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The future of AMD therapies in Europe, Canada

MarketScope

Several new drugs and treatments are showing some promise in the fight against age-related macular degeneration (AMD), a condition that has had disappointingly few effective treatments. Here are the latest developments for three of them.

Visudyne may be too popular in Europe

P hotodynamic therapy in conjunction with the drug Visudyne was approved for certain forms of wet AMD in the United States, Canada and the European Union in 2000 . The drug is marketed by Novartis, based in Basel , Switzerland . The European Medicines Agency, the EU reviewer, was less than enthusiastic. “Although the total numerical benefits obtained may seem moderate, the results should be considered in the perspective of the poor prognosis for the population,” it said.

Approval in the U.K. for coverage by the National Health Service just came last September, only after a letter-writing campaign. Conservative Leader Michael Howard accused Prime Minister Tony Blair of foot-dragging on the floor of the House of Commons. The NHS now covers PDT with Visudine for classic lesions, and patients with predominantly classic lesions are getting it through a national research study, the Visudyne PDT Cohort Study, according to Tom Bremridge, CEO of the Macular Disease Society.

In Germany , Rainald von Gizycki, honorary president of Pro Retina Germany , a disease group, says demand for the treatment was so high that authorities had to raise the spending ceiling for it. Gizycki reports it is being used “too widely,” beyond the classic population it was intended for. He says it actually leads to a worsening of sight in 5 percent to 10 percent of patients.

Macugen still not approved abroad

This is the first in a new class of ophthalmic drugs known as VEGF inhibitors, used for wet AMD. Eyetech Pharmaceuticals and Pfizer are co-marketing it in the United States, while Pfizer alone will market it abroad. Macugen was launched in the U.S. in December 2004, but its progress has been slower abroad. Applications were filed in September 2004 both in Canada and with the EU. Trials are ongoing in Europe . In Germany , Gizycki says Pfizer is expected to announce the next stage of trials for Macugen.

In the U.K. , a few eye hospitals are participating in the trials and the National Institute for Clinical Excellence, which approves coverage by the National Health Service, is expected to make a decision by the end of the year, according to Bremridge at the Macular Disease Society. “Macugen is well regarded as the next step,” he says. “However, there are still some serious logisitic issues to sort out. The treatment involves injections into the eye every six weeks for about 18 months. Bringing elderly people back to clinics with this frequency will pose its own problems and costs. ”

For Rheopheresis, the jury is still out

In the U.S. , this treatment for dry AMD is in the middle of an FDA-approved trial called MIRA-1. The therapy, similar to dialysis, fills a big gap. There is no widely accepted treatment for dry AMD, the less advanced stage that affects 85 percent of patients. It is thought to remove materials in the blood that block passage in the tiny veins in the eyeball.

“We have a great future with this procedure,” says Bernard Erdtracht, MD, director of the Rheopheresis Center in Cologne , the city where the treatment was developed. Dieter Klaas , MD , an ophthalmologist in Friedberg , Germany , says Rheopheresis is “the first therapy that has reached a positive impact on the natural course of this condition with a large number of patients and without destroying tissue.” The German nephrologists society has issued a statement in favor of Rheopherese, but the ophthalmologists group has not done so.

The Cologne center claims that AMD's progress can be stopped in more than two-thirds of treatments and often vision is improved. In the first Rheopheresis trial, MAC-1, carried out in Germany , the control group showed a mean deterioration of 0.94 lines, while the treatment group showed an improvement of 0.63 lines, a mean difference of 1.57 lines immediately post-treatment.

Dr. Erdtracht says the therapy was approved in Germany in 1998 and is now used “all over Europe .” But Frank G. Holz, chairman of the department of ophthalmology at the University of Bonn , says it is only available at small small clinics, and even they remain unsure of its effectiveness. “I do not regard Rheopheresis as a clinical option,” says Dr. Holz, adding that the interim MIRA-1 data. “are not significant and the design of the trial does not make sense.” Dr. Erdtracht says Dr. Holz is working on the competing Macugen trial, but Gizycki at Pro Retina Germany also reports that the treatment is “not generally well known in Germany .”

Gizycki says the Consolidated Federal Committee, which approves treatments for coverage by the government-sponsored health funds for 85 percent of Germans, has not made a conclusion about Rheopheresis. But he also notes that the nation's largest private insurer, Deutsche Kranken-Versicherung, has agreed to reimburse part of the costs.

In Canada , home of OccuLogix, which holds the North American rights to Rheopheresis, Toronto-based RHEOVision opened its first treatment center on Jan. 1 and plans to expand in March to Windsor , where it will try to solicit U.S. business across the border, a company spokesman says. The company plans to open four other sites by summer. Although the treatment is approved in Canada , no insurer there covers it yet, the spokesman added.

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