FDA Approves Clobetasol Propionate Ophthalmic Suspension for Post-Operative Ocular Care

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.