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FDA approves Inveltys for treatment of inflammation, pain after ocular surgery
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The FDA has approved Inveltys, a twice-daily ocular corticosteroid, for the treatment of postoperative inflammation and pain after ocular surgery, according to a Kala Pharmaceuticals press release.
Inveltys (loteprednol etabonate ophthalmic suspension 1%) is the first twice-daily ocular steroid for the treatment of inflammation and pain after ocular surgery to be approved by the FDA.
“Prior to the launch of Inveltys, all available post-surgical corticosteroids were approved with four-times-a-day dosing. This more frequent dosing requirement can lead to issues for both doctors and patients. Corticosteroids are the foundation of therapy for post-ocular surgery care, with the key goal of controlling inflammation and pain which is caused by surgical trauma to the eye. The use of ocular steroids post-surgery is to achieve a rapid reduction of inflammation and to promote healing of the eye. Therefore, ensuring close adherence to the steroid regimen is a critical factor for physicians in the post-surgery care of the patient and eventual overall success of the procedure. Inveltys is the first ocular corticosteroid approved for BID dosing,” Kim Brazzell, PhD, chief medical officer of Kala, told Healio.com/OSN.
Inveltys successfully completed two phase 3 clinical trials that showed statistical significance for its primary efficacy endpoints of complete resolution of inflammation and pain at postoperative day 8 through day 15 compared with placebo.
Mark Iwicki, chairman, president and CEO of Kala, said in the press release that the company expects to launch Inveltys in the beginning of 2019.
“We believe that Inveltys will address some key unmet needs for ocular surgery patients by delivering strong efficacy with a favorable safety profile and with a less frequent dosing regimen of BID compared to QID for all existing corticosteroids,” Brazzell told Healio.com/OSN. – by Robert Linnehan
Perspective
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John A. Hovanesian, MD, FACS
Approval of Inveltys is the next triumph in ocular drug delivery. Using mucus penetrating particle technology to enhance penetration of loteprednol, the drug demonstrated efficacy in controlling postoperative pain and inflammation with twice daily dosing. It is now much easier for our surgical patients to get in all of their postop drops, with an active compound that is trusted by surgeons for its safety.
The growing list of these novel anti-inflammatories is exciting. In February, the FDA approved EyePoint’s Dexycu, an extended release dexamethasone preparation that is delivered into the anterior chamber. Soon, we also hope to see the approval of Dextenza from Ocular Therapeutix, a dexamethasone depot made of a slow-eluting hydrogel that is placed into the tear punctum. These products will all greatly simplify the lives of both surgeons and patients undergoing cataract surgery.
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