Kala Pharmaceuticals has won FDA approval for a drug developed to treat pain and inflammation following eye surgery.
While the approval is new, the drug, loteprednol etabonate (Inveltys), is not. Kala’s drug is a new formulation of a Bausch Health (NYSE: BHC) topical steroid that is approved to treat pain and inflammation after eye surgeries. Both are eye drops. The difference is the version from Waltham, MA-based Kala uses nanoparticle technology intended to more efficiently deliver the therapeutic through the barriers of mucous in the eyes.
Compared to Baush’s drug, Kala says its product offers better efficacy and safety, and more convenience for patients. It’s approved for twice daily dosing, versus the four times a day dosing of the drug from Bausch (formerly Valeant Pharmaceuticals). Kala did not disclose drug pricing, but said it has started discussions with insurance companies. The company plans to launch the drug in early 2019.
Despite the FDA decision handing Kala (NASDAQ: KALA) its first drug approval, the company’s stock price dipped to $12.55, down 6.9 percent from Wednesday’s closing price.
Approval of the Kala drug offers validation of the company’s technology, which has roots at MIT. The company says its nanoparticles allow a drug to be evenly distributed on mucosal surfaces, increasing the delivery of the therapy to its target. Kala plans use this technology to develop new therapies for other eye conditions, too. The next drug in Kala’s pipeline is KPI-121, an experimental treatment for dry eye disease. The company says it plans to apply for FDA approval of that drug in the second half of this year, based on one Phase 2 study and two Phase 3 studies that tested the drug in approximately 2,000 patients.
But Kala is also enrolling a third Phase 3 trial, based on recommendations from the regulator following a meeting in June. That study will test four-times-a-day dosing of KPI-121 against a placebo for 14 days. The main goal of the study is evaluating the severity of eye pain at day 15. Preliminary results from that study, which will enroll an estimated 900 patients, are expected in the fourth quarter of 2019.
Here’s more on Kala’s nanoparticle technology and its application in eye drugs.