Bausch + Lomb requests extended wear for Ultra lenses
Bausch + Lomb has filed a Premarket Approval Application with the FDA for its Ultra contact lenses for up to 7 days of extended wear
The company announced in a press release that it fielded a 1-year, randomized, masked, controlled trial at 34 sites in the U.S. to assess the safety and efficacy of the Ultra samfilcon A soft contact lens for wear up to 7 days. These results have been submitted to the FDA.
“As patient care is our primary focus, it is important to provide eye care professionals another option to meet the unique lifestyle needs of their patients,” John Ferris, vice president and general manager at U.S. Vision Care at Bausch + Lomb, said in the release. “We believe Bausch + Lomb Ultra contact lenses deliver on these needs and are supported by clinical research to support the [Premarket Approval Application].”
Ultra contact lenses are also available for patients with astigmatism and presbyopia.