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CIBA Vision Acquires Rights to Presby Technology
Agreement Includes Implant Treatment for Presbyopia.

CIBA Vision has signed an agreement with Dallas-based Presby Corp for the exclusive worldwide license, marketing and distribution rights to Presby's portfolio of ophthalmic surgical products, including its applications for use in the treatment of presbyopia, ocular hypertension and primary open-angle glaucoma.

In addition, CIBA Vision has agreed to assume responsibility for manufacturing Presby's products and to further invest in the company if specific milestones are met.

The license agreement includes the worldwide rights to market and sell Presby Corp's scleral expansion implants, as well as a specialized automated incision device and blades. These products are used in a surgical technique for the treatment of presbyopia. The treatment is currently in clinical trials in the United States, but may be approved for use in Europe and Canada as early as this year.

In this photo, a Presby scleral expansion implant is about to be inserted through a small incision.

In performing the treatment, the scleral expansion implants are inserted within the sclera in a minimally invasive outpatient procedure using local anesthesia. The addition of the implants re-establishes the anterior segment spacing as it's found in a nonpresbyopic eye. In clinical trials, patients have reported improved near vision almost immediately after the procedure, according to Presby Corp.

In addition to the procedure's effect on presbyopia, a Canadian study shows promising early results that the implants can be successfully used to treat ocular hypertension and primary open-angle glaucoma. For glaucoma, the study indicates that the implants work by increasing the aqueous humor outflow, thus reducing intraocular pressure.

"We have evaluated the data associated with the latest design of the (Presby) technology and are confident that this is a viable product," said Robin Terrell, president of CIBA Vision's Surgical Business Unit. "The latest information that the implant can be successfully used to treat glaucoma only served to magnify our interest in this technology."

"CIBA Vision's financial and intellectual backing will allow us to fully optimize the potential of this technology, and we will work closely with CIBA Vision even as we continue our development of other innovative products for the treatment of eye disorders," said Presby Corp CEO Ronald Schachar, M.D., Ph.D.

CK Gets OK for Hyperopia
Refractec Procedure Is Approved by the FDA.

The FDA has approved a procedure developed by Refractec Inc. for treating hyperopia in people over the age of 40 through the controlled release of radio frequency energy. The minimally invasive Conductive Keratoplasty (CK) procedure takes 3 minutes to perform and can be done in a physician's office with only topical anesthesia.

During the CK procedure, radio frequency energy is applied to the eye through a tiny probe as thin as a human hair. The energy constricts the corneal tissue, which steepens the cornea and increases the curvature of the eye. The Refractec Viewpoint CK system is approved for the temporary reduction of spherical hyperopia in patients who have 0.75D to 3.25D of cycloplegic spherical hyperopia, with less than or equal to 0.75D of refractive astigmatism and a cycloplegic spherical equivalent of 0.75D to 3.00 D.

"CK meets the needs of patients who've been waiting for a safe, effective, less-invasive treatment for farsightedness," says Robert K. Maloney, M.D., director of the Maloney-Seibel Vision Institute in Santa Monica, Calif.

Due to the flatness of the cornea, hyperopia is the most difficult refractive error to treat with LASIK.

Refractec Inc. and Ophthalmology Management will sponsor a free breakfast seminar on CK at the ASCRS meeting in Philadelphia. The seminar will be held from 6:30 to 7:45 a.m. on June 2 at the Philadelphia Marriott, Rooms 302 and 304.

Visudyne Is Denied Coverage for "Occult" AMD
CMS Reverses Its Earlier Intention to Approve Treatment.

The U.S. Centers for Medicare and Medicaid Services (CMS) won't provide national coverage of patients who receive treatment with verteporfin for injection (Visudyne) for the "occult" form of wet age-related macular degeneration (AMD). The decision is a setback for the drug's co-developers, QLT Inc. and Novartis, but doesn't affect CMS national coverage for Visudyne in the treatment of the "classic" form of AMD.

In making its ruling, CMS said "the scientific evidence is not adequate" to conclude that Visudyne is clinically effective in treating the occult form of AMD. Last October, CMS had indicated it intended to cover Visudyne therapy for occult AMD, based on a clinical trial that showed the drug slowed the progression of vision loss in those afflicted with the disease. But the CMS reconsidered its decision after reviewing methodologic issues and statistical data related to the clinical trial upon which it had based its initial analysis.

"People in the ophthalmic community are very disappointed in the CMS decision because it seems to leave patients in a lurch and because the negative decision was not signaled earlier," says William A. Sarraille, a partner in the Washington, D.C., law firm of Arent Fox, which represents clients in healthcare coverage issues.

A spokesperson for QLT said the company believes the data from the clinical trial is still valid and has asked CMS to reconsider its latest decision. QLT has estimated that there are approximately 200,000 patients worldwide with the occult form of wet AMD that could benefit from Visudyne treatment. The ruling caused QLT to trim its 2002 revenue estimate from a $275 to $350 million range to a $275 to $300 million range.

LASIK Still Dominates Refractive Surgery
But Survey Sees Bright Futures for LASEK, CLE and Phakic IOLs.

LASIK is still by far the most popular procedure among U.S. refractive surgeons, with a large majority saying it's their surgery of choice for refractive errors between -12 and +3D. However, more surgeons are now choosing clear lens extraction (CLE) to treat patients with hyperopia greater than +3D.

These are some of the key findings of the fifth annual "U.S. Trends in Refractive Surgery" survey, sponsored by the International Society of Refractive Surgery (ISRS) and conducted by Richard J. Duffey, M.D., and David Leaming, M.D. The 2001 survey evaluated responses received from 188 practicing refractive surgeons, representing about 19% of the total ISRS membership in the United States.

The survey found that while LASIK remains the dominant refractive procedure, performed by 97% of the survey respondents, more than 75% of those who replied said they are either now performing, or are interested in performing each of the following procedures: CLE, LASEK and Phakic IOL implants. These numbers represent significant increases in interest in these procedures.

But while 76% of the survey respondents said they had an interest in LASEK, only about 20% said they are currently offering it to patients.

Dr. Duffey told Ophthalmology Management that one of the findings he found most interesting in the latest survey is that refractive surgeons have almost universally adopted the practice of performing bilateral LASIK during a single visit.

"Greater than 98% of ISRS members now do bilateral LASIK during one visit, as compared to 64% in 1997, the first year of our survey," says Dr. Duffey.

Among other survey findings:

• The VISX Star laser is still preferred by 2 to 1 over all other excimer lasers combined.
• More than 80% of respondents co-manage refractive surgery patients, predominantly with optometrists.

IN THE NEWS

Collective negotiations. A bill has been introduced in the House of Representatives that would improve physicians' ability to collectively negotiate with private health plans. The Health Care Antitrust Improvement Act of 2002 calls for the creation of several pilot programs that would enable physicians to engage in binding negotiations with insurers to set the terms and types of medical services provided to patients.

Failed trial. Vitrase, a drug developed by ISTA Pharmaceutical to treat severe vitreous hemorrhage, failed to meet its primary goal in a Phase III clinical trial. Though the drug didn't clear hemorrhages enough to allow diagnosis and treatment of the underlying cause of the bleeding, it did decrease the density of hemorrhages and improve visual acuity.

Akorn patent. Akorn Inc. has received a U.S. patent for diagnosing and treating abnormal vasculature using fluorescent dye angiography and dye-enhanced photocoagulation. The patent covers a method for enhancing the clarity of indocyanine green angiograms to allow more precise laser treatment of choroidal neovascularization associated with AMD.

New facility. Advanced Vision Research, which researches and develops dry eye treatment, has opened a second facility for the manufacture of its TheraTears Lubricant Eye Drops. The new facility triples production capacity.

Acuvue benefit. The FDA has granted Vistakon clearance to revise the labeling on its 1-Day Acuvue soft contact lenses to indicate that the lenses, when worn on a daily disposable basis, may provide improved comfort for patients with mild allergic discomfort and ocular itching. The new claim is based on a recent clinical study.

Trial delayed. Eli Lilly and Co. has delayed by 4 to 6 months a key Phase III clinical trial for a new drug for treating ocular complications of diabetes, including macular edema and diabetic retinopathy. A Lilly spokesperson said the delay is due to creating the criteria for the trial and not the result of safety or efficacy issues. The drug, known by the code LY333531, targets a family of proteins known as Protein Kinase C that play an important role in sending signals between cells.

Appointed. Ocular Sciences has named Gary Paladin to the new position of president of global marketing. Paladin, who has 16 years of marketing experience within the healthcare and consumer products industry, will focus on developing the contact lens maker's strategic marketing initiatives on a worldwide basis.

Retired. Jacques Stoerr, the longtime leader of Essilor of America, has retired as chairman of the company. Stoerr, whose tenure with the company has spanned more than 35 years, will continue as an adviser on VisionWeb and other Essilor projects.

Awareness campaign. Vistakon has launched a campaign to educate Hispanic-Americans on the importance of vision care, a health issue that's often neglected by this community because of the lack of Spanish-language eye health information. As part of the campaign, a network of Spanish-speaking eyecare professionals has been formed to provide information at the community level. Vistakon is also launching a Spanish-language eyecare Web site and will sponsor Hispanic festivals in Miami, Los Angeles and New York. Hispanics age 40 and older are at high risk for developing glaucoma and diabetic retinopathy.

Grant received. Lighthouse International has received a $150,000 grant from the AARP Andrus Foundation to develop and implement an eyecare awareness campaign for older Americans. The campaign, called "The Aging Eye and You," will focus on promoting the quality of life among older people at risk for - or who already have - chronic vision impairment.

UltraVac. STAAR Surgical has introduced UltraVac V1 coiled tubing designed to improve the efficiency and safety of venturi-type phaco systems manufactured by Bausch & Lomb. Combined with a proprietary phaco cassette, the new tubing allows the surgeon to increase vacuum during surgery while achieving anterior chamber stability.

Acquisition. Vision Pharmaceuticals, which markets Viva-Drops for dry eye through ophthalmologists, optometrists and retail outlets, has been acquired by Corneal Sciences Corp., a privately owned pharmaceuticals company.

REFRACTIVE SURGERY UPDATE

Army OKs LASIK. The U.S. Army has done an about-face regarding its policy on soldiers having LASIK. Just 2 years ago, soldiers who had undergone refractive surgery were deemed unfit for active duty because of fear that their flaps could tear under rugged conditions. But a Department of Defense medical panel reversed that policy last year, saying that soldiers would be better able to perform their duties if they didn't have to worry about glasses fogging up or contacts popping out during combat or other dangerous situations. The Army is now funding a program to provide LASIK for members of its elite Special Forces and frontline infantry units.

Approvals predicted. Bausch & Lomb recently predicted that its Technolas 217 laser will be approved for treatment of hyperopia by mid-year, and that its Zyoptix system for customized refractive surgery will receive approval before the end of this year.

Stock fraud alleged. The Securities and Exchange Commission has charged J.T. Lin, the former chairman of laser developer SurgiLight Inc., of profiting from a multimillion dollar stock manipulation scheme that artificially inflated the price of SurgiLight shares, allowing Lin and his wife to sell shares and make $1.7 million in illegal profits. According to the SEC, the scheme involved the issuance of "false and misleading" company press releases touting an untested SurgiLight treatment for presbyopia. The company noted that its current management team took over corporate responsibilities "long after" the alleged acts occurred.

VISX sales. VISX Inc., a leading developer of excimer lasers for vision correction, reported overall revenue of almost $36.5 million for the 3 months ending March 31, an increase of more than 20% over the previous quarter. OM Licensing revenue was 35% greater than the December quarter due to a pickup in procedure volume.

CK study. A 1-year study of 54 eyes which had undergone conductive keratoplasty for low-to-moderate hyperopia showed that in terms of safety, effectiveness and stability the procedure produced results "as good or better" than those achieved by LASIK or laser thermal keratoplasty. Conductive keratoplasty uses a low-energy, high-frequency current applied directly into treatment spots in the peripheral corneal stroma.

Departs. Thomas G. O'Hare has left his position as president and chief operating officer of TLC Laser Eye Centers Inc. O'Hare's departure paves the way for James Wachtman, currently president and COO of Laser Vision Centers Inc., to assume the same post in the new company that will be formed through the combination of TLC and Laser Vision.