ASIANET: FDA Takes Positive Action as Visudyne Review Nears Completion

ATLANTA and VANCOUVER, British Columbia, Feb. 11 /PRNewswire-AsiaNet/ -- CIBA Vision, the eye care unit of Novartis, and QLT PhotoTherapeutics Inc. (Nasdaq: QLTI) announced today that the U.S. Food and Drug Administration (FDA) has issued an approvable letter for Visudyne(TM) (verteporfin for injection) therapy to treat the wet form of age-related macular degeneration (AMD), the leading cause of blindness in people over the age of 50 in the western world. An approvable letter, commonly issued prior to an approval, indicates the agency intends to approve the application.

In the letter received by QLT and CIBA Vision today the FDA stated that they have reviewed the application and Visudyne therapy is approvable. The FDA recognises that any remaining deficiencies identified in the letter may have been addressed by recent information provided to the FDA by QLT, but that material is still under review.

Once the review is completed and the information has been found satisfactory, the FDA has indicated they will approve Visudyne therapy  specifically for the treatment of AMD in patients with predominantly classic  subfoveal choroidal neovascularization (CNV), the indication sought by CIBA  Vision and QLT.

"We are pleased that there are no major outstanding issues raised in the FDA's letter or issues requiring additional clinical trials," said Dr. Julia  Levy, President and CEO of QLT.  "As always we intend to work closely with the  agency as it completes its review."  Dr. Levy added that QLT doesn't expect  any major delays prior to approval.

The FDA recognizes that the wet form of AMD is a serious condition that robs patients of their central vision and one for which existing treatments  are limited.  As such, on August 23, 1999, the Visudyne submission was granted  priority status, which required the agency to respond to the application on or  before February 12, 2000.

"This is a significant milestone," said Luzi von Bidder, President of CIBA Vision's worldwide Ophthalmics Business Unit.  "This letter indicates that Visudyne therapy will soon provide a much-needed treatment for the many patients losing their vision to this devastating condition."

Von Bidder added that, in the interim, CIBA Vision will continue to provide treatment to eligible patients through its ongoing Treatment- Investigational New Drug (T-IND) program, in which more than 2600 patients in North America have been treated to date.

Visudyne therapy received regulatory approval in Switzerland on December 16, 1999.  Regulatory applications are pending in the European Union, Canada, Norway, Iceland, Australia, and New Zealand.

Some medical experts estimate that of the 500,000 new patients afflicted with wet AMD every year around the world, 40-60% will develop predominantly classic lesions during the progression of their disease.

About AMD and Visudyne therapy

Wet AMD typically destroys central vision, which is necessary for reading, driving, and recognizing faces.  The condition is characterized by the formation of abnormal blood vessels (choroidal neovascularization or CNV) that grow across the central part of the retina, called the macula.  These vessels leak fluid and eventually cause scar tissue, which destroys central vision in as little as two months to three years.  Visudyne therapy is a two-step procedure that can be performed in a doctor's office.  First, Visudyne is injected intravenously into the patient's arm.  The drug is then activated by shining non-thermal laser light into the patient's eye.

Visudyne therapy involves the use of a specifically designed laser that produces the low level, non-thermal 689 nm light required to activate the drug. These lasers have been developed by two of the world's leading laser companies, Coherent Inc. (Nasdaq: COHR), based in California, and the Carl Zeiss Group, based in Germany, and comprise the two device PMAs submitted in conjunction with the NDA.

Additional clinical trials are being conducted to determine the effectiveness of Visudyne therapy in patients with an earlier stage of AMD originally excluded from the TAP Investigation as well as patients with a similar but distinct condition of abnormal blood vessels associated with progressive near-sightedness known as pathologic myopia.  Results are expected in the second quarter of 2000.

Visudyne is being co-developed for ocular conditions by CIBA Vision Corporation, the eye care unit of Novartis AG, and QLT PhotoTherapeutics Inc. Upon commercialization, CIBA Vision will market the product worldwide while QLT will be responsible for manufacturing the product.

Visudyne therapy is protected by a series of U.S. and foreign-issued patents that cover the composition of matter, formulations and manufacturing, and the method of use in treating AMD and other conditions.

Background on CIBA Vision and QLT

With worldwide headquarters in Atlanta, Georgia, USA, CIBA Vision is a global leader in research, development and manufacturing of optical and ophthalmic products and services, including contact lenses, lens care products and ophthalmic pharmaceuticals.  CIBA Vision products are available in more than 70 countries. For more information, you are invited to visit the CIBA Vision web site at www.cibavision.com .

CIBA Vision is the eye care unit of Novartis AG, a world leader in healthcare with core businesses in pharmaceuticals, consumer health, generics, eye-care, andanimal health.  In 1998, the Group (including Agribusiness) achieved sales of CHF 31.7 billion and invested more than CHF 3.7 billion in R&D. Headquartered in Basel, Switzerland, Novartis employs about 82,000 people and operates in over 140 countries around the world.  The Group recently announced plans to spin off its Crop Protection and Seeds sectors and to merge them with the agrochemicals business of AstraZeneca in the second half of 2000.

QLT PhotoTherapeutics Inc. is a world leader in the development and commercialization of proprietary pharmaceutical products for use in photodynamic therapy, an emerging field of medicine utilizing light-activated drugs in the treatment of disease.  QLT's innovative science has advanced photodynamic therapy beyond applications in cancer towards breakthrough treatments in ophthalmology and autoimmune disease.

In addition to Visudyne therapy, QLT's portfolio of products include PHOTOFRIN(R) (porfimer sodium), the world's first approved photodynamic therapy drug, used in the treatment of various cancers throughout North America, Japan and Europe. For more information, you are invited to visit QLT's web site at www.qltinc.com .

Visudyne(TM) is a trademark of Novartis AG

PHOTOFRIN(R) is a registered trademark of QLT PhotoTherapeutics Inc.

EDITORS' ADVISORY:  The treatment of wet AMD with Visudyne therapy is currently investigational.  Only patients who are currently enrolled in clinical trials sponsored by QLT and CIBA Vision, patients recruited under the Treatment-IND in the U.S. or under expanded access programs meeting local requirements in certain other countries, are eligible for treatment at this time. Patients and practitioners seeking additional information may view our web site at www.visudyne.com or call 1-800-821-2450.

CIBA Vision contacts:

Ann Berry

CIBA Vision Corporate Communications

11460 Johns Creek Parkway

Duluth, Georgia USA 30097

Telephone: (678) 415-3646, Fax: (678) 415-3592

QLT PhotoTherapeutics Inc. contacts:

Elayne Wandler or Tamara Hicks

QLT Corporate Communications and Investor Relations

520 West 6th Avenue

Vancouver, BC Canada V5Z 4H5

Telephone: 1-800-663-5486, (604) 872-7881

Fax: (604) 873-0816

For more information, you are invited to visit the QLT web site at www.qltinc.com

QLT PhotoTherapeutics Inc. is listed on The Nasdaq Stock Market under the  trading symbol "QLTI" and on The Toronto Stock Exchange under the trading symbol "QLT."

The foregoing information contains forward-looking statements which 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: risks associated with the commercialization of Visudyne(TM) therapy; dependence on corporate relationships; manufacturing uncertainties; uncertainty of pricing and reimbursement; uncertainties relating to clinical trials and product development; the Company's history of operating losses and uncertainty of future profitability; competition; rapid growth; uncertainty regarding patents and proprietary rights; product liability claims and insurance; no assurance of regulatory approval; government regulation; uncertainty of access to capital; anti-takeover provisions; and volatility of common share price; among others, all as described in the Company's Annual Information Form on Form 10-K.

SOURCE  CIBA Vision

CONTACT:  Ann Berry of CIBA Vision Corporate Communications, 678-415-3646 or

Web site:  http://www.visudyne.com

Web site:  http://www.qltinc.com

Web site:  http://www.cibavision.com