Kala Pharmaceuticals announced that the FDA has approved Inveltys (loteprednol etabonate ophthalmic suspension 1%) for the treatment of postoperative inflammation and pain following ocular surgery. Inveltys is the first twice-daily (BID) ocular corticosteroid approved for this indication.
“The FDA approval of Inveltys is a tremendous milestone for Kala,” Kim Brazzell, PhD, Chief Medical Officer of Kala Pharmaceuticals, said in a company 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. We believe Inveltys will be an important addition to eye care professionals’ treatment armamentarium.”
All other ocular steroids are only approved for 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.
“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,” Terry Kim, MD, Professor of Ophthalmology and Chief, Cornea and External Disease Division, Duke University Eye Center, said in the news release.
“On behalf of the Kala team, I want to thank the many patients and clinicians who participated in our clinical trials. With this approval, our ongoing commercialization preparations now advance to the next phase where we plan to hire a specialty sales force that will focus on eye care professionals in the United States. We expect to launch Inveltys in the beginning of 2019,” said Mark Iwicki, Chairman, President and Chief Executive Officer of Kala Pharmaceuticals.
Kala also continues to advance KPI-121 0.25% for dry eye disease. Kala has initiated a third phase 3 clinical trial, STRIDE 3 (STRIDE – Short Term Relief In Dry Eye), evaluating KPI-121 0.25% for the temporary relief of the signs and symptoms of dry eye disease. Kala believes that the changes made to the design of STRIDE 3 will improve its probability of success. The company expects to report topline results for STRIDE 3 in the fourth quarter of 2019. Kala also plans to submit a new drug application (NDA) for KPI-121 0.25% during the second half of 2018. The NDA will include data from three clinical trials studying approximately 2,000 patients, including one phase 2 trial and two phase 3 efficacy and safety trials (STRIDE 1 and STRIDE 2).