FDA Approves Clobetasol Propionate Ophthalmic Suspension for Post-Operative Ocular Care
The FDA has approved clobetasol propionate ophthalmic suspension 0.05% (APP13007) for managing post-operative inflammation and pain following ocular surgery. This approval marks a significant advancement in ocular care, offering a novel treatment option for patients undergoing various eye procedures.
Ocular surgery is commonly associated with inflammation and discomfort post-procedure, necessitating effective management strategies. The approval of clobetasol propionate ophthalmic suspension addresses this need by providing a potent corticosteroid formulation for alleviating post-operative symptoms.
Formosa Pharmaceuticals and AimMax Therapeutics collaborated to develop and obtain FDA approval for clobetasol propionate ophthalmic suspension. Eyenovia is poised to lead commercialization efforts in the US, facilitating access to this innovative treatment option for ophthalmologists and patients.
Clobetasol propionate ophthalmic suspension 0.05% is formulated using Formosa's APNT nanoparticle platform, delivering a potent corticosteroid directly to the affected area. Notably, this is the first FDA-approved ophthalmic clobetasol propionate product and the first new steroid introduced to the ophthalmic market in over 15 years.
The approval was based on robust evidence from two randomized, double-masked phase 3 clinical trials involving over 750 subjects undergoing cataract surgery. The trials demonstrated that the suspension provided rapid and sustained clearance of inflammation, surpassing placebo with statistical and clinical superiority (P <.001).
With approximately seven million ocular surgeries performed annually in the US, there exists a substantial market for post-surgical ocular care products. Clobetasol propionate ophthalmic suspension presents a promising opportunity, with its favorable dosing regimen and efficacy profile positioning it to capture a significant share of the $1.3 billion annual market.
The approval of clobetasol propionate ophthalmic suspension represents a significant advancement in ocular care, offering clinicians and patients an effective solution for managing post-operative inflammation and pain. This milestone underscores the importance of innovation in addressing unmet needs in ophthalmology and improving patient outcomes.
Reference:
Inc. FP. Formosa Pharmaceuticals and Aimmax Therapeutics announce the NDA submission to the US FDA for APP13007 for the treatment of post-operative inflammation and pain following ocular surgery. PR Newswire: press release distribution, targeting, monitoring and marketing. May 5, 2023. Accessed March 4, 2024. https://www.prnewswire.com/news-releases/formosa-pharmaceuticals-and-aimmax-therapeutics-announce-the-nda-submission-to-the-us-fda-for-app13007-for-the-treatment-of-post-operative-inflammation-and-pain-following-ocular-surgery-301815496.html.
