Taiwan-based Formosa Pharmaceuticals and AimMax Therapeutics announcedthat the U.S. Food and Drug Administration (FDA) has approved clobetasol propionate ophthalmic suspension 0.05% (APP13007), for the treatment of 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. This innovative 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 clinical trials demonstrated rapid and sustained clearance of inflammation and pain relief that was statistically and clinically superior to its matching placebo (p<0.001). This novel eyedrop enters a $1.3 billion dollar market for topical ophthalmic steroids and steroid combinations, driven by an estimated seven million ocular surgeries performed annually in the United States.
“This approval marks Formosa Pharma’s entry into the global marketplace and provides a critical foundation and momentum for continued development, as well as advancement of new endeavors. With immense gratitude, we thank our development colleagues at AimMax Therapeutics for their wisdom and tenacity in guiding the program through to success. Equally, we recognize the tireless efforts of our employees and unwavering support from colleagues in the realization of this corporate milestone,” said Erick Co, president and CEO of Formosa Pharmaceuticals. With FDA approval now secured, we look forward to working with our U.S. commercialization partner, Eyenovia, Inc., to reach ophthalmologists and ocular surgery patients, while in parallel working to expand into additional territories and advance our earlier stage pipeline.”
“We congratulate Formosa Pharma for the achievements and are extremely pleased with the collaborative opportunity to bring this novel and impressive formulation to the market to benefit millions of patients for the ease of use and rapid recovery and regain of visual acuity after ocular surgery” said AimMax Therapeutics’ founder and CEO, Laurene Wang, PhD.
“We believe clobetasol propionate ophthalmic suspension 0.05% will be a very synergistic addition to our commercial product portfolio, and we are honored that Formosa has entrusted Eyenovia with the marketing of this important asset in the United States,” stated Michael Rowe, CEO of Eyenovia. “We are already working diligently toward a robust launch of this differentiated and desirable product mid-year, and we believe that, given its more favorable posology and profile compared to other post-surgical steroid options, it has the potential to capture a significant share of an estimated $1.3 billion annual market opportunity.”