The regulator has approved Eyenovia and Formosa’s ophthalmic clobetasol propionate solution to ease eye inflammation and pain after surgery, with a potential $1.3 billion market.
Pictured: FDA signage at its office in Maryland/iStock, hapabapa
Eyenovia and Taiwan-based development partner Formosa Pharmaceuticals on Monday announced that the FDA has approved their clobetasol propionate 0.05% eye drops for the treatment of post-operative inflammation and pain after eye surgery.
The product is the first FDA-approved ophthalmic clobetasol propionate drug to hit the market, and is the first steroid to enter the ophthalmic space in more than 15 years, according to Monday’s announcement.
Eyenovia CEO Michael Rowe in a statement said that the partners are currently working toward a “robust launch” of the product by mid-2024. “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.”
The FDA’s approval is supported by two pivotal randomized, double-masked and placebo-controlled Phase III trials enrolling nearly 750 patients. Together, the studies showed that the clobetasol propionate eye drops could rapidly and significantly clear ocular inflammation and relieve ocular pain within 14 days of treatment. The ophthalmic solution was also well-tolerated and had a safety profile similar to placebo.
First developed by Taiwanese biotech Formosa, the approved eye drop product is a topical ophthalmic steroid that contains the “super potent” corticosteroid clobetasol propionate, which has been documented to elicit rapid and sustained relief of both pain and inflammation.
The FDA previously approved clobetasol propionate in cream formulation for the treatment of pruritus in corticosteroid-responsive dermatosis in adults, for which it is being marketed as Clobex by Galderma.
Its current eyedrop formulation was developed using Formosa’ proprietary APNT nanoparticle formulation, and gives patients a more convenient route of administration. The ophthalmic clobetasol propionate product also has a straightforward dosing schedule of twice-daily for 14 days without tapering.
Eyenovia bought into the potential of Formosa’s clobetasol propionate eye drop formulation in August 2023, when it signed an $86 million deal for exclusive U.S. commercialization rights to the product. The sum covers Eyenovia’s upfront payment as well as development and sales milestones.
The ophthalmic clobetasol propionate product “will be a very synergistic addition to our commercial product portfolio,” which is anchored by MydCombi, its first-in-class microdose combination formulation of tropicamide and phenylephrine, approved to induce pupil dilation, Rowe said.
Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com.
