael Rowe, CEO of Eyenovia, affirmed that the 0.05% loteprednol etabonate suspension undoubtedly enriches Eyenovia's commercial product portfolio. The company is honored to have earned the trust of Formosa Pharmaceuticals and is committed to promoting this significant asset in the United States. The team is diligently preparing to launch this product with its distinctive features and promising prospects in the middle of this year. With such advantages in dosing regimen, efficacy, and safety, Eyenovia firmly believes it has the potential to capture a significant share of the $1.3 billion market annually.
