Bausch + Lomb settles with DOJ for Ista

Article

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.

Newsletter

Want more insights like this? Subscribe to Optometry Times and get clinical pearls and practice tips delivered straight to your inbox.

Recent Videos
Carolyn Majcher, OD, FAAO, detailed a talk she gave alongside Mary Beth Yackey, OD, at Optometry's Meeting 2025.
Shelby Brogdon, OD, details opportunities for practices to answer the patient's concerns from the chair before they hit the internet for their contact lens needs.
Christi Closson, OD, FAAO, shares her excitement for the new Acuvue Oasys MAX 1-Day multifocal for astigmatism
Karen R. Hoffman, OD, shares how customizable scleral lenses can transform vision for patients with complex corneas, achieving 20/20 outcomes and enhanced comfort.
Janna Pham, OD, shares key takeaways from a corneal tomography session she presented alongside Travis Pfeifer, OD, and Matthew McGee, OD.
Jacob Lang, OD, FAAO, details early symptom relief demonstrated in as early as day 1 during AOA's Optometry's Meeting 2025.
When Langis Michaud, OD, MSc, FAAO, FSLS, FBCLA, FEAOO, began fitting scleral lenses 20 years ago, there was limited knowledge about conjunctival characteristics, scleral shape, and lens behavior.
Ioussifova details what sets Johnson & Johnson's new lens apart from the rest, which was launched at the American Optometric Association's Optometry's Meeting 2025.
Alongside Rachel Steele, OD, Rafieetary outlines what to look for in blurred disc margins and the importance of acting fast and sending patients to the ED when needed.
Langis Michaud, OD, MSc, FAAO, FSLS, FBCLA, FEAOO, emphasized that every staff member should play a role in myopia management during his presentation at Optometry's Meeting 2025.
© 2025 MJH Life Sciences

All rights reserved.