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FDA APPROVES VISUDYNE FOR MYOPIA/OCULAR HISTOPLASMOSIS.

Novartis Ophthalmics, the eye health unit of Novartis AG, and QLT Inc. (Nasdaq: QLTI; Toronto) has announced that the FDA has approved Visudyne(TM) (verteporfin for injection) therapy for the treatment of predominantly classic subfoveal choroidal neovascularization (CNV) due to pathologic myopia (severe near-sightedness) and presumed ocular histoplasmosis. Visudyne is the only drug treatment approved for these devastating eye conditions.

"The FDA approval is great news," said Dr. Julia Levy, president and CEO of QLT. "For the first time, patients who would otherwise face a progressive loss of vision now have an effective treatment option. The approval also represents another advance in our efforts to combat serious ocular conditions with Visudyne."

Dan Myers, president of Novartis Ophthalmics, North America said, "The fact that Visudyne therapy has demonstrated the ability to stabilize and in some cases improve vision in these pathologic myopia and presumed ocular histoplasmosis patients is another remarkable success story for this breakthrough therapy. We're very pleased to now be able to make Visudyne available to the tens of thousands of patients who develop these conditions."

In phase III studies in patients with CNV due to pathologic myopia, Visudyne therapy stabilized or improved vision (as defined by a loss of less than 8 letters on a standard eye chart) in 72% of patients versus 44% on placebo at month 12.

In an open label safety study involving 26 patients with ocular histoplasmosis, visual acuity improved by an average of more than 1 line on a standard eye chart at 12 months (6.7 letters on a standard eye chart) with 28% of patients experiencing a visual acuity improvement of 3 lines (15 letters) or more. Visual acuity decreased by less than 3 lines of vision in 88% of patients during the same time period.

Visudyne was approved in April 2000 in the United States and has since been launched in almost 50 countries for the treatment of predominantly classic CNV caused by age-related macular degeneration (AMD), the leading cause of blindness in people over the age of 50.

CNV due to Pathologic Myopia

CNV in pathologic myopia is characterized by abnormal blood vessels that grow under the center of the retina as a result of an abnormal elongation of the eye associated with severe near-sightedness or myopia. It generally occurs among people over 30 years of age and can result in a progressive, severe loss of vision. The worldwide incidence of CNV due to pathologic myopia is estimated to be 50,000 new cases per year.

Presumed Ocular Histoplasmosis

In presumed ocular histoplasmosis, CNV develops from the margin of retinal scars in the back of the eye, which are caused by a fungal infection of the retina. It can lead to severe, irreversible vision loss. The condition is caused by inhaling the fungus Histoplasma capsulatum which is found predominantly in the mid-central U.S. The fungus generally remains in a dormant stage but tends to become more active when a person's immune system is compromised.

About Visudyne

Visudyne therapy is a two-step procedure that can be performed in a doctor's office. First, the drug is injected intravenously into the patient's arm . A non-thermal laser light is then shone into the patient's eye to activate the drug. Visudyne therapy uses a specially-designed laser that produces the low level, non-thermal 689nm light required to activate the drug. Visudyne is generally well tolerated and has an excellent safety profile. Potential side effects include injection site reactions, headaches, blurring, decreased sharpness and gaps in vision, and in 1-4% of patients a substantial decrease in vision with partial recovery in many patients. People should avoid direct sunlight for five days to avoid sunburn. People with porphyria should not be treated.

For more information, visit http://www.visudyne.com.

Background on Novartis Ophthalmics and QLT

With worldwide headquarters in Bulach, Switzerland, Novartis Ophthalmics is a global leader in research, development and manufacturing of leading ophthalmic pharmaceuticals that assist in the treatment of glaucoma, age related macular degeneration, eye inflammation, ocular allergies and other diseases and disorders of the eye. Novartis Ophthalmics products are available in more than 110 different countries. The North American headquarters is based in Atlanta, Georgia. Novartis Ophthalmics has production sites in Switzerland, France and Canada. For more information, visit http://www.novartisophthalmics.com/ or http://www.novartisophthalmics.com/us.

Novartis is a world leader in healthcare with core businesses in pharmaceuticals, consumer health, generics, eye-care, and animal health. In 2000, the Group's ongoing businesses achieved sales of CHF 29.1 billion (USD 17.2 billion) and a net income of CHF 6.5 billion (USD 3.9 billion). The Group invested approximately CHF 4.0 billion (USD 2.4 billion) in R&D. Headquartered in Basel, Switzerland, Novartis employs about 70,000 people and operates in over 140 countries around the world. For further information, visit http://www.novartis.com.

QLT Inc. is a world leader in photodynamic therapy, a field of medicine utilizing light-activated drugs in the treatment of disease. QLT's innovative

science hasled to the development and commercialization of breakthrough treatments utilizing this technology for applications in ophthalmology and oncology and is exploring the potential in other diseases.

For more information, call 770-905-1020 or 604-707-7000 or visit http://www.visudyne.com or http://www.novartisopthalmics.com.
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Publication:Biotech Business
Date:Oct 1, 2001
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