The FDA approved Kala Pharmaceuticals' loteprednol etabonate ophthalmic suspension 1 percent for postsurgery eye pain and inflammation.
Here are four insights:
1. Inveltys is the first approved topical ocular corticosteroid with twice-daily dosing. Other ocular steroids are only approved for four-times-a-day dosing.
2. Inveltys relies on the company's mucus-penetrating particle technology to deliver loteprednol etabonate to target tissues.
3. Inveltys is contraindicated in most cornea and conjunctiva viral diseases, and in mycobacterial eye infections and ocular fungal diseases.
4. Kala Pharmaceuticals plans to launch the drug in early 2019.
"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," said Kala Pharmaceuticals CMO Kim Brazzell, PhD.