At Press Time
Panel OK's First Accommodative IOL
C&C Vision's CrystaLens Gets Unanimous Recommendation.

In a milestone decision, the FDA Ophthalmic Devices Panel has voted unanimously to give the first "approvable" recommendation to an accommodative IOL. The panel recommended that C&C Vision's CrystaLens could be implanted in adults following cataract removal. Pending final approval by the FDA, the lens is expected to enter the U.S. marketplace by the end of this year.

C&C Vision's CrystaLens

The panel determined that the CrystaLens improves near, intermediate and far vision for patients who want to reduce or eliminate the need for glasses. But because the exact amount of accommodation the CrystaLens creates through the contraction of the ciliary muscle is impossible to measure accurately, the panel recommended labeling the lens as providing 1D of accommodation. C&C Vision says clinical data showed significantly higher amplitudes of accommodation, with 97.6% of patients able to read J2 or better.

This is just one of several labeling issues that the company and the FDA are now working to resolve.

If it receives final approval, the CrystaLens will compete against the monofocal and multifocal lenses that are typically implanted after cataract surgery.

"We intend to market CrystaLens alone, with no partner," says MaryAnn Tingley, director of marketing for C&C Vision. "We have specific protocols that must be followed in using this lens and we want to provide complete education to surgeons. CrystaLens is a unique product because implanting the lens combines basic cataract surgery and pre- and post-operative testing that closely monitors refractive outcomes."

Tingley says most surgeons can implant the foldable CrystaLens, which is made of a third-generation silicone, through a 3.5- to 3.7-mm incision (an injector is being developed). To obtain accurate measurements, surgeons must perform immersion biometry, or axial length measurements using the IOLMaster with third-generation software. They should also do manual keratometry prior to implanting the lens.

C&C Vision submitted 1-year clinical data to the FDA in support of its Pre-Market Approval application. Seventeen investigators enrolled a total of 497 eyes between February 2000 and November 2001.

The lens is already a proven product internationally. It has the CE mark, with more than 4,000 eyes implanted worldwide in recent years. The cost of the lens in the markets where's it's already been approved is approximately US$800.

The panel's favorable recommendation of the CrystaLens marks the culmination of 14 years of work for J. Stuart Cumming, M.D., the developer of the lens.

Generic Brimonidine Tartrate 0.2%: Does it Compare to Alphagan P?
Allergan and B&L Debate Its Side Effects Profile.

The FDA has approved Bausch & Lomb's Abbreviated New Drug Application to market brimonidine tartrate ophthalmic solution 0.2%, a generic form of Allergan's glaucoma medication Alphagan. Bausch & Lomb said it would make the generic drug available immediately.

Louis Cantor, M.D., professor of ophthalmology and director of the glaucoma service at the Indiana University School of Medicine in Indianapolis, says Alphagan P "offers a substantial improvement and advancement, primarily in the area of tolerability." He called Alphagan "a product that has been surpassed by a better one."

Dr. Cantor says the generic form of Alphagan will "have a role, based on the initial cost issue."

However, he contends that managed care plans and state formularies that adopt the generic product will be using short-term thinking.

"Every additional episode of ocular allergy calls for an unscheduled visit to a physician, plus follow-up visits."

Gary Phillips, M.D., corporate vice president for global pharmaceuticals, Bausch & Lomb, says several studies comparing the side effect profiles of generic Alphagan and Alphagan P arrive at different conclusions.

"We see our generic and Alphagan P as equivalent products," says Dr. Phillips. He cites an FDA report comparing the two medications, which states: "We find any differences in study results between the two products to be typical of the variability seen in clinical trials and do not find the differences in this case to be clinically significant."

Adds Dr. Phillips: "With the approval of our generic, patients can now go back to a product that they're familiar with, and at a lower cost." 

IN THE NEWS

New formulation approved. The FDA has approved Allergan's ketorolac tromethamine ophthalmic solution 0.4% (Acular LS) for reducing ocular pain, burning and stinging following corneal refractive surgery.

Omega-3 for dry eye. Advanced Vision Research said a recent study conducted by investigators from the Harvard Medical School and Schepens Eye Research Institute has confirmed a link between low Omega-3 intake and dry eye. To help combat this deficiency and decrease the risk of dry eye syndrome, Advanced Vision Research recently introduced TheraTears Nutrition for Dry Eyes, an Omega-3 supplement.

Zymar off to quick start. Allergan's recently approved fluoroquinolone, gatifloxacin 0.3% (Zymar), accounted for 13.1% of all ophthalmic fluoroquinolone prescriptions written within ophthalmology during the last week of May, according to audited data released by Verispan, which tracks prescriptions on a weekly basis.

"The quick uptake of Zymar is due to the superior efficacy of fourth-generation fluoroquinolones, and Zymar's particular effectiveness against gram-positive pathogens and atypical organisms, as well as its superior pseudomonal coverage," said Jane Wolf, senior product manager for Allergan.

Speedier approval of generics. The FDA has implemented a proposal to allow earlier introduction of generic versions of drugs. The regulations limit drug manufacturers to one 30-month "stay" of a generic's entry into the market while a patent challenge is resolved.

Alcon Tests New Type of IOL
ReSTOR Lens Is Called a "Pseudoaccommodative."

Alcon has been quietly testing what it terms a "pseudoaccommodative vision" IOL called the AcrySof ReSTOR lens for about the past 18 months. Unlike some recently developed accommodative lenses also designed to treat presbyopia in aphakic patients, the ReSTOR lens is stable in the eye and doesn't depend on the contraction of the ciliary muscle to move the lens to create an accommodative effect.

The AcrySof ReSTOR IOL

Because clinical studies are ongoing, Alcon hasn't yet released detailed visual acuity results. However, the company told Ophthalmology Management that since December of 2001, approximately 300 of the acrylic co-polymer AcrySof ReSTOR lenses have been implanted in the United States and about another 127 internationally. Alcon says early results are very promising, with significant improvement in mean near vision and a reduction in the incidence of glare, halos and difficulty with night vision.

According to Alcon, the ReSTOR utilizes a proprietary process technology combining diffractive and refractive optics, which results in quality near and distance vision. The central 3.6- mm diffractive region provides both near and distance vision that gradually blends to the refractive portion of the optic through a controlled step height reduction moving toward the periphery. This blending process is called apodization. Light energy is equally divided between the near and distance for small pupils and gradually becomes distance-dominant in low lighting/large pupil conditions.

The ReSTOR lens uses the principle of diffraction to create circular wavelets of light, which form a designed wavefront. The apodized diffractive portion provides a +4.0 add power for near vision. The step height determines the intensity, and the step spacing determines the add power. These steps coordinate near and distance vision.

Alcon believes that the low incidence of glare and halos with the ReSTOR lens are in part due to the apodization structure. In addition, the size and power of the zone also help to minimize unwanted photic phenomena. Alcon says the combination of these factors creates the energy blend between the near and distance focus.

Patients Unaware of OTC Tear Issues
Some Drops May Undo the Benefits of a New Medication.

Preservative-free OTC dry eye drops may be safer and more effective than familiar, brand-name drops such as Visine, according to John Sheppard, M.D., and Joe Vehige, O.D., senior director of consumer eyecare research and development at Allergan.

Speaking at a recent Allergan press conference, the two doctors noted that educating patients could do a lot to prevent ineffective or harmful self medication.

Drs. Vehige and Sheppard recommend the Refresh line of products for patients with dry eye. They cited two primary reasons. First, the active ingredient in the Refresh products, carboxymethyl cellulose polymer (CMC), binds to the ocular surface, forming a barrier against irritation.

Second, the Refresh products that are preserved are preserved with Purite, an oxidative preservative that breaks down into components of natural tears upon exposure to light. Purite is well-tolerated and doesn't appear to cause long-term ocular surface damage, they said.

Dr. Sheppard said it's important to recommend the right product for each patient's needs, especially for patients who use the new prescription dry eye drop Restasis and also require adjunct therapy. Using Refresh prevents the undoing of some of the benefits of the preservative-free Restasis drops, he said.

The speakers offered another suggestion, as well: When treating dry eye and related issues, keep treatment variables to a minimum. Treat one condition at a time, with one medication at a time, so you can tell what response you're getting to which treatment.

IN THE NEWS

Fighting ASC fee cuts. The American Academy of Ophthalmology and the Outpatient Ophthalmic Surgery Society have begun a lobbying effort aimed at persuading Congress to soften recommendations from the Medicare Payment Advisory Committee (MedPAC) relating to payments for procedures performed in ASCs. In addition to recommending an overall freeze on ASC payment levels in 2004, MedPAC has called for reimbursement for all procedures performed in ASCs to be no higher than the hospital outpatient payment for the same procedure. Congress is expected to consider these recommendations in its deliberations on a Medicare reform bill.

Occult AMD treatment. Iridex said two studies using the company's OcuLight SLx laser have further validated the effectiveness of transpupillary thermotherapy (TTT) for the treatment of occult wet AMD. In an Arizona study, 71% of patients with predominantly occult AMD treated with TTT demonstrated stable or improved visual acuity at 12-month follow-up. In a Swedish study, 59.3% of patients avoided moderate vision loss at 12-month follow-up.

New medical director. ISTA Pharmaceuticals, Inc., a developer of ophthalmic drugs including Vitrase for vitreous hemorrhage, has named John W. Chandler, M.D., as the company's medical director. Dr. Chandler was previously professor and chair of the ophthalmology department at the University of Illinois, Chicago, as well as at the University of Wisconsin. Dr. Chandler has also chaired the FDA's ophthalmic devices advisory committee.

Acquisition. TLC Vision has acquired American Eye Instruments Inc. (AEI), of Gold Beach, Ore., which provides cataract surgery services to community hospitals in 12 states. In cooperation with participating ophthalmologists and optometrists, AEI helps hospitals develop cataract surgery programs using mobile equipment furnished by the company. AEI will be integrated into TLC Vision's Midwest Surgical Services unit, a leading outsource provider of cataract services.

OOSS: Cover More ASC Procedures
Medicare Reimbursement Sought Under 17 Codes.

While praising the Centers for Medicare and Medicaid Services (CMS) for making additional ophthalmic procedures eligible for Medicare reimbursement when performed in ASCs, the Outpatient Ophthalmic Surgery Society (OOSS) has asked CMS to approve a number of other procedures that the OOSS believes are also appropriate for the ASC setting.

The OOSS questioned the criteria CMS used to deny reimbursement for these procedures.

In late March, CMS approved Medicare reimbursement when billed under the appropriate CPT codes for revision of the upper and lower eyelid, correction of astigmatism, and repositioning of an intraocular lens when those procedures are performed in an ASC.

But OOSS President Jerome H. Levy, M.D., said OOSS is disappointed that CMS failed to add 17 other specific procedures. They are:

• 65286 (Repair of eye wound)
• 65436 (Curette/treat cornea)
• 65450 (Treat corneal lesion)
• 65820 (Relieve inner eye pressure)
• 65855 (Laser surgery of eye)
• 65860 (Incise inner eye adhesions)
• 66761 (Revision of iris)
• 66762 (Revision of iris)
• 66770 (Removal of inner eye lesion)
• 66820 (Incision, secondary cataract)
• 67101 (Repair, detached retina)
• 67110 (Repair detached retina)
• 67208 (Treatment of retinal lesion)
• 67343 (Release eye tissue)
• 68100 (Biopsy of eyelid lining)
• 68110 (Remove eyelid lining lesion
• 68135 (Remove eyelid lining lesion)

"These procedures are safe and appropriate for the ASC setting, and should be on the ASC list," asserted Dr. Levy. He noted that OOSS is particularly concerned by CMS reasoning for keeping these procedures off the list.

	Eyelid surgery for patients such as this woman can now be performed in ASCs. The OOSS wants 17 additional ophthalmic procedures approved for ASCs. PHOTO COURTESY OF: WWW.EYEPLASTICS.COM

According to the preamble to the March notice, these procedures aren't being added to the ASC list because they're either inconsistent with the current eligibility criteria, or overpaid in the lowest ASC payment group.

"These considerations are inappropriate, and should not be applied for purposes of making ASC list determinations at this time," Dr. Levy said.

In challenging the CMS decision, OOSS emphasized that CMS should stop using time limits on operating and recovery time as a basis for determining whether a procedure should be added to or deleted from the ASC list.

The OOSS contends that technological advances make it safe and appropriate to perform more involved, complicated procedures in the ASC setting.

REFRACTIVE SURGERY UPDATE

Icahn ends battle with VISX. After an almost 3-year saga during which billionaire financier Carl Icahn tried several ways to maximize his almost $140 million investment in VISX Inc., Icahn has sold his 6.02 million shares of the company's common stock and taken about a $20 million loss. VISX itself purchased 3.5 million of Icahn's shares.

"You can't win 'em all," said Icahn, who has had numerous successes over the years by buying large blocks of stocks in companies such as Nabisco that he rightly believed to be undervalued.

After purchasing his VISX shares in 2000, Icahn initiated a campaign to have VISX auction itself off. Icahn believed that a large company in the medical equipment industry would pay handsomely to get involved in what was then the fast-growing laser vision correction equipment industry. When that effort failed, Icahn said he would personally buy VISX himself, but that overture was deemed a ploy to generate other, higher bids. Finally, Icahn recently engineered an unsuccessful proxy fight to get one of his representatives voted onto the VISX board of directors. Having exhausted all of his options, Icahn decided to exit.

"If he had sold the shares in the open market, it could have been very disruptive," said VISX Chairman and CEO Liz Davila. "The threat is gone."

Presby merged. Presby Corp, which is developing surgical procedures for the treatment of presbyopia, primary open-angle glaucoma and ocular hypertension, has been merged into the Refocus Group of Dallas, Texas.