Benzinga - by Vandana Singh, Benzinga Editor.
Taiwan-based Formosa Pharmaceuticals and AimMax Therapeutics announced Monday that the FDA approved clobetasol propionate ophthalmic suspension 0.05% (APP13007) for post-operative inflammation and pain following ocular surgery.
Utilizing a super potent corticosteroid, clobetasol propionate ophthalmic suspension 0.05% is derived from Formosa Pharma’s proprietary APNT nanoparticle formulation platform.
The formulation represents the first FDA-approved ophthalmic clobetasol propionate product and the first new steroid in over 15 years on the ophthalmic market, offering patients a convenient and straightforward dosing regimen (twice daily for 14 days without tapering).
Two Phase 3 trials demonstrated rapid and sustained clearance of inflammation and pain relief that was statistically and clinically superior to its matching placebo.
This eyedrop enters a $1.3 billion market for topical ophthalmic steroids and steroid combinations, driven by an estimated seven million ocular surgeries performed annually in the United States.
Eyenovia Inc (NASDAQ:EYEN) is Formosa Pharmaceuticals’ U.S. commercialization partner.
In August 2023, Formosa Pharmaceuticals partnered with Eyenovia, where by Eyenovia obtained exclusive U.S. rights for commercializing APP13007 for inflammation and pain following ocular surgery, $86 million, including upfront payment and milestones, with additional considerations throughout the agreement terms.
William Blair says that although clinical studies on APP13007 were conducted in patients after cataract surgery, its approved indication extends beyond post-cataract surgery.
The approval covers post-operative inflammation and pain following ocular surgery, indicating a broad market potential.
Eyenovia is considering the development of APP13007 in Optejet for the dry eye market, estimated to be around $3.6 billion in the United States. Management said it awaits approval before proceeding with the dry eye program, aiming to leverage the approved filing for strategic advantages.
With the approval, William Blair increased the risk-adjusted fair value from $5 to $7 per share, with an Outperform rating.
Price Action: EYEN shares are down 0.30% at $23.04 on the last check Tuesday.
Photo by Amanda Dalbjörn on Unsplash
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