Ocular Therapeutix provided an update on legal matters related to the company’s manufacture of its product candidate, Dextenza (dexamethasone insert) 0.4mg.
As the company previously disclosed in its periodic filings with the Securities and Exchange Commission, including its most recent quarterly report on Form 10-Q filed on November 7, 2017, the company and certain of its current and former executive officers and board members were named as defendants in a derivative lawsuit filed in the Superior Court of Suffolk County of the Commonwealth of Massachusetts, captioned Angel Madera v. Sawhney et al., Case No. 17-2273. As previously disclosed, the court dismissed the Madera lawsuit without prejudice because the plaintiff failed to serve the complaint in a timely manner under applicable court rules. On December 21, 2017, the company was served with a new derivative complaint that the same plaintiff filed in the same court, captioned Angel Madera v. Sawhney et al., Case. No. 1784cv04126. The new Madera complaint is premised on substantially similar allegations as the previous complaint, purports to assert derivative claims against certain current and former executive officers and board members for breach of fiduciary duty, unjust enrichment, and waste of corporate assets, and names the company as a nominal defendant. The new Madera complaint also asserts an unjust enrichment claim against two additional defendants, SV Life Sciences Fund IV, LP and SV Life Sciences Fund IV Strategic Partners LP. The company expects that this new Madera lawsuit will be consolidated with a second, previously disclosed derivative lawsuit that asserts similar claims and is pending before the same court, captioned Robert Corwin v. Sawhney et al., Case No. 17-3425 (BLS2). For more information on the claims alleged by these lawsuits, please see the company’s quarterly report on Form 10-Q filed on November 7, 2017. The company denies any allegations of wrongdoing and intends to vigorously defend against these lawsuits.
Additionally, as previously disclosed, the company and certain of its current and former executive officers were named as defendants in three securities class action lawsuits originally filed in federal court in New Jersey. The court granted the defendants’ motion to transfer these lawsuits to federal court in Massachusetts, where the cases are currently pending. The three lawsuits are captioned Thomas Gallagher v. Ocular Therapeutix, Inc, et al., Case No. 1:17-cv-12288, Dylan Caraker v. Ocular Therapeutix, Inc, et al., Case No. 1:17-cv-12146, and Shawna Kim v. Ocular Therapeutix, Inc, et al., Case No. 1:17-cv-12286. For more information on the claims alleged by these lawsuits, please see the Company’s Quarterly Report on Form 10-Q filed on November 7, 2017. The company denies any allegations of wrongdoing and intends to vigorously defend against these lawsuits.
Finally, the company has received a subpoena from the SEC, dated December 15, 2017, requesting documents and information concerning Dextenza (dexamethasone insert) 0.4mg, including related communications with the FDA, investors and others. The company intends to fully cooperate with the SEC regarding this non-public, fact-finding inquiry. 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 does not intend to comment further on this matter unless and until this matter is closed or further action is taken by the SEC which, in the company’s judgment, merits further comment or public disclosure.