This article is more than 5 years old. Information may no longer be current.
The pursuit of extended wear approval
Click Here to Manage Email Alerts
DULUTH, Ga. and ROCHESTER, N.Y. — Two companies are seeking U.S. Food and Drug Administration (FDA) approval for 30-day continuous wear of their soft contact lenses. The PureVision lens (Bausch & Lomb, Rochester, N.Y.) and the Focus Night & Day lens (CIBA Vision, Duluth, Ga.) both have approval for 30-day continuous wear in markets outside of the United States, and both are aggressively pursuing that designation in this country.
The PureVision lens is undergoing FDA clinical trials, said William T. Reindel, OD, director of global professional marketing for Bausch & Lomb, but he said it was difficult to determine when 30-day approval might be obtained. “Our intent is to get approval, but it’s difficult to predict how long the FDA review process will take,” he said. “We are aggressively pursuing it.”
PureVision, which was launched in the United States last year, has FDA approval for 7-day continuous wear, but the pursuit of 30-day approval started long before that, said Dr. Reindel. “It was part of our long-term plan, because we are very confident in the breakthrough nature of this product,” he said.
The Focus Night & Day lens, as well, has long been the target for 30-day wear by CIBA Vision, said Gregory J. White, category director for lens marketing. “We have actually worked with the FDA from the beginning of this project, which was about 7 years ago,” he said. “We are working with the FDA and the Contact Lens Institution to establish new extended wear guidelines. We have 30-night approval outside the United States in most major markets including Europe, so it is, obviously, something in which we are very interested.”
Mr. White, as well, said that it would be difficult to give specifics about where the approval process stands for the Focus Night & Day lens for 30-day wear, although the company remains in close contact with the FDA. The Focus Night & Day is not yet available in the United States.
Either way, said Dr. Reindel, the introduction of 30-day extended wear lenses is an important stride in the contact lens industry. “Silicone hydrogel contact lenses (CIBA Night & Day or Bausch & Lomb’s PureVision) represent a scientific breakthrough for contact lenses,” he said. “They are an advancement in terms of addressing the challenges of making a lens, composed of water and silicone to produce a material with high oxygen permeability. As a new advancement in technology, practitioners should be taking advantage of them for any patient in overnight wear.”
For Your Information:
- William T. Reindel, OD, is the director of global professional marketing at Bausch & Lomb. He may be reached at Bausch & Lomb, 1400 North Goodman St., Rochester, NY 14603-0450; (716) 338-8129; fax: (716) 338-0897.
- Gregory J. White is the category director of lens marketing at CIBA Vision. He may be reached at 11460 Johns Creek Parkway, Duluth, GA 30097; (678) 415-3646; fax: (678) 415-3592.
- PureVision lenses are available from Bausch & Lomb. The company is located at 1400 North Goodman St., Rochester, NY 14603-0450; (716) 338-6000; fax: (716) 338-6896; Web site: www.bausch.com.