Pharma Focus Asia

FDA Approves Clobetasol Propionate Ophthalmic Suspension for Post-Operative Pain after Ocular Surgery

Tuesday, March 05, 2024

Today, Formosa Pharmaceuticals (6838.TWO), headquartered in Taiwan, in partnership with AimMax Therapeutics based in the United States, announced a significant milestone: the U.S. Food and Drug Administration (FDA) has granted approval for their clobetasol propionate ophthalmic suspension 0.05% (APP13007). This approval paves the way for its use in treating post-operative inflammation and pain following ocular surgery.

Derived from Formosa Pharma’s proprietary APNT™ nanoparticle formulation platform, this innovative product marks the first FDA-approved ophthalmic clobetasol propionate medication and the first new steroid introduced in over 15 years in the ophthalmic market. Its unique formulation offers patients a convenient dosing regimen (twice daily for 14 days without tapering), promising swift and sustained relief from inflammation and pain. Results from two Phase 3 clinical trials demonstrated its superiority over placebo, both statistically and clinically (p<0.001).

With approximately seven million ocular surgeries performed annually in the United States, this novel eyedrop enters a lucrative market estimated at $1.3 billion for topical ophthalmic steroids and steroid combinations.

Erick Co, President and CEO of Formosa Pharmaceuticals, expressed gratitude towards AimMax Therapeutics for their instrumental role in guiding the program to success, alongside acknowledging the dedication of their employees and support from collaborators. Co emphasized that FDA approval serves as a springboard for global expansion, with plans to collaborate with U.S. commercialization partner Eyenovia, Inc., to reach ophthalmologists and patients. Simultaneously, they aim to explore opportunities in additional territories and advance their pipeline projects.

Laurene Wang, Ph.D., Founder and CEO of AimMax Therapeutics, congratulated Formosa Pharma on this achievement, highlighting the collaborative effort to bring this innovative formulation to market and its potential to benefit millions of patients undergoing ocular surgery.

Michael Rowe, CEO of Eyenovia, expressed enthusiasm about the addition of clobetasol propionate ophthalmic suspension 0.05% to their commercial product portfolio, emphasizing its potential to capture a significant share of the market due to its favorable posology and profile compared to other post-surgical steroid options. Eyenovia is gearing up for a robust mid-year launch of this product, aiming to capitalize on the estimated $1.3 billion annual market opportunity.



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