INDIA— Eyenovia and Taiwan-based development partner Formosa Pharmaceuticals have announced that Eyenovia’s eye drops have been approved by the United States Food and Drug Administration to relieve inflammation and pain in patients who have had eye surgery.

Eyenovia acquired the drug’s commercial rights in the United States from Formosa in August for $86 million.

The medicine is the first ophthalmic clobetasol propionate drug approved by the FDA, as well as the first steroid to enter the ocular sector in over 15 years.

The FDA’s approval followed evidence from two late-stage trials conducted by Formosa on patients who had undergone cataract surgery.

In both studies, the drops, known as APP13007, were given twice a day for two weeks and helped minimize post-surgical ocular inflammation and pain.

Clobetasol propionate in cream formulation was previously licensed by the FDA for the treatment of pruritus in adults with corticosteroid-responsive dermatosis, and Galderma markets it as Clobex.

Its current eyedrop formulation was created using Formosa’s unique APNT nanoparticle formulation, which provides patients with a more simple method of administration.

The ophthalmic clobetasol propionate product similarly has a straightforward dose schedule: twice daily for 14 days without tapering.

The medication, which contains strong topical steroid clobetasol propionate, is commonly used to treat skin disorders such as eczema and psoriasis. It has been demonstrated to elicit quick and lasting alleviation of both pain and inflammation. 

Until now, the steroid has not been utilized to treat eye disorders.

While making the announcement, Eyenovia CEO Michael Rowe claimed that Eyenovia was preparing to introduce the device mid-year and hopes to capture a major piece of an estimated $1.3 billion yearly market opportunity.

He went on to say that this ophthalmic clobetasol propionate product will be a very synergistic addition to their commercial pharmaceutical portfolio that is anchored by MydCombi, their first-in-class microdose combination formulation of tropicamide and phenylephrine, approved to produce pupil dilation.

According to Reuters, Formosa has not yet released the price or brand name of the eye drops.

The U.S. health authorities have also approved Bausch + Lomb’s Lotemax, which is used three times daily, to manage inflammation and pain following eye surgery.

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