FDA grants 510(k) clearance to Bausch + Lomb for Biotrue® Hydration Boost contact lens rehydrating drops

On Tuesday, Bausch + Lomb announced that the US Food and Drug Administration (FDA) has granted them 510(k) clearance for Biotrue® Hydration Boost contact lens rehydrating drops for soft and rigid gas permeable contact lenses. The preservative-free, multi-dose rehydrating drops provide up to eight hours of moisture in a laboratory study.

"We are proud to continue to build upon our successful Biotrue brand with the FDA clearance of Biotrue Hydration Boost for Contacts," said Joe Gordon, president, Global Consumer, Vision Care and Surgical, Bausch + Lomb, in a press release.

"Approximately, one-third of the 45 million contact lens wearers in the United States experience contact lens dryness,”1-3 Gordon continued. “We look forward to making this product available during the first half of 2023 to provide lens wearers with a new contact lens drop that delivers instant moisture and provides up to eight hours of moisture."

The Biotrue line continues to be inspired by the biology of the eye; in this case, the Hydration Boost contact lens drops combine ingredients informed by the Tear Film and Ocular Surface Society’s DEWS II report. Hyaluronan, a moisturizer that naturally exists in the eye, features prominently in the solution. Bausch + Lomb takes it a step further and matches the pH of healthy tears to encourage biologic synergy.

Companies are required to notify the FDA of intent to market a medical device at least 90 days in advance. This premarket notification allows the FDA to investigate whether the device is new or if it is equivalent to a device already on the market. Manufacturers are required to submit a premarket notification if the intention is to market a device for the first time or to reintroduce a device with significant changes to its design, material, chemical composition, energy source, manufacturing process, or intended use.

Biotrue Hydration Boost contact lens rehydrating drops are expected to hit the market in early 2023.

References

1. The 2021 study of the U.S. consumer contact lens market. Multi-Sponsor Surveys Inc. January 2022. Accessed December 14, 2022. https://www.multisponsor.com/wp-content/uploads/2022/03/US-Consumer-Contact-Lens-Market-MS2111.pdf

2. Contact lens care. American Optometric Association. Accessed December 14, 2022. https://www.aoa.org/healthy-eyes/vision-and-vision-correction/contact-lens-care?sso=y

3. Healthy contact lens wear and care: Fast facts. Centers for Disease Control and Prevention. Accessed December 14, 2022. https://www.cdc.gov/contactlenses/fast-facts.html