Posted from: Monday, September 17, 2018 - 12:26 PM - Present

Inveltys Approved as New Ophthalmic Corticosteroid

August 22, 2018 – The U.S. FDA has approved Inveltys™ (loteprednol etabonate ophthalmic suspension) 1%, manufactured by Kala Pharmaceuticals, to treat post-operative inflammation and pain after eye surgery. It is the first twice-daily ocular corticosteroid approved under this indication.

According to the manufacturer, approximately 8 million individuals undergo eye surgery each year. Other corticosteroids approved to provide post-operative pain relief and reduce inflammation following such procedures must be taken four times per day, and close adherence to prescribed corticosteroid use can play a key role in proper recovery. Kala Pharmaceuticals believes the twice-daily dosing regimen of Inveltys has the potential to improve patient adherence.

Recommended dosing is one to two drops in the affected eye two times per day. Treatment should begin the day after surgery, and typically continues through the first two weeks of the post-operative period. Intraocular pressure should be checked regularly if treatment with Inveltys extends beyond 10 days, as prolonged use of corticosteroids in the eye can lead to glaucoma or damaged optic nerves.

Kala plans to launch Inveltys in early 2019. Pricing information has not yet been announced.

 

Last Updated Friday, October 19, 2018 - 01:33 AM.