FDA approves Inveltys for treatment of inflammation and pain after ophthalmology surgery

, Kala Pharma recently completed the announcement that the U.SFood andDrug(
FDA()) has approved Inveltys (chloretteno leachate, 1%) for the treatment of inflammation and pain after ophthalmic surgeryInveltys is the first eye corticosteroid drug approved for this indication twice a day (BID)KalaPharmaceutical(The Company's(which plans tothe new nanoparticle formproduct (to the U.Smarket) in early 2019Currently, all other eye steroid drugs on the market are approved only four times a day, and this more frequent dosing requirement may cause problems for doctors and patientsCorticosteroids are the basic therapy for ophthalmology after surgery, the main purpose of which is to control the inflammation and pain of the eye caused by surgical traumaThe use of eye steroids after surgery is intended to rapidly reduce inflammation and promote eye healingTherefore, ensuring close adherence to steroid protocols is a key factor in the overall success of doctors in postoperative care for patients and the final surgeryInveltys is a new nanoparticle formulation of BID corticosteroids that have been shown to be of good safety and efficacy and will undoubtedly have a positive impact on the management of ophthalmology patientsIn addition to Inveltys, Kala Pharmaceuticals is also developing another eye product, KPI-121 (0.25%), for the treatment of dry eye diseaseCurrently, the product has launched a third STRIDE study to assess the symptoms and signs used to temporarily relieve dry eye diseaseKala Pharma also plans to submit KPI-121'sNew Drug(NDA) in the second half of this year, which will include data from three clinical studies, including one Phase II study and two Phase III studies, for approximately 2,000 patients in the group