Eyeglass exemption added to final Stark II regulation
Visx, B&L end patent feud
Lasik Vision to receive $7 million financing, new CEO
Introducing Novartis Ophthalmics
News article about disclosure of physician errors termed misleading
Sunrise announces distribution deal, expense cuts
Briefs

Eyeglass exemption added to final Stark II regulation

Postcataract eyeglasses and contact lenses are excluded from Stark II coverage, according to a final rule released last week by the Department of Health and Human Services. The American Society of Cataract and Refractive Surgery and the American Academy of Ophthalmology have been fighting hard for this exemption since the enactment of Stark II and the subsequent release of proposed regulations that would have put ophthalmologists who referred cataract patients to their own optical shops at risk of violating Stark II’s prohibitions on self-referrals. The agency also clarified that physicians can refer patients to ambulatory surgery centers in which they have a financial interest, and that intraocular lenses or other prosthetic devices implanted in ASCs are also excluded from Stark II coverage. The implementation of this first phase of the Stark II final rule begins in a year. For more information, visit http://www.ascrs.org.

Visx, B&L end patent feud

Visx Inc. and Bausch & Lomb concluded their refractive excimer laser patent infringement litigation, entering a settlement and licensing agreement on Friday. According to the terms of the licensing agreement, Visx will license its excimer laser vision correction patents, including U.S. patent 5,108,388, to B&L; B&L will license its excimer laser vision correction patents to Visx, and will pay a royalty to Visx for each procedure performed in the United States using B&L’s excimer lasers. Neither party will license to the other any patents related to wavefront diagnostics. Further terms of the agreement are confidential, the companies announced.

Lasik Vision to receive $7 million financing, new CEO

Lasik Vision Corp. announced Wednesday that it reached an agreement for a $7 million (Canadian) private placement from John Porter, a company director. The financing includes shares, warrants to purchase additional shares, and a $3 million loan. It is the second financing arrangement with Porter, who is also founder and director of the European optical retailer Grand Vision SA. “The company has to get over the debt position and get its balance sheet with a better appearance before it can continue to expand,” Lasik Vision representative Stephen Smith said. The financing is subject to approval from the Canadian Venture Exchange; a closing of a portion of the private placement of common shares is subject to the approval of company shareholders.

Under the terms of the agreement, Hugo Sutton, MD, chief executive officer, will be replaced by Neville Fridge, who will assume the positions of president and CEO.

Introducing Novartis Ophthalmics

Novartis Ophthalmics completed its transition from Ciba Vision last week, becoming a separate ophthalmic unit operating under the pharmaceutical division of Novartis AG. “This new alignment with the pharmaceutical division will provide us with greater synergies and R&D resources to draw upon in our quest to provide the most innovative eye health products in the industry,” Luzi von Bidder, worldwide head of the new company, said. The North American headquarters for Novartis Ophthalmics will be located in Atlanta, site of Ciba Vision’s headquarters. Ciba Vision will be dedicated to contact lens and ophthalmic surgical products. Further coverage of the transition will be featured in the February issue of EyeWorld.

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BRIEFS: Rep. Nancy Johnson (R-Conn.) will likely chair the House Ways & Means Health Subcommittee. Johnson has said her priorities include Medicare reform, funding for Medicare+Choice, and a drug prescription benefit. ... Asclepion-Meditec AG’s fiscal 2000 vision unit sales were up 45%, to Euro 26.2 million; the fiscal 2000 revenue was up 22%, to Euro 41.9 million. The company is collaborating with WaveFront Sciences to develop the WASCA eye-measurement system. … The Food and Drug Administration granted approval for Escalon Medical Corp.’s diagnostic high-resolution digital camera system, the CFA Digital Imaging System. According to the company, the device uses a chip that provides 2,000-by-3,000-line resolution; images can be viewed through a personal computer for analysis and stored electronically. ... STAAR Surgical Co. received a license to market the Aquaflow collagen glaucoma drainage device in Canada for patients with uncontrolled IOP from open-angle glaucoma who have tried the maximum tolerated medical therapy. ... NovaStaar Investments announced it had requested that David Bailey, Staar president/CEO, call a special shareholders’ meeting to nominate a new board. At press time, there had been no announcement that such a meeting had been set. … The board of Prime Medical Services Inc. authorized spending an additional $10 million to repurchase shares of its common stock, expanding the company’s buyback program to $45 million. … The FDA will continue its pre-announced inspection program as standard practice for medical device inspections, but these initiatives will be up to the discretion of district management, with respect to inspections of other program areas. ... President-elect Bush’s transition team includes the chairman of Merck and people affiliated with hospital associations and the lobbying organizations for the pharmaceutical and biotech industries.