FDA OKs First Twice-Daily Topical Steroid for Postsurgery Eye Pain

Megan Brooks


August 24, 2018

The US Food and Drug Administration (FDA) has approved loteprednol etabonate ophthalmic suspension (Inveltys, Kala Pharmaceuticals) 1% for the treatment of pain and inflammation following eye surgery. 

It's the first topical ocular corticosteroid with twice-daily (BID) dosing rather than standard four-times-a-day dosing, the company said.

Loteprednol etabonate ophthalmic suspension is also the first product using the company's mucus-penetrating particle (MPP) technology, which uses  selectively sized nanoparticles to more efficiently deliver the drug to target tissues, the company explains in a news release.

"Approximately 8 million patients undergo ocular surgeries each year. The approval of Inveltys offers patients and their eye care professionals the first and only BID ocular corticosteroid therapy that has been shown in clinical trials to be clinically effective while maintaining a proven safety profile, which may improve compliance and prove less burdensome for patients," Kim Brazzell, PhD, chief medical officer of Kala Pharmaceuticals, said in the release.

"Today's approval of Inveltys is welcome news for the eye care community as it provides a clear advancement in the treatment for inflammation and pain following ocular surgery. Having access to a BID corticosteroid in a novel nanoparticle formulation with proven safety and efficacy will make a positive impact on the management of my post-operative patients," added Terry Kim, MD, professor of ophthalmology and chief, Cornea and External Disease Division, Duke University Eye Center, Durham, North Carolina.

Like other ophthalmic corticosteroids, Inveltys is contraindicated in most viral diseases of the cornea and conjunctiva, including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, as well as in mycobacterial infection of the eye and fungal diseases of ocular structures. Full prescribing information is available online.

The company expects to launch Inveltys in the beginning of 2019.

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