FDA Approves Clobetasol Propionate Eye Drop for Post-Ocular Surgery Pain

Credit: US Food and Drug Administration

The United States Food and Drug Administration (FDA) has approved clobetasol propionate ophthalmic suspension 0.05% (APP13007) for treating post-operative inflammation and pain following ocular surgery.¹

Announced on March 4, 2024, a collaborative team of Formosa Pharmaceuticals and AimMax Therapeutics was awarded FDA approval for the ophthalmic suspension. Eyenovia is expected to lead commercialization in the US.

“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,” said Erick Co, president, and chief executive officer of Formosa Pharmaceuticals, in a statement.¹

Clobetasol propionate ophthalmic suspension 0.05% is derived from the company’s APNT nanoparticle formulation platform and utilizes a potent corticosteroid. The formulation is the first FDA-approved ophthalmic clobetasol propionate product and the first new steroid in over 15 years on the ophthalmic market.¹

“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,” Laurene Wang, PhD, founder and chief executive officer of AimMax Therapeutics, said in a statement.¹

The New Drug Application (NDA) for clobetasol propionate ophthalmic suspension 0.05% was submitted by Formosa Pharmaceuticals, Inc. and AimMax Therapeutics, Inc. in May 2023.² The steroid grants patients a straightforward dosing regimen of twice daily for 14 days without tapering.

Approval was granted based on two randomized, double-masked phase 3 clinical trials, conducted at more than 60 sites in the United States. Both trials compared APP13007 to its matching placebo among approximately 750 subjects following cataract surgery. In each trial, clobetasol propionate ophthalmic suspension 0.05% displayed rapid and sustained clearance of inflammation that was statistically and clinically superior versus placebo (P <.001).

Currently, there is a $1.3 billion market for topical ophthalmic steroids and steroid combinations in the United States. Approximately seven million ocular surgeries are performed annually in the United States.

“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,” Michael Rowe, chief executive officer of Eyenovia, added in a statement.¹

References

1. _{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.}
2. _{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. Formosa Pharmaceuticals, Inc. May 5, 2023. Accessed March 4, 2024. https://www.formosapharma.com/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/.}