Ocular Therapeutix to file eye drug
This article was originally published in Scrip
Executive Summary
Massachusetts-based Ocular Therapeutix is set to file for US approval of its sustained-release dexamethasone product OTX-DP in the second quarter, following positive top-line data from the first of two Phase III trials in post-surgical ocular pain and inflammation. The company says that the ability to administer the entire course of therapy for post-operative inflammation and pain with a single dose would "remove the onus from patients to follow complex pharmaceutical dosing regimens while providing the desired tapered therapeutic effect". OTX-DP is placed in the canaliculus and designed to deliver dexamethasone to the ocular surface for about four weeks. The product resorbs and exits the nasolacrimal system without need for removal. The 247-patient study met both its efficacy endpoints, significantly improving pain and reducing the presence of inflammatory cells in the anterior chamber of the eye compared with placebo. Safety finding are still being analysed, and data from the second Phase III study are due by the end of the month.