EyePoint Pharmaceuticals Agrees to $4.6 Million False Claims Act Settlement

Key Takeaways

• EyePoint Pharmaceuticals agreed to pay $4.6 million to resolve False Claims Act allegations involving the marketing of DEXYCU (dexamethasone intraocular suspension) to ambulatory surgery centers; the settlement resolves allegations only, with no determination of liability.
• The US Department of Justice (DOJ) alleged the company used reimbursement support and free drug samples to encourage product purchases, resulting in claims submitted to federal health care programs.
• As part of the settlement, EyePoint will enter a 5-year Corporate Integrity Agreement, while the whistleblower who brought the case will receive a share of the federal recovery.

EyePoint Pharmaceuticals has agreed to pay over $4 million to resolve allegations that it violated the federal False Claims Act by providing unlawful kickbacks to ambulatory surgery centers (ASCs) to encourage the purchase and use of DEXYCU, an injectable corticosteroid indicated for the treatment of ocular inflammation following cataract surgery. The settlement resolves allegations only, and there has been no determination of liability.

Government Details Alleged Marketing Practices

According to the DOJ, the alleged conduct occurred between January 1, 2019, and March 1, 2023, following DEXYCU's commercial launch. Federal prosecutors alleged that EyePoint implemented an Assurance Program that reimbursed or compensated ASCs when insurers denied coverage for DEXYCU or reimbursed the drug below the centers' acquisition cost. The government also alleged that the company provided excessive quantities of free drug samples to participating ASCs.

Prosecutors contend these practices constituted unlawful remuneration intended to induce providers to purchase and dispense DEXYCU, resulting in false claims submitted to federal health care programs.

Federal Officials Emphasize Enforcement Priorities

The DOJ stated that such financial incentives can influence prescribing and dispensing decisions while increasing costs to federal health care programs. Assistant Attorney General Brett A. Shumate of the Justice Department's Civil Division said the department will continue pursuing pharmaceutical companies that use unlawful kickbacks to promote products.

US Attorney Leah B. Foley for the District of Massachusetts added that enforcement actions seek to eliminate financial incentives that could affect clinical decision-making and protect federal programs from fraud, waste, and abuse.

Settlement Includes Corporate Integrity Agreement

As part of the resolution, EyePoint agreed to enter into a 5-year Corporate Integrity Agreement with the Health and Human Services Office of Inspector General. Under separate agreements, the company will also make additional payments totaling $21 518.68 to certain participating states.

Whistleblower Case and Settlement Terms

The settlement resolves claims brought under the qui tam, or whistleblower, provisions of the False Claims Act. The lawsuit was filed by AFCE LLC in the US District Court for the District of Massachusetts. Under the settlement, the whistleblower will receive $791 768.74 from the federal recovery.

The investigation was conducted by the DOJ's Civil Division Commercial Litigation Branch, the US Attorney's Office for the District of Massachusetts, the HHS Office of Inspector General, and the Federal Bureau of Investigation. The government noted that the settlement resolves allegations only and that there has been no determination of liability.

Bottom Line

This settlement underscores the federal government's continued enforcement of the False Claims Act and Anti-Kickback Statute in the pharmaceutical industry, particularly regarding manufacturer financial assistance and marketing programs. Although EyePoint denied liability, the resolution—including a $4.6 million payment and a 5-year Corporate Integrity Agreement—highlights the compliance risks associated with programs that could be perceived as influencing product selection or utilization by health care providers.

Reference

EyePoint Pharmaceuticals to pay $4.6 million to resolve False Claims Act Allegations. US Department of Justice. Press release. Published July 17, 2026. Accessed July 21, 2026. https://www.justice.gov/opa/pr/telemedicine-company-owner-and-author-health-care-compliance-books-sentenced-136m-medicare