Formosa Pharmaceuticals, based in Taiwan, and AimMax Therapeutics jointly announced on Monday that the U.S. Food and Drug Administration (FDA) has granted approval for clobetasol propionate ophthalmic suspension 0.05% (APP13007) to address post-operative inflammation and pain subsequent to ocular surgery.
Derived from Formosa Pharma’s exclusive APNT nanoparticle formulation platform, this ophthalmic solution utilizes a potent corticosteroid, marking it as the first FDA-approved clobetasol propionate product for ocular use. Additionally, it stands as the first new steroid to enter the ophthalmic market in over 15 years, providing patients with a convenient and straightforward dosing regimen of twice daily for 14 days without tapering.
Two Phase 3 clinical trials underscored the efficacy of the product, demonstrating rapid and sustained clearance of inflammation and statistically and clinically superior pain relief compared to its placebo counterpart.
With this approval, the eyedrop enters the $1.3 billion market for topical ophthalmic steroids and steroid combinations, driven by an estimated seven million ocular surgeries conducted annually in the United States.
Formosa Pharmaceuticals’ U.S. commercialization partner for this breakthrough is Eyenovia Inc (NASDAQ:EYEN). The collaboration, initiated in August 2023, granted Eyenovia exclusive U.S. rights to commercialize APP13007 for inflammation and pain following ocular surgery. The partnership involved an $86 million agreement, including upfront payment and milestones, with additional considerations throughout the agreement terms.
Although clinical studies focused on patients post-cataract surgery, the approved indication extends beyond this, covering post-operative inflammation and pain following any ocular surgery. This broader indication suggests a substantial market potential for the newly approved product.
Eyenovia is currently exploring the potential development of APP13007 in Optejet for the dry eye market, estimated to be approximately $3.6 billion in the United States. Management has indicated that they are awaiting approval before proceeding with the dry eye program, with the aim of leveraging the approved filing for strategic advantages.
Following the FDA approval, financial analysts at William Blair have adjusted the risk-adjusted fair value from $5 to $7 per share, providing an Outperform rating for the company.
