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$2 per dose vs. $1500 per dose: One doctor develops new therapy for macular degeneration

New combination therapy works to treat the largest cause of blindness in people over 50

Jeffries Marketing, LTD

New York, NY- Richard Spaide, MD, ophthalmologist at the Vitreous, Retina, Macula Consultants of New York (www.vrmny.com), has developed a new combination treatment for "wet" age-related macular degeneration, the largest cause of blindness in people over the age of 50 years. Dr. Spaide presented this new treatment, the first treatment where a group of patients with age-related macular degeneration actually improved in acuity with treatment, this week on October 22, 2002 at the Annual Meeting of the American Academy of Ophthalmology in Orlando, Florida. "Wet" age-related macular degeneration is caused by the inappropriate growth of blood vessels under the macula. These blood vessels may leak, bleed, and cause scar tissue to form. It is the largest cause of blindness in people over the age of 50 years.

Dr. Spaide's treatment involves giving the photodynamic therapy and an injection of triamcinolone, a drug normally used for the treatment of inflammatory conditions such as arthritis, into the eye. Visudyne infusion is given to a patient followed by a treatment with a cold laser that does not injure the macular tissue.The combination of the drug and the cold laser results in an activated version of the drug causing the newly growing vessels to shut down and temporarily slows the growth of the macular degeneration. The problem with this treatment is the effects are only temporary. The vessels eventually re-grow with the result that most patients need between 3 and 4 treatments during the first year. Even with treatment most patients lose vision. The cost for the treatment is very high and many doubt its cost-effectiveness. Clinical trials have found that photodynamic therapy only works on a subset of patients with the wet form of age-related macular degeneration. Most patients cannot be treated with photodynamic therapy alone. Triamcinolone reduces the growth of vessels and decreases inflammation. The combination of photodynamic therapy with Visudyne followed by intravitreal triamcinolone appearred to be an effective treatement for the wet type of macular degeneration. Patients treated with the combination therapy had, on the average, a 1.9 line improvement in visual acuity by 3 months as compared with their baseline visual acuity. Patients treated with the combination therapy needed less retreatments during follow-up. This is important because Visudyne costs $1,500 per dose, while triamcinolone costs a few dollars per dose. In a series of 26 patients treated with the combination therapy 8% needed retreatment at 3 months whereas approximately 90% of patients in a trial of photodynamic therapy with Visudyne alone needed retreatment at 3 months. In the initial study all forms of wet macular degeneration appeared to respond, not just a minority.

Dr. Spaide's development is noted because:

  • improvement in acuity among treated patients. This is unusual for age-related macular degeneration, a chronic degenerative disease.
  • the use of a medication, triamcinolone, in an initially unexpected way, dramatically improved the performance of treated patients. Note that Visudyne costs $1500 per dose and trimacinolone, a few dollars per dose. Triamcinolone is not usually given in the eye. It is frequently given in knees and other joints for arthritis.
  • the treatment was developed by a single doctor, not a corporation.
  • the treatment seems to work in all forms of wet macular degeneration.

Other approaches to subfoveal choroidal neovascularization in age-related macular degeneration include:

    1. Photodynamic therapy with Visudyne. The efficacy of this treatment has been proven by randomized trial. This type of therapy is applicable to only a small minority of patients with subfoveal choroidal neovascularization. The use of Visudyne is approved in the US for those patients with "classic" choroidal neovascularization . Most patients do not have classic choroidal neovascularization. Treated patients continue to lose visual acuity, but not as fast as untreated patients.

    2. Anecortave acetate. Recently the 12-month data from a pilot study examining injections of anecortave acetate at 6 month intervals showed that a 15mg dose, but not a 3 or 30 mg dose was associated with decreased loss of visual acuity in treated patients as opposed to controls. Treated patients still lost acuity, just less than untreated controls. Of treated patients 18% had an improvement of acuity of at least 2 lines at 6 months, a lower threshold used in many studies. This medication has been tested in patients with predominantly classic choroidal neovascularization. (http://www.pslgroup.com/dg/21540a.htm )

    3. Eyetech 001. This drug has been examined in a small pilot series. This medication is given as repeated injections into the eye. Of patients treated 27% had an improvement of 3 or more lines acuity after 3 months.

    4. ruFab. This is an antibody fragment made by Genentech. This medication requires monthly injections into the eye. Intraocular inflammation is a common side-effect of this medication. Of treated patients 26% had improvement by 3 lines of acuity. (http://www.macular.org/news/clinical/rhufab.html)

    5. Triamcinolone and Photodynamic therapy with Visudyne. Patients are treated with photodynamic therapy and a single intravitreal dose of trimacinolone, a generic corticosteroid. At the three-month follow-up among patients newly treated with this method, 30.8% had an improvement of 3 or more lines. The patients as a group had an improvement in visual acuity at 3 months as compared with baseline.

Triamcinolone is a low cost, generic, corticosteroid that has a number of effects, including reduction of both vessel growth and inflammation. In Dr. Spaide's development, the addition of trimacinolone to the expensive Visudyne treatment resulted in visual acuity gain with less treatments in the short term. The results of this new treatment appear similar to other investigational medications aimed at inhibiting the growth of vessels in the eye. The major difference is the other drugs need to be given as monthly injections.

Dr. Spaide specializes in diseases of the retina and vitreous. Dr. Spaide has published numerous articles and book chapters about the diagnosis and treatment of retinal diseases. His research interests include macular degeneration, biochemical analysis of lipids in Bruch's membrane, ocular imaging, and intraocular inflammation.

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