Class Action Lawsuit Alleges OPTASE Eye Treatments Are Misbranded Due to Lack of FDA Approval

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Scope Health has been hit with a proposed class action lawsuit after receiving a 2025 warning letter from the Food and Drug Administration (FDA) indicating that its OPTASE-brand eye treatments are effectively unapproved new drugs and/or misbranded and thus unlawful to sell.

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The 15-page lawsuit claims that OPTASE eye products are misbranded under federal law due to the defendant’s marketing of the products as intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, including dry eye disease, meibomian gland dysfunction, and blepharitis. As a result of the marketing, the suit says, the FDA determined that the OPTASE eye treatments at issue are drugs within the meaning of the Federal Food, Drug, and Cosmetic Act and require an FDA-approved application to be lawfully sold.

In addition, the case states that the FDA found that the following OPTASE products were “not generally recognized as safe and effective” for their labeled uses, and that the agency was “not aware of any adequate and well-controlled clinical trials in the published literature” supporting their touted safety and effectiveness:

• -MGD Advanced Eye Drops;
• -Dry Eye Intense Drops (multi-use bottle and single dose);
• -Allegro Eye Drops;
• -HYLO Night Eye Ointment;
• -Tea Tree Oil Eyelid Wipes;
• -Tea Tree Oil Eyelid Gel; and
• -Protect Eyelid Cleansing Spray.

In fact, the lawsuit says that various OPTASE products contain active ingredients—like sacha inchi seed oil, trehalose and sodium hyaluronate—that are not FDA-approved for use in certain over-the-counter eye treatments. Moreover, the case states that because the OPTASE treatments cannot be sold under the FDCA, they similarly cannot be sold under California law, which requires certain products to be FDA-approved before hitting the market.

The suit was filed in the wake of Scope Health’s receipt of a warning letter from the FDA on July 9, 2025.

Consumers would not have bought the OPTASE eye treatments at issue, or would have paid less for them, had they known the products were unlawfully marketed and sold, the lawsuit says.

The OPTASE class action lawsuit looks to cover all individuals in California who, at any time from four years prior to the date of the filing of the complaint until the time a class is notified, purchased, for personal or household use, and not for resale or distribution, any of the OPTASE products listed on this page.

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