In a recent announcement from Formosa Pharmaceuticals and AimMax Therapeutics, the FDA has granted approval for clobetasol propionate ophthalmic suspension 0.05% to address inflammation and pain after ocular surgery. This marks a significant milestone as the formulation becomes the first ophthalmic clobetasol propionate product to receive FDA approval and the first new steroid in the ophthalmic market in over 15 years.
Erick Co, President, and CEO of Formosa expressed optimism, stating, “We believe ophthalmologists will be enthusiastic about having a new tool (first new steroid in the indication in more than 15 years) to address the aftereffects of ocular surgery.” The dosing regimen, identified through a commissioned key opinion leader survey, involves twice-daily application for 14 days, offering a compelling value proposition that differentiates it from standard care.
Clobetasol propionate ophthalmic suspension 0.05% (APP13007) demonstrated its efficacy in two phase 3 clinical trials, showcasing “rapid and sustained clearance of inflammation and pain relief.” Statistical and clinical superiority over placebo (P < .001) was evident, instilling confidence among ophthalmologists.
The acquisition of U.S. commercial rights to APP13007 by Eyenovia in August 2023 paves the way for its imminent launch in the U.S. market, expected as soon as this summer. The company also envisions the product’s potential as a treatment for dry eye disease, aligning with longer-term plans for expanded applications.
Co elaborated on their goals, stating, “The immediate goal is working closely with our established commercialization partners toward launch while expanding our reach into new territories. Furthermore, we are actively exploring additional ophthalmic and non-ophthalmic indications with APP13007, leveraging clobetasol propionate’s unique anti-inflammatory potency and profile.” This FDA approval signifies a breakthrough in ocular care, offering a new and potent solution for post-operative inflammation and pain.
