Lawsuit: Ocular Therapeautix Blinded Investors to Issues with New Drug’s Approval

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Ocular Therapeautix, Inc. and four top executives are facing a securities lawsuit filed in August that claims the parties misled investors regarding the pending approval of DEXTENZA, a new medicine designed to treat post-surgical eye pain. According to the complaint, the company admitted in March 2016 that the FDA had conducted a pre-approval inspection of DEXTENZA and noted several issues with the manufacturing process. Despite this news, the case says, the defendants continuously assured investors that the problems were being addressed and the drug was on track for approval.

On July 6, 2017, however, several news sources reported that the FDA had completed a second inspection and found that the company had not resolved the previous manufacturing problems, the complaint alleges. One article reportedly noted of Ocular that “[its] whole approach to manufacturing and patient safety is highly questionable.”

According to the complaint, Ocular’s stock prices fell 36 percent upon release of this news and declined an additional 12 percent after the FDA denied approval of DEXTENZA a few days later. The suit argues that the defendants knew of the problems facing the drug’s approval but published misleading statements to deceive potential investors, thereby injuring them when the truth was finally revealed.