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Panel advises FDA approval of 30-day lens

Issue: September 2001

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ROCKVILLE, Md. — If the Food and Drug Administration (FDA) follows the advice of its Ophthalmic Devices Panel, the United States could have a 30-day continuous-wear contact lens on the market as early as this fall.

On July 20, the panel unanimously recommended approval with conditions for CIBA Vision’s Focus Night & Day lenses for up to 30 nights of continuous wear. The FDA restricted the wearing duration of traditional extended wear lenses to 7 days more than a decade ago.

“I voted for approval with conditions because I felt the sponsor showed the safety and efficacy of the product. As a practitioner, I truly welcome this advance,” said panel member Janice M. Jurkus, OD, MBA.

The FDA will consider the panel’s recommendation as it completes its review of CIBA Vision’s Premarket Approval (PMA) application for the product. A decision regarding the application could be rendered as early as this fall.

Thirty nights of wear

If approved, the Focus Night & Day lens will be indicated “for the optical correction of refractive ametropia in phakic or aphakic persons with non-diseased eyes with up to approximately 1.50 D of astigmatism,” and may be prescribed for up to 30 nights of continuous wear. Made with a fluorosiloxane hydrogel material called lotrafilcon A, Focus Night & Day lenses have an oxygen transmissibility of 175 Dk/t.

In his presentation to the panel, CIBA Vision spokesman John McNally, OD, discussed the premarket studies conducted on the lens. The U.S. clinical study involved approximately 1,400 patients who were seen at 59 different investigational locations throughout the country. The trial was a non-inferiority study and was conducted over the course of 1 year.

According to Dr. McNally, the study found that Focus Night & Day was non-inferior to the control. The control used in the study was an Acuvue (Vistakon, Jacksonville, Fla.) lens worn for up to 1 week continuously and replaced on a weekly basis. The study did find a higher rate of giant papillary conjunctivitis (GPC) associated with contact lens wear in Focus Night & Day than in the control. No cases of microbial keratitis were found in either Focus Night & Day or the Acuvue lens.

Stuart Heap, president of CIBA Vision’s global lens business, also addressed the Ophthalmic Devices Panel. “The market needs an alternative to LASIK,” Mr. Heap said. “This is a lower-cost option that is flexible to the patient’s changing needs. We believe lotrafilcon will become the new standard for extended wear.”

Recommendation conditions

The conditions of the recommendation for approval are as follows:

• In the product’s indication statement, a claim of “less dry eye” in connection with the Focus Night & Day lens should be deleted.
• The labeling of the product should include study findings indicating a higher rate of GPC in the Focus Night & Day lens than in the Acuvue control group. These findings applied to those with a prior GPC history, as well as those without.
• The product labeling should indicate that the Focus Night & Day lens has not been tested on aphakic people.
• The labeling should include data specific to the earlier occurrence of corneal infiltrates in the Focus Night & Day lens than in the study’s control group. Labeling should also indicate that once an infiltrate had occurred with the Focus Night & Day lens, the chances of a second infiltrate incident increased sixfold.
• It should be stated on the product labeling that the risk of microbial keratitis in association with the lens has not been definitively established.
• Post-market studies were recommended by the panel.

Bausch & Lomb recently submitted its clinical data to the FDA for approval of PureVision (balafilcon A) soft contact lenses for 30-day continuous wear. PureVision has been available in the United States since 1999 for 7 days of continuous wear, and it has been available in Europe on a 30-day continuous wear basis. Focus Night & Day also has been available in Europe since 1999 on a 30-day continuous wear basis.

For Your Information:

• Janice M. Jurkus, OD, MBA, can be contacted at 3241 S. Michigan Ave., Chicago, IL 60616-3849; fax: (312) 949-7368.
• CIBA Vision can be contacted at 11460 Johns Creek Pkwy., Duluth, GA 30097; (770) 476-3937; Web site: www.cibavision.com.
• Bausch & Lomb Vision Care can be contacted at 1400 N. Goodman St., PO Box 450, Rochester, NY 14609-0450; (716) 338-6000; (800) 553-5340; fax: (716) 338-6896; Web site: www.bausch.com.