Bausch + Lomb settles with DOJ for Ista

May 28, 2013

B+L subsidiary Ista pleads guilty to conspiracy charges in anti-kickback case and agrees to pay $34M in civil and criminal fines.

Rochester, NY-Bausch + Lomb’s subsidiary Ista Pharmaceuticals, Inc. has reached agreement with the U.S. government to resolve civil and criminal allegations against Ista. The settlement involves conduct by Ista that occurred between January 2006 and March 2011, prior to B+L’s acquisition.

Ista has pled guilty to charges of:

• Conspiracy to introduce a misbranded drug in interstate commerce with intent to defraud and mislead

• Conspiracy to violate the anti-kickback statute

As part of the settlement, Ista has agreed to pay approximately $34M in civil and criminal fines, will be prohibited from participating in federal healthcare programs such as Medicare and Medicaid. Ista products Bepreve (bepotastine besilate), Bromday (bromfenac), Istalol (timolol), Prolensa (bromfenac), and Vitrase (hyaluronidase) have been transferred to B+L and are not subject to any exclusion resulting from this settlement and continue to be eligible for reimbursement under those programs.

Bausch + Lomb was aware of the government investigation prior to its acquisition, and has fully cooperated with the government to resolve this matter. The government has acknowledged that it has no knowledge that Bausch + Lomb, any current director or officer of Bausch + Lomb, or any current director or officer of ISTA was party to any conduct related to this case.

Since acquiring Ista in 2012, Bausch + Lomb has integrated its portfolio of products and related operations, and will wind down the Ista entity by the end of the year.