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February 2004
IN THIS ISSUE

CATARACT AND REFRACTIVE...


GLOBAL OPTHALMOLOGY ...


OCULAR UPDATE ...


FEATURES...

Industry Briefs
From the Editors
Bio-Ophthalmology
Regulatory Matters
Out and about
Reflections on Refractive Surgery
In your good books


Industry Briefs
Recent Developments in the Vision Care Industry

Vision companies rebounded in 2003

Most of the major companies in the refractive surgery field posted strong gains in the last year, accounting for six of the top 10 best-performing, an industry overview reveals. Some of the strongest performances were turned in by Visx, LCA-Vision, TLC Vision, Staar Surgical and ISTA Pharmaceuticals (ISTA). Improvements were also seen on the pharma side, with Alcon, Allergan, AMO and QLT all posting notable gains.

Refractec also a gainer

Refractec, the privately-held company that makes the Viewpoint CK system used to perform conductive keratoplasty, also did well last year. The company reported that it had exceeded the sales goals it had set for itself in 2003. The company received FDA approval for CK treatment of hyperopia in 2003 and hopes to gain an additional approval for treatment of presbyopia early this year.

Trouble for Staar?

The FDA expressed its displeasure with Staar Surgical over that company's handling of complaints from patients who received the Implantable Contact Lens (ICL). The company's stock plummeted when the FDA cited the company for failure to insure that complaints were investigated and reported properly. These complaints included blurred and cloudy vision. The FDA also faulted the company on some of its manufacturing safeguards. Staar issued a press release acknowledging the problems, promising that it would immediately make every effort to comply with the FDA requests.

Verisyse under review

Advanced Medical Optics (AMO) reported that the FDA shortly would review a pre-market approval application for the Verisyse phakic intraocular lens. AMO shares distribution rights with the European company that developed the lens, Ophtec. Ophtec markets the lens outside the US and Japan under its original name, the Artisan lens. AMO markets the lens globally as the Verisyse IOL.

Scleral implant studies proceed

The Refocus Group announced that it had received FDA approval for Phase II clinical trials of its scleral implants and scleral spacing procedure. The company, which partners with Ciba Vision, hopes to develop the procedures as treatments for presbyopia. The Phase II trials will enrol 100 patients at ten sites.

Bausch gaining InSite

Bausch and Lomb completed its acquisition of ISV-403/Durasite a new fourth generation fluoroquinolone and delivery system from the developer, InSite Vision Inc. Bausch and Lomb will now take over all future development and marketing expenses.

New pachymeter from Accutome

Accutome announced the global debut of a new diagnostic device, the Pach IV pachymeter. The device offers a straight or angled probe, a range of 300 to 999 microns and an accuracy of +/- 1 micron. The device includes a universal power supply in 100, 120, 220 and 240 VAC 50/60 Hz.

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