Federal securities regulators are asking questions about an Ocular Therapeutix eye pain product that was rejected by the FDA in July.
Ocular (NASDAQ: [[ticker:OCUL]]) received a subpoena from the Securities and Exchange Commission dated Dec. 15, the Bedford, MA, company said Friday after the markets closed. The subpoena seeks documents and information regarding the company’s lead product candidate, Dextenza. In a news release, Ocular characterized the SEC communication as a “non-public, fact-finding inquiry.”
The company gave no details about what the SEC was asking, though it did say that the regulator’s inquiry covers communications with the FDA, investors, and unspecified other parties. Ocular added that the SEC told the company that the inquiry does not indicate that any laws were broken. Investors were cool to the news nonetheless, and Ocular’s stock price slipped more than 7 percent to $4.25 per share in after-hours trading.
Dextenza is a combination drug and medical device meant to treat pain following eye surgery. Inserted in the eye, Dextenza slowly releases dexamethasone, a steroid commonly used to treat eye redness and swelling. Over time, the Ocular product dissolves. In July, the FDA rejected Ocular’s application for approval, citing problems found during an inspection of a site used to manufacture Dextenza, according to the company’s summary of its correspondence with the FDA.
Shortly after the FDA’s rejection of Dextenza, Ocular began a corporate restructuring that brought in a new CEO and cut 19 percent of the company’s workforce. The company also found itself the target of several shareholder lawsuits claiming that the company made false or misleading statements regarding the manufacturing problems found by the FDA. In its most recent quarterly report, Ocular denies any wrongdoing.
Ocular said in a prepared statement that it is cooperating with the SEC’s inquiry but doesn’t intend to comment further on the matter.
[Photo of SEC headquarters by Flickr user Scott S via a Creative Commons license.]
