Formosa Receives FDA Approval for Clobetasol Formulation for Treatment of Postoperative Inflammation and Pain
Formosa Pharmaceuticals and AimMax Therapeutics announced that the FDA has approved clobetasol propionate ophthalmic suspension 0.05% (APP13007), for the treatment of postoperative inflammation and pain following ocular surgery.
Clobetasol propionate ophthalmic suspension 0.05% is derived from Formosa Pharma's proprietary APNT nanoparticle formulation platform. This 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 dosing regimen of twice daily for 14 days without tapering.
View EyewireTV's coverage of the approval here.
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 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," Erick Co, President and CEO of Formosa Pharmaceuticals, said in a company news release. "With FDA approval now secured, we look forward to working with our US commercialization partner, Eyenovia, to reach ophthalmologists and ocular surgery patients, while in parallel working to expand into additional territories and advance our earlier stage pipeline."
Eyenovia acquired the US commercial rights to clobetasol propionate ophthalmic suspension 0.05% from Taiwan-based Formosa Pharmaceuticals in August 2023. The total deal package, including upfront payment and development and sales milestones, has a value of $86 million dollars, with additional considerations throughout the term of the agreement.
"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," Michael Rowe, Chief Executive Officer of Eyenovia, said in the news release. "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."