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FDA approves Menicon Z RGP contact lenses for continuous wear

Issue: September 2002

BySuzanne Bryla

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NAGOYA, Japan – The Food and Drug Administration has approved Menicon Z Rigid Gas Permeable (RGP) contact lenses, developed by Japanese contact lens maker, Menicon Co. Ltd., for 30-day continuous wear in the United States.

The Menicon Z lens is the first RGP contact lens to receive FDA approval for 30-day continuous wear. The approval includes spherical, aspherical, custom toric and multifocal designs.

Two other companies have received FDA approval for the sale of soft, 30-day continuous wear lenses in the United States. PureVision by Bausch & Lomb received approval in November 2001, and CIBA Vision’s Focus Night and Day received approval in October 2001. All three contact lenses approved for 30-day continuous wear use hyper-Dk oxygen-transmitting materials, allowing for increased oxygen transmission to the eye compared to conventional lenses, making them conducive to extended wear.

In the United States, 85% of the people who wear contact lenses wear soft lenses because they are just more comfortable, said H. Dwight Cavanagh, MD, PhD, vice chairman of ophthalmology and associate dean for clinical services at UT Southwestern Medical Center, Dallas. “But the nice thing is that patients now have another choice. Some patients have astigmatism and cannot use a soft lens. They need an RGP, and now they have an option for extended wear. The important thing is that this new class of materials — the hyper-Dk oxygen-transmitting materials — is going to replace everything out there for both daily and extended wear,” he told Primary Care Optometry News.

Advantages of RGP

Menicon Z lenses offer high oxygen transmissibility without sacrificing mechanical strength. Also, in bacterial-binding studies, the RGP lenses caused less microbial keratitis in either mode of wear, daily or extended.

“In my opinion, the rigid lens is always going to be safer for the risk of microbial keratitis than the soft lens,” Dr. Cavanagh said. Dr. Cavanagh, who has conducted research for 15 years for the Menicon Company, is also an investigator for the FDA and was part of the clinical trials for the Menicon Z.

He said that in bacterial-binding studies, the Menicon Z lens had no increase in Pseudomonas bacterial binding to corneal epithelial cells in humans in 30-day wear. However, the two 30-day soft lenses, which had significantly less bacterial binding than conventional soft lenses, still had more bacterial binding than the Menicon Z.

Marketing the Menicon Z

Menicon Z lenses were first introduced to the U.S. market in 1996, approved for daily wear. They were approved for 7-day extended wear in July 2000. In February 2001, the lenses were CE approved for continuous wear up to 30 days in Europe.

Con-Cise Contact Lens, based in San Leandro, Calif., which has been manufacturing and marketing the Menicon Z lens in the United States since it was introduced for daily wear, will continue to make and distribute the lens with the 30-day approval. “It’s the very same lens except that Menicon did the appropriate testing to get the 30-day approval,” said Carl Moore , president of Con-Cise Contact Lens.

“We have been making this lens and this material for some time now, and it’s a nice extra benefit for the practitioners who have been using the lens,” Mr. Moore said.

The extended-wear modality will be officially launched at the International Vision Expo West in Las Vegas, Sept. 12-14.

For Your Information:

• H. Dwight Cavanagh, MD, PhD, is vice chairman of ophthalmology and associate dean for clinical services at The University of Texas Southwestern Medical Center, Department of Ophthalmology, 5323 Harry Hines Blvd., Dallas, TX 75390-9057; (214) 648-8074; fax: (214) 648-9061. Dr. Cavanagh has no direct financial interest in the products mentioned in this article. He is a paid consultant for Menicon Co. Ltd.
• Carl Moore, president of Con-Cise Contact Lens, can be reached at 14520 Doolittle Dr., San Leandro, CA 94577; (800) 772-3911; fax: (800) 772-3922. Mr. Moore has a direct financial interest in Menicon.
• Menicon America Inc., of Menicon Co.’s U.S. office, can be reached at (650) 373-1425; fax: (650) 378-1426; www.menicon.com.

• The Menicon Z lens is available from Con-Cise Contact Lens, 14520 Doolittle Drive, San Leandro, CA 94577; (800) 772-3911; fax: (800) 772-3922; Web site: www.con-cise.com.