Medical Device Daily Contributing Writer

WASHINGTON – The annual Symposium on Cataract, IOL and Refractive Surgery, sponsored by the American Society of Cataract and Refractive Surgery (ASCRS; Reston, Virginia), being held at the Washington Convention Center, has drawn record attendance, reflecting the continuing surge in interest in refractive surgery devices and technologies.

Over the past several years, refractive surgery has surged to the forefront of this meeting, usurping the more mature cataract surgery market. The well-established laser in situ keratomileusis (LASIK) and photorefractive keratectomy (PRK) procedures have been supplemented by newer technologies such as conductive keratoplasty, and phakic and refractive intraocular lenses (IOLs) that have generated huge interest and a lucrative revenue stream for the ophthalmic surgery community.

According to the widely quoted market research firm Marketscope (Manchester, Missouri), excimer laser vision correction (LVC), which dominate today’s refractive market, peaked at about 1.4 million procedures in 2000 and then plunged in the economic mailaise that followed the Sept. 11, 2001, terrorist attacks on the U.S. They have gradually recovered and reached nearly 1.4 million in 2004.

Marketscope CEO Dave Harman told Medical Device Daily that he expects LVC procedures in 2005 to surpass the record number reported in 2000, fueled by rising consumer confidence and greater disposable income. He qualified that statement somewhat, however, noting that the recent slump in the stock market and rising oil prices could dent consumer confidence and slow LVC growth.

The more tepid growth of the cataract surgery market primarily reflects the fact that the number of procedures, followed by implantation of an IOL, is growing essentially in line with the increase in the over-65 age category. An estimated 2.8 million cataract procedures and IOL implants were performed in the U.S. in 2004, with about 80% occurring in the Medicare population. As such, this procedure is the most commonly reimbursed one by Medicare, consuming more than half its budget for vision care.

One of the most noteworthy changes to this year’s program was the debut of Glaucoma Day, the first time that ASCRS has dedicated a full day to this topic. The response to this new program was impressive, with a large ballroom virtually filled to capacity.

Reay Brown, MD, in private practice in Atlanta and a prolific inventor of glaucoma-related devices, said, “I never thought I’d see the day that there was a glaucoma day at ASCRS.”

Although cataract and refractive surgeons may not be well known for treating this disease, in fact a majority of them are involved in some aspect of glaucoma patient care. According to the American Academy of Ophthalmology (AAO; San Francisco) about 1,600 physicians, sometimes known as “glaucomatologists,” specialize in managing the disease.

Glaucoma is a global vision care problem, with nearly 7 million people blinded directly as a result and another 70 million affected by the disease. The World Health Organization (Geneva, Switzerland) recently stated that glaucoma is the second-leading cause of blindness in the world, exceeded only by cataracts.

In the U.S., the Eye Diseases Prevalence Research Group has noted that open-angle glaucoma (OAG, by far the most dominant form of glaucoma) affects more than 2 million individuals. Owing to the rapid aging of the U.S. population, this number is predicted to increase to more than 3 million by 2020.

Glaucoma is a collective term used to describe a heterogeneous group of slowly progressive disorders characterized by an elevation of intraocular pressure (IOP) within the eye, optic nerve dysfunction and visual loss. Irreversible deterioration of the optic nerve eventually causes loss of peripheral and ultimately central vision.

A landmark development in the management of glaucoma, which is a “silent” disease, occurred in 2000, when the first glaucoma detection benefit under Medicare was approved. Culminating several years of intensive lobbying by the AAO, this provision included an exam for individuals at highest risk of developing the disease, including African Americans and those with a family history.

Of all the diseases treated by ophthalmic medical professionals, glaucoma may be the most challenging one, for several reasons. For one, its exact origin and etiology are still controversial. Conventional wisdom is that glaucoma is precipitated by an elevated IOP and that this elevated pressure ultimately results in vision loss.

This traditional explanation of the disease drives the management of glaucoma, with a wide range of pharmaceuticals whose overriding goal is to reduce IOP are used. The worldwide market for glaucoma drugs is currently estimated at about $2 billion, in spite of the fact that many important agents are now off-patent and sell at a huge discount to patented compounds.

Contradicting this strategy to lower IOP is that only a portion of the estimated five million Americans who have an elevated IOP (so-called “ocular hypertensives”) develop optic nerve damage and subsequent impairment or loss of vision.

There has been a proliferation of new anti-glaucoma drugs in recent years, complicating the prescribing patterns for physicians. According to a presentation made over the weekend by Kuldev Singh, MD, associate professor of ophthalmology at Stanford University Medical Center (Menlo Park, California), “there have been more new glaucoma drugs released in the past 10 years than in the past 50 years.”

Another frustration is that patient compliance with anti-glaucoma medications is abysmally low. According to a study cited by Stephen Obstbaum, MD, professor of ophthalmology at the New York University School of Medicine (New York), more than half of all glaucoma patients do not take their prescribed medications or even keep their scheduled office visit after a positive screening test. He cited a variety of reasons, including side effects, inconvenient and complex regimen, the symptomless nature of the early to mid stages of the disease and the financial burden.

Quoting Joyce Cramer, MD, of Yale University (New Haven, Connecticut), who said that “drugs don’t work for patients who don’t take them,” Obstbaum urged the audience to adopt a multi-disciplinary approach to improve patient compliance and thereby enhance patient care.

In a session devoted to “Surgical Innovations/Horizons,” described by moderator Bradford Shingleton, MD, assistant clinical professor at Harvard Medical School (Boston) as “cutting edge and beyond,” several innovative surgical approached to the disease were discussed. This session included implants, laser therapy and new ultrasound imaging technology, which will be targeted to patients in whom medical management has failed or is inadequate to control their IOP.

This treatment patterns is in contrast to outside the U.S., where these technologies, supported by solid clinical trials that demonstrate efficacy and acceptable adverse events, play an important role in treating glaucoma patients. Most domestic patients are treated with medical management until there is a clear indication that more aggressive intervention is warranted.

In response to a question from Medical Device Daily on why more aggressive surgical techniques are not used until later in the course of this progressive disease, one physician (who preferred to remain anonymous) said that the huge marketing clout of the pharmaceutical industry affected treatment patterns in the U.S.

While there is no doubt that the audience benefited tremendously from the day-long presentations, the ongoing frustration of glaucoma disease management was tersely summed up by one of the luminaries in the field, Robert Weinreb, MD, a professor of ophthalmology at University of California, San Diego. Responding to a question on how to manage a challenging glaucoma patient, he sarcastically quipped, “we are trying to add clarity here when there really is none.”

This comment, perhaps better than any statement made all day, perfectly sums up the state of confusion of the glaucoma market in 2005.