Class Action Lawsuit Claims OPTASE Eye Drops, Topicals Not FDA-Approved

New to ClassAction.org? Read our Newswire Disclaimer

A proposed class action lawsuit claims that several of Scope Health’s over-the-counter OPTASE eye medicines contain active pharmaceutical ingredients that are not approved by the Food and Drug Administration.

Want to stay in the loop on class action lawsuits that matter to you? Sign up for ClassAction.org’s free weekly newsletter.

According to the 13-page lawsuit, defendant Scope Health received on July 9, 2025 an FDA warning letter stating that four of its OPTASE topical ophthalmic products were unlawfully misbranded. The products mentioned specifically in the FDA’s warning letter include the OPTASE Hylo Night Ointment, OPTASE Moist Heat Mask, OPTASE Protect and OPTASE Dry Eye Intense Drops, the filing states.

The OPTASE products at issue, the complaint writes, were all marketed as therapeutic drugs but, per the FDA warning letter, “there are no FDA-approved applications in effect for any of the [identified] products.” Additionally, the OPTASE products are not considered “generally recognized as safe and effective” (GRASE), meaning they would require FDA approval to legally go to market, the suit shares.

The filing alleges, however, that the at-issue OPTASE products never received FDA approval, are not GRASE, and do not possess any FDA-approved applications, and that their introduction into commerce is a violation of federal law.

Regarding each relevant OPTASE product in particular, the lawsuit claims that:

• The Dry Eye Intense Drops contain the unapproved active ingredients trehalose and sodium hyaluronate and lack the required monograph warning “If solution changes color or becomes cloudy, do not use;”
• The Hylo Night Ointment, marketed as an ocular lubricant, contains vitamin A palmitate, which is not permitted under its monograph, and lacks adequate usage directions;
• The Protect product, marketed as an antimicrobial spray, contains polyminopropyl biguanide, which is not FDA-approved for ophthalmic use, and is not compliant with OTC drug regulations, and also lacks adequate usage instructions; and
• The Moist Heat Mask is sold as a drug-device product, often in conjunction with drug products, despite not having the proper approval or labeling, and is illegally misbranded.

The OPTASE class action lawsuit seeks to represent anyone who purchased the above-mentioned OPTASE products within the applicable statute of limitations period.

Check out ClassAction.org’s free legal resources to learn how to file a class action lawsuit.