Ocular Therapeutix (NSDQ:OCUL) revealed last week that it received a subpoena from the Securities and Exchange Commission dated Dec. 15, requesting information about the company’s post-surgical pain relief implant, Dextenza, which was rejected by the FDA earlier this year.
The Bedford, Mass.-based company did not specify what the SEC was asking for, but noted that the request covers communications between Ocular Therapeutix and the FDA, as well as investors.
“The company intends to fully cooperate with the SEC regarding this non-public, fact-finding inquiry,” Ocular said in a release. “The SEC has informed the company that this inquiry should not be construed as an indication that any violations of law have occurred or that the SEC has any negative opinion of any person, entity or security.”
The company’s Dextenza device is designed to deliver a sustained dose of dexamethasone over four weeks following eye surgery. But Ocular has faced several obstacles getting its product to the market in the U.S. – it has twice received the FDA’s dreaded complete response letter.
In July last year, the FDA denied approval for Ocular’s hydrogel plug after it discovered ‘deficiencies in manufacturing process and controls’ in a pre-new drug application approval inspection.
Also this year, the company announced that its founder, Amarpreet Sawhney, would step down as president & CEO, assuming the role of executive chairman.
