Novartis: EU Commission approves extended use of Visudyne™

26-Mar-2001

Novartis Ophthalmics, the eye health unit of Novartis AG, and QLT Inc. announced today that the European Commission has granted Marketing Authorization for Visudyne™ for the treatment of subfoveal choroidal neovascularisation (CNV) secondary to pathologic myopia (severe near-sightedness), a serious eye disorder that can result in a progressive loss of vision. Visudyne is already approved for the treatment of predominantly classic subfoveal (CNV) caused by age-related macular degeneration (AMD). Pathologic myopia CNV generally occurs among people over 30 years of age. Visudyne is the first approved drug treatment for this devastating condition.

"With approval for the extended indication of pathologic myopia throughout the European Union, Visudyne provides new hope for patients who have a progressive loss of vision due to CNV secondary to pathologic myopia," said Luzi von Bidder, Head of Novartis Ophthalmics. "We are pleased that the EU Commission responded so quickly with its ruling."

Dr. Julia Levy, President and CEO of QLT Inc. said: "This European marketing authorization clearly marks the first of several significant milestones in the extension of Visudyne anticipated for the year. The aggressive extension program, on the heels of the most successful first-year sales of an ophthalmic product, confirms the success of our partnership with Novartis Ophthalmics."

On 5 February 2001, the US FDA also issued an approvable letter for the extended use of Visudyne and is actively reviewing additional information provided by Novartis Ophthalmics and QLT.

CNV due to pathologic myopia

Pathologic myopia is the leading cause of CNV in adults aged 50 and under. CNV secondary to pathologic myopia is caused by abnormal blood vessels that grow under the center of the retina as a result of an abnormal elongation of the eyeball. It generally occurs among people over 30 years of age and can result in a progressive loss of vision. The worldwide incidence of CNV due to pathologic myopia is estimated to be 50 000 new cases per year.

For further details including prescribing information, visit http://www.visudyne.com.

The foregoing press release contains forward-looking statements that involve known and unknown risks, uncertainties and other factors which may cause the actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. Such factors include, but are not limited to: risks associated with the commercialization of Visudyne™ including patient and physician demand for the treatment; dependence on corporate relationships; manufacturing uncertainties; uncertainty of pricing and reimbursement; uncertainties relating to clinical trials and completion of analysis of the trials discussed in this release and product development; outcome of litigation claims; QLT Inc.'s history of operating losses and uncertainty of future profitability; competition; QLT Inc.'s rapid growth; uncertainty regarding patents and proprietary rights; product liability claims and insurance; no assurance of regulatory approval; government regulation; QLT Inc.'s uncertainty of access to capital; anti-takeover provisions; and volatility of common share price; among others, all as described in QLT Inc.'s Annual Information Form on Form 10-K and recent and forthcoming quarterly reports on Form 10-Q, Novartis AG's Form 20-F on file, and other filings with the U.S. Securities and Exchange Commission.

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 count

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