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FDA Ophthalmic Devices Panel Recommends STAAR ICL Approval
Endothelial Cell Loss Is a Concern.

In a landmark 8-3 vote, the FDA Ophthalmic Devices Panel has recommended approval of STAAR Surgical's Implantable Contact Lens (ICL) for treatment of myopia from -3D to -20D in patients as young as 21. The ICL is the first phakic IOL to ever come before the panel.

If the FDA concurs with the panel's decision, the ICL could be commercially available early next year, offering an entirely new option for correcting myopia. STAAR says its target market is individuals age 21 to 45 with moderate to severe myopia. As you know, severe myopes aren't good candidates for LASIK.

Though the groundbreaking vote is considered a significant win for STAAR, the panel's approval recommendation comes with certain conditions.

STAAR Surgical's ICL

The panel expressed concern about the potential for endothelial cell loss over the long term and recommended that patients have an endothelial cell count before surgery to determine if their cell count is high enough to qualify for the procedure. If the ICL is approved, annual endothelial cell counts over a multi-year follow-up period might also be required, though that issue is part of STAAR's discussion with the FDA. The requirement for annual cell counts could add costs to the procedure for patients, and would mean that all surgeons implanting the ICL would have to have specular microscopes and automated cell counters to determine endothelial cell density.

The panel said additional data is needed to validate STAAR's contention that endothelial cell loss stabilizes after 3 to 4 years. By a 6-5 vote, the panel urged the FDA to continue to monitor endothelial cell loss each year for 5 years in some of the patients who took part in the ICL clinical trial. One of the arguments made by panel members who voted against approval of the ICL was that longer-term data on endothelial cell loss should be obtained before the lens is allowed to become commercially available.

"We're extremely pleased with the panel's recommendation and vote of confidence, and we look forward to working with the FDA staff to complete the review of the ICL," said David Bailey, president and CEO of STAAR Surgical. "The panel recommendation comes after the presentation of significant data that demonstrated extremely high patient satisfaction levels with the ICL, as well as excellent post-operative visual acuity."

The posterior-chamber STAAR ICL was redesigned with a higher vault after earlier studies showed a significant rate of cataract formation in patients who received the lens. The latest trial indicates that the cataract issue has been addressed.

REFRACTIVE SURGERY UPDATE

CK for presbyopia. Refractec Inc. has filed a Pre-Market Approval application with the FDA for its CK Blended Vision procedure for presbyopia, making it the first procedure specifically for presbyopia to be reviewed by the FDA. Refractec CK -- or Conductive Keratoplasty -- has already been approved for the treatment of moderate hyperopia in patients over the age of 40 and has in 18 months captured significant market share in its approved range.

The minimally invasive CK Blended Vision procedure takes about 3 minutes and uses radio waves to restore patients' near vision without impacting their distance vision. Refractec says the procedure has one of the highest safety profiles in the refractive market.

"The treatment of presbyopia is the final mile in vision correction," says Marguerite B. McDonald, M.D., clinical professor of ophthalmology at Tulane University, director of the Southern Vision Institute in New Orleans, and medical monitor for Refractec. "Prior to CK, the only option baby boomers had outside of invasive surgery was age-defining 'granny glasses' or special contacts, both of which have a high hassle factor and are considered by many to be a handicap of aging."

In clinical studies, 97% of patients could see 20/20 at distance and read magazine- and newspaper-size print, while 75% of patients could see 20/20 at distance and read smaller phone book-size print. And 96% of patients reported being satisfied with their outcome.

The clinical trial data indicated that depth perception and ability to see contrast in day and night conditions were both relatively unaffected by the CK Blended Vision procedure, according to Daniel S. Durrie, M.D., associate clinical professor, University of Kansas, and medical monitor for the study.

Refractec said it anticipates FDA pre-market approval for the new indication early next year.

IN THE NEWS

Acquisition. Allergan has announced an agreement to purchase privately held Oculex Pharmaceuticals for approximately $230 million in cash. Oculex, which developed a proprietary biodegradable drug delivery technology, has been conducting research on back-of-the-eye diseases with Allergan since 2001. The Oculex lead investigational product is Posurdex for the treatment of macular edema, which is expected to begin Phase III clinical trials early next year.

ASC reimbursement study. The Office of Inspector General (OIG) for the U.S. Department of Health and Human Services said it plans to review the costs and payments associated with ASC procedures as part of its 2004 agenda.

The information gathered will be provided to the Centers for Medicare and Medicaid Services (CMS) to help CMS determine if current reimbursement rates for surgery centers are reasonable, or need revision. The review was expected, as CMS hasn't gathered ASC cost and charge data in more than a decade. A wide disparity exists between ASC and hospital reimbursement for some high-volume ophthalmic procedures.

Patent decision. The European Patent Office has revoked a CIBA Vision contact lens patent that had been used as the basis for a German court decision prohibiting the sale of Bausch & Lomb's 30-day-and-night PureVision lenses in that country. B&L said it will now seek to resume sales of the lenses in Germany. A CIBA Vision spokesperson said the company will appeal the decision.

B&L marks 150 years. Bausch & Lomb begins the celebration of its 150th anniversary as a continuously operating company this month. The company, started by John Jacob Bausch as a small optical shop in Rochester, N.Y., in 1853, is planning a number of activities and events throughout the next year to mark this important milestone.

Therapeutic lenses available. Following the recent approval of CIBA Vision's Focus Night and Day contact lenses for therapeutic use by both the FDA and Health Canada, the company has made the lenses available in the United States and Canada in plano. The 30-day-and-night extended-wear lenses, which supply up to six times more oxygen to the eye than ordinary contact lenses, can be used as a bandage to protect the cornea and relieve corneal pain in the treatment of acute or chronic ocular pathologies following eye surgery.

Because of Night and Day's high oxygen transmission, the full lens power range can also be used in therapeutic applications where vision correction is required.

Fast-track for Visudyne. The FDA has granted fast-track review status to Visudyne therapy for both occult with no classic and minimally classic subfoveal choroidal neovascularization (CNV) due to AMD. Fast-track status is granted to drugs intended for the treatment of a serious or a life-threatening condition and which demonstrate the potential to address unmet medical needs for such a condition.

In a related development, Visudyne has been approved in Japan for treatment of AMD with all types of subfoveal CNV.

Glaucoma survey. A survey of more than 4,000 glaucoma patients conducted by the Glaucoma Research Foundation found that about 40% of the patients didn't know that glaucoma can lead to blindness; 10% of the respondents felt that they don't get enough information from their doctors; and 60% of those patients who had switched physicians cited poor communication as their reason.

ISTA NDA accepted. ISTA Pharmaceuticals said the FDA has accepted the company's New Drug Application (NDA) seeking approval for the use of ovine hyaluronidase (Vitrase) as a spreading agent to facilitate the dispersion and absorption of other drugs, particularly in cataract surgery.

In a similar development, Amphastar Pharmaceuticals said the FDA had accepted its application for the use of hyaluronidase injection (Amphadase) as an agent to facilitate the dispersal and absorption of other drugs, with applications in cataract surgery.

If approved, Vitrase and/or Amphadase could take the place of the now-discontinued bovine hyaluronidase (Wydase) to disperse anesthesia during cataract surgery. Production of Wydase ended after its maker, Wyeth-Ayerst Laboratories, declined to replace the aging manufacturing facility in which the drug was produced.

Humanitarian use. Intacs prescription inserts have received Humanitarian Use Designation (HUD) for use in certain keratoconus patients. The HUD is for reduction or elimination of myopia and astigmatism in patients who can't achieve functional vision with contact lenses or glasses.

FDA Approves Bausch & Lomb's Zyoptix System for Custom Ablation
The B&L System Receives Widest Treatment Range.

In early October, Bausch & Lomb received FDA approval for marketing its Technolas 217z Zyoptix system for performing custom LASIK. The Zyoptix system was given the widest treatment range of any of the three custom systems approved for use in the United States: up to -7D of myopia with up to -3D of astigmatism and manifest refraction spherical equivalent equal to or less than -7.50D.

The Zyoptix platform, which combines an upgraded B&L Technolas 217 excimer laser with a Zyoptix diagnostic workstation and Zylink treatment software, has been in use internationally since 2001. According to Bausch & Lomb, approximately 100,000 custom procedures have already been performed with this system.

"With the Zyoptix system, we found that about 40% of patients reported having better night driving vision than they did before surgery, which, in my experience, is an unprecedented result," added Scott M. MacRae, M.D., professor of ophthalmology at the University of Rochester Medical Center in New York state.

The U.S. clinical study for Zyoptix encompassed 340 eyes with a combination of myopia and astigmatism. After surgery, 91.5% of patients had uncorrected visual acuity of 20/20 or better, and 70.3% of patients had uncorrected visual acuity of 20/16 or better. More than 94% of the patients in the study maintained or improved their best-corrected vision 6 months post-operatively, and 99% reported that they were satisfied with the results.

The Zyoptix system joins the VISX CustomVue system, which received FDA approval in May, and the Alcon CustomCornea system, approved in December 2002, as platforms U.S. surgeons can now use to perform personalized laser vision correction.

House Members Form Vision Caucus
The Goal Is to Raise Eye Care Funding and Awareness.

With a big assist from the American Academy of Ophthalmology (AAO), Prevent Blindness America, and a number of other organizations dedicated to advancing public eye health, several members of Congress have launched the Congressional Vision Caucus.

The new group has been formed to raise public and congressional awareness about the importance of funding both basic research to find new treatments for eye diseases and public health education efforts, such as eye exams for diabetics.

"The public needs to understand that most blindness is preventable through early intervention," said H. Dunbar Hoskins, Jr., M.D., AAO executive vice president. "This caucus will be the key to our mission to ensure that the public has access to the best possible eye care."

Dr. Hoskins said the U.S. Department of Health and Human Services (HHS) has declared vision health a top federal initiative in its Healthy People 2010 report, noting that 80 million Americans have a potentially blinding eye disease.

The AAO estimates that more than a million Americans have glaucoma but don't know it, and that almost half of the approximately 5.3 million Americans who have diabetic retinopathy aren't getting their eyes examined. According to HHS figures, people with these, and other, eye conditions are costing the federal government $4 billion a year in direct and indirect costs.

The four founding members of the Congressional Vision Caucus -- Reps. Gene Green (D-Texas), Patrick Tiberi (R-Ohio), David Price (D-N.C.) and Ileana Ros-Lehtinen (R-Fla) -- have all expressed special interest in vision-related issues. The husband of Rep. Ros-Lehtinen lost vision in one eye due to a wound he received while serving in Vietnam, while the mother of Rep. Price has glaucoma.

The AAO expects to help shape the caucus agenda, participate in Capitol Hill briefings, and secure co-sponsors for legislation.

First European Laser Gets FDA OK
Allegretto Wave had Excellent Outcomes.

The FDA has approved the Allegretto Wave, a German-made excimer laser system, for the treatment of both myopia and hyperopia. The approved correction range is for myopia up to -12D, with astigmatism up to -6D, and for hyperopia up to +6D, with astigmatism up to +5D.

The Allegretto Wave, which will have its U.S. launch at this month's American Academy of Ophthalmology meeting, has been in wide international use for the past 3 years, with about 260 systems sold. It was developed by Wavelight Laser Technologie AG of Erlangen, Germany, and will be distributed in the United States by Lumenis.

The Allegretto Wave System

"The FDA approval for the Allegretto Wave is the most important milestone that we have reached this year, and one of the most important ones in our overall company history," said Max Reindl, founder and chairman of WaveLight Laser Technologie.

Though the Allegretto isn't specifically designed to perform custom ablation, Lumenis director of refractive sales Mike Shuler says the systems produces a wavefront-optimized ablation profile for each patient, providing what is essentially a customized treatment from a standard platform. Surgeons have praised the system for producing impressive visual acuity gains, decreases in night vision problems and predictable results.

One reason for the Allegretto's superior results has been cited by Jack Holladay, M.D., M.S.E.E., F.A.C.S., clinical professor of ophthalmology at Baylor College of Medicine in Houston, Texas. Dr. Holladay says the Allegretto is designed to perform an ablation that's accurate all the way to the periphery of the ablation zone.

The Allegretto system underwent 3 years of U.S. clinical trials at 11 sites. Of the 844 eyes treated for myopia, 98% had stable uncorrected visual acuity of 20/40 or better after 3 months, and 84.4% achieved 20/20 or better. In 287 hyperopic eyes, 98.7% were 20/40 or better after 1 year and 67.5% achieved 20/20 or better.

Results of Posterior Uveitis Trial Are Mixed
Implant Shows Efficacy, but Safety Issues Arise.

An analysis of 34-week data from a Phase III clinical trial using Bausch & Lomb's Retisert intravitreal drug delivery implant for the treatment of non-infectious posterior uveitis indicates that the implant is effective, but with a high incidence of side effects.

Retisert is a tiny drug reservoir designed to deliver sustained and consistent levels of the steroid fluocinolone acetonide directly to the back of the eye for up to 3 years.

In the trial, 278 patients were randomized to receive either a 0.5-mg or 2-mg Retisert implant in the affected eye, or in bilateral cases, in the most seriously afflicted eye. The fellow eye was left implant free.

Lead investigator Glenn Jaffe, M.D., professor of ophthalmology, Vitreoretinal Diseases and Surgery, at the Duke University Eye Center, reported that at 34 weeks the uveitis recurrence rate was 2.9% in those eyes with the Retisert implant compared to a 43.7% recurrence rate in the fellow eyes. The implant eyes also showed a statistically significant improvement in visual acuity, with 25.9% of the implant eyes showing an improvement of three or more lines. There was no statistically significant change in mean visual acuity in the fellow eyes.

In terms of safety outcomes, Dr. Jaffe reported that the most common adverse events included cataract progression and increased IOP. Investigators said these events were anticipated, given the nature of the disease and the type of drug used.

At 34 weeks, eye drops to control elevated IOP were being used in 34.9% of the implant eyes and 11.5% of the fellow eyes, compared to 8.6% of the implant eyes and 6.8% of the fellow eyes at enrollment. Filtering procedures were needed to control IOP in 8.6% of the implant eyes.