Ocular Therapeutix (NSDQ:OCUL) is facing a revived class-action lawsuit lodged by investors after its share price took a hit after it revealed problems with its Dextenza device.
The lawsuit, filed in the U.S. District Court for Massachusetts in November 2017, alleged that the Bedford, Mass.-based company misled shareholders about problems found by FDA inspections in 2017 that sent its stock into a tailspin.
The FDA issued a Form 483 in May 2017 detailing process control problems at the plant where Dextenza is made, a year after the federal safety watchdog denied approval in another Form 483 due to “deficiencies in manufacturing process and controls” after a pre-approval inspection. News of the Form 483 spooked investors and prompted the lawsuit, covering shareholders who bought the stock between March 10, 2016 and July 11, 2017.
The suit was dismissed April 30, after Judge George O’Toole Jr. found that the plaintiffs failed to prove any actionable misstatements or omissions by the company.
The plaintiffs filed a notice of appeal May 31 to the U.S. Court of Appeals for the First Circuit.
“The company denies any allegations of wrongdoing and intends to continue to vigorously defend against this litigation,” Ocular Therapeutix said in a regulatory filing this week.
