In a significant development, the United States Food and Drug Administration (FDA) has granted approval for clobetasol propionate ophthalmic suspension 0.05% (APP13007) to address post-operative inflammation and pain following ocular surgery. The announcement, made on March 4, 2024, marked the collaboration between Formosa Pharmaceuticals and AimMax Therapeutics, with commercialization in the US led by Eyenovia.
Erick Co, President, and CEO of Formosa Pharmaceuticals, expressed enthusiasm about the FDA approval, stating, “With FDA approval now secured, we look forward to working with our US 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.”
Clobetasol propionate ophthalmic suspension 0.05% is a product of the company’s APNT nanoparticle formulation platform, utilizing a potent corticosteroid. It holds the distinction of being the first FDA-approved ophthalmic clobetasol propionate product and the first new steroid introduced to the ophthalmic market in over 15 years.
Laurene Wang, PhD, Founder, and CEO of AimMax Therapeutics, praised the achievement, stating, “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.”
The New Drug Application (NDA) for clobetasol propionate ophthalmic suspension 0.05% was submitted jointly by Formosa Pharmaceuticals, Inc. and AimMax Therapeutics, Inc. in May 2023. The steroid offers patients a straightforward dosing regimen of twice daily for 14 days without tapering.
The approval was based on two randomized, double-masked phase 3 clinical trials conducted at more than 60 sites in the United States, comparing APP13007 to its matching placebo among approximately 750 subjects following cataract surgery. In both trials, clobetasol propionate ophthalmic suspension 0.05% demonstrated rapid and sustained clearance of inflammation that was statistically and clinically superior versus the placebo (P <.001).
With a current market size of $1.3 billion for topical ophthalmic steroids and steroid combinations in the United States, and approximately seven million ocular surgeries performed annually, the introduction of this differentiated product is anticipated to capture a significant share of the market. Michael Rowe, CEO of Eyenovia, affirmed, “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.”
