Investor Alert: Kaplan Fox Announces Investigation Of Ocular Therapeutix, Inc.

NEW YORK, July 19, 2017 /PRNewswire/ -- Kaplan Fox & Kilsheimer LLP (www.kaplanfox.com) is investigating claims on behalf of investors of Ocular Therapeutix, Inc. ("Ocular Therapeutix" or the "Company") (NASDAQ: OCUL). 

Class action litigation has been filed in the United States District Court for the District of New Jersey against Ocular Therapeutix and Company executives on behalf of investors who purchased or otherwise acquired Ocular Therapeutix securities between May 5, 2017 and July 6, 2017, inclusive (the "Class"), alleging violations of the Securities Exchange Act of 1934.

According to the complaint, on May 5, 2017 Ocular Therapeutix disclosed that it received a Form 483 from the U.S. Food and Drug Administration ("FDA") documenting FDA concerns discovered during inspection of Ocular Therapeutix's manufacturing operations.  During an earnings conference call held the same day, Ocular Therapeutix's Executive Vice President of Regulatory, Quality, and Compliance, Eric Ankerud, represented that the Company expected to resolve the issue in a timely manner by responding to the FDA within 15 days.  On July 6, 2017, STAT published an article asserting that Ocular Therapeutix's drug DEXTENZA could be rejected by the FDA because of product contamination, including aluminum, found by an FDA inspector during a visit to the Company's manufacturing facility. Following this news, Ocular Therapeutix's stock price fell $3.06 per share, or more than 30%, over two trading days to close at $7.12 per share on July 7, 2017.

Then, after the Class Period, on July 10, 2017, the Company issued a press release disclosing its submission of a "major amendment" to its New Drug Application ("NDA") that "modified a piece of manufacturing equipment referenced in the NDA resubmission" and that the Company "will be submitting data on a new commercial batch to demonstrate that this modification, along with other improvements, has addressed outstanding issues regarding particulate matter." 

On July 11, 2017 after market, the Company issued a press release disclosing receipt of a Complete Response Letter ("CRL") from the FDA stating that the FDA has determined that it cannot approve the NDA in its present form.  The CRL also reportedly states that the amendment was not reviewed prior to the FDA's issuance of the CRL.  Following this news, the Company's share price declined by $0.93 per share, or 12.2%, to close at $6.67 per share on July 12, 2017.

The complaint alleges, among other things, that throughout the Class Period defendants made false and misleading statements and/or failed to disclose that (1) Ocular Therapeutix was experiencing significant manufacturing issues with respect to DEXTENZA, including that more than 50% of lots manufactured by Ocular Therapeutix contained bad product, and (2) such manufacturing issues could imperil DEXTENZA's approval by the FDA.

If you are a member of the proposed Class, you may move the court no later than September 5, 2017 to serve as a lead plaintiff for the purported class.  You need not seek to become a lead plaintiff in order to share in any possible recovery.  If you would like to discuss the complaint or our investigation, please contact us by emailing [email protected] or by calling 800-290-1952.

This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and ethical rules.

Kaplan Fox & Kilsheimer LLP, with offices in New York, San Francisco, Los Angeles, Chicago and New Jersey, has many years of experience in prosecuting investor class actions. For more information about Kaplan Fox & Kilsheimer LLP, you may visit our website at www.kaplanfox.com.  If you have any questions about this Notice, the action, your rights, or your interests, please contact:

Donald R. Hall
KAPLAN FOX & KILSHEIMER LLP
850 Third Avenue, 14th Floor
New York, New York 10022
(800) 290-1952
(212) 687-1980
Fax: (212) 687-7714
E-mail: [email protected]

Laurence D. King
KAPLAN FOX & KILSHEIMER LLP
350 Sansome Street, Suite 400
San Francisco, California  94104
(415) 772-4700
Fax:  (415) 772-4707
E-mail: [email protected]

SOURCE Kaplan Fox & Kilsheimer LLP

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