Ocular Therapeutix received a subpoena from the SEC on Dec. 15, 2017, for documents and information pertaining to its Dextenza 0.4mg and related communication with the FDA, investors and other parties. The company received a second subpoena on Aug. 21, 2018, for documents and information about its participation in two investor conferences in June 2017.
The company also recently settled a patent dispute with Mati Therapeutics over its Dextenza ocular insert. In the settlement, the Centers for Medicare and Medicaid Services won reimbursement and both Ocular Therapeutix and Mati Therapeutics dismissed all claims and counterclaims against each other in the U.S. District Court for the District of Delaware.
The Dextenza device is designed to deliver drugs for up to 30 days following treatment in a physician’s office. Ocular Therapeutix is positioning its product as a way to eliminate the current standard of care for post-surgical pain – topical steroid eye drops.