This article is more than 5 years old. Information may no longer be current.
FDA approves PureVision lenses for 30 days of continuous wear
Click Here to Manage Email Alerts
ROCHESTER, N.Y. — The U.S. Food and Drug Administration (FDA) has approved Bausch & Lomb’s PureVision contact lenses for up to 30 days of continuous wear. The approval comes less than a month after Bausch & Lomb filed a lawsuit against CIBA Vision Corp. for infringement of Bausch & Lomb’s patent rights to extended-wear soft contact lenses.
“Bausch & Lomb is proud to provide the 30-day option with our patented PureVision lenses,” said Mark M. Sieczkarek, Bausch & Lomb senior vice president and president of the Americas Region. “Nearly 13 million American contact lens wearers may be eligible to join the hundreds of thousands of patients in more than 40 countries who already wear PureVision lenses for up to 30 days.”
In 1999, the FDA approved Bausch & Lomb’s PureVision lenses for up to 7 days of continuous wear. Clinical studies to measure safety and efficacy of 30-day wear in the United States began in 1999 and involved 820 patients and 35 clinical investigators.
Patent infringement suit
In October 2001, the FDA approved CIBA Vision’s Focus Night & Day contact lenses for up to 30 days of wear. On Nov. 6, Bausch & Lomb filed its patent infringement suit against CIBA Vision in the U.S. District Court for the Western District of New York, Rochester.
In the suit, Bausch & Lomb asked the court to issue a preliminary injunction to prevent CIBA Vision from marketing its Focus Night & Day lenses in the United States. B&L spokeswoman Margaret Graham told Primary Care Optometry News that, ultimately, a permanent injunction will be sought.
“Bausch & Lomb has a patent for extended-wear silicone hydrogel soft contact lenses,” Ms. Graham said. “CIBA’s product, Focus Night & Day, infringes on that patent, so Bausch & Lomb is suing to protect and enforce our patent rights.”
Increased oxygen transmissibility
Both Focus Night & Day and PureVision lenses are made from silicone hydrogel materials, which provide increased oxygen transmission to the eye. The use of these materials makes the lenses more conducive to extended wear.
Bausch & Lomb’s PureVision lenses are available in +6.00 D to –6.00 D in 0.25-D steps, and –6.50 D to –9.00 D in 0.50-D steps. CIBA Vision’s Focus Night and Day lenses will be available in a power range of +0.25 D to +6.00 D in 0.25-D steps, –0.25 D to –8.00 D in 0.25-D steps and –8.50 D to –10.00 D in 0.50-D steps.
According to Bausch & Lomb’s lawsuit, the technology used in Focus Night & Day lenses is a breach of Bausch & Lomb’s patent. “They are infringing on our patent, which essentially covers the making of a contact lens that uses at least three specific ingredients,” Ms. Graham said. “They are a polysiloxane containing urethane prepolymer, tris (trimethylsiloxy) silylpropyl methacrylate and N-vinyl-2-pyrrolidinone or N, N-dimethylacrylamide.”
Similar litigation
CIBA Vision spokeswoman Kristie Madara said CIBA Vision has had similar litigation pending against Bausch & Lomb since 1999, regarding four U.S. patents on Focus Night & Day lenses.
Ms. Madara maintained that Bausch & Lomb’s lawsuit is an attempt to stall these court proceedings. “We believe Bausch & Lomb’s lawsuit is just another litigation tactic to delay the legal proceedings that have been going forward,” she told Primary Care Optometry News. “Basically, the company has tried a number of things to delay the case.”
In addition to the injunction, Bausch & Lomb is seeking “unspecified financial damages” from CIBA Vision, Ms. Graham said. “Ultimately, we would like to get a permanent injunction prohibiting CIBA from selling this product, which infringes on our patent,” she said.
Ms. Madara maintained that CIBA Vision stands behind the validity of its numerous patents. “We’ve launched our product, and we’re on the market,” she said. “We’re moving forward with marketing our product. We are confident in the validity of our patents.”
For Your Information:
- Mark M. Sieczkarek is Bausch & Lomb’s senior vice president, as well as president of the Americas region. He can be reached at Bausch & Lomb Incorporated, One Bausch & Lomb Place, Rochester, NY 14604-2701; (800) 289-9030; fax: (800) 356-8056.
- Margaret Graham is a spokesperson for Bausch & Lomb Inc. She can be reached at One Bausch & Lomb Place, Rochester, NY 14604-2701; (716) 338-5469; fax: (716) 338-0317.
- Kristie Madara is a spokesperson for CIBA Vision Corp. She can be reached at 11460 Johns Creek Pkwy., Duluth, GA 30097-1556; (678) 415-3646; fax: (678) 415-3592.