Bausch + Lomb gets 510(k) clearance from FDA

VAUGHAN, Ontario – Bausch + Lomb Corp. announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for Biotrue Hydration Boost Contact Lens Rehydrating drops, a preservative-free multi-dose rehydrating drop for use with soft and rigid gas permeable contact lenses.

“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. “Approximately, one-third of the 45 million contact lens wearers in the United States experience contact lens dryness. “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.”

Inspired by the biology of the eye, Biotrue Hydration Boost Contact Lens drops contain a combination of ingredients informed by the Tear Film and Ocular Surface Society’s DEWS II report including hyaluronan, a moisturizer found naturally in the eye, and other naturally inspired ingredients. Biotrue Hydration Boost for Contacts also matches the pH of healthy tears for comfort.

“Many of my patients experience dry, uncomfortable contact lenses throughout the day,” said Mile Brujic, O.D., premier vision group, Bowling Green, Ohio. “The availability of Biotrue Hydration Boost for Contacts will help my patients quickly reduce their contact lens-related dryness. I look forward to recommending this product to patients as soon as it is available next year.”