QLT and CibaVision are adding another 200 sites with trained
Opthmalogists to treat AMD using Visudyne. This should
further support a rapid ramp of the drug once we get FDA
approval. Next month, maybe.
Ian.
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QLT Phototherapeutics Inc. (QLTI) 52 7/8 -2 1/8: Developer of pharmaceutical products for photodynamic therapy announces that its eye care unit, CIBA Vision, expands the clinical program for Visudyne therapy for the treatment of the wet form of age- related macular degeneration.
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Wednesday March 15, 1:03 pm Eastern Time
Company Press Release
SOURCE: CIBA Vision
Treatment-Investigational New Drug Program for Visudyne Therapy for
Wet AMD to Expand in North America
Expansion of Clinical Trial Offers Wider Access To Therapy Prior to Regulatory Approval
ATLANTA and VANCOUVER, British Columbia, March 15 /PRNewswire/ -- CIBA Vision, the eye care unit of Novartis AG, and QLT
PhotoTherapeutics, Inc. (Nasdaq: QLTI - news) announced today the expansion of the ongoing Treatment- Investigational New Drug (T-IND) clinical
program for Visudyne(TM) (verteporfin for injection) therapy for the treatment of the wet form of age- related macular degeneration (AMD). The program,
in which more than 3,000 patients in North America have already been treated, will be expanded to provide Visudyne therapy, prior to regulatory approval,
to additional patients with the predominantly classic form of wet AMD who meet specific eligibility criteria.
The program began September 15, 1999, with 200 participating sites each able to enroll up to 20 patients. An amendment to the T-IND filed March 15,
2000 with the FDA will allow for the addition of up to 200 new sites which will enroll up to 10 patients each. In addition, current sites will now be able to
treat up to 10 additional patients.
In a T-IND protocol, the US Food and Drug Administration (FDA) allows drug developers to provide pre-approval access to experimental drugs that are
intended to treat serious or life-threatening conditions for which there are no satisfactory treatments.
On February 11, 2000, the FDA issued an approvable letter for Visudyne therapy. An approvable letter, commonly issued prior to an approval, indicates
the agency intends to approve the application once additional material needed to complete the review is submitted and found acceptable. Once approved,
Visudyne therapy will be indicated for the treatment of AMD in patients with predominantly classic subfoveal choroidal neovascularization (CNV), the
indication sought by CIBA Vision and QLT.
``We are keenly aware of the urgent need many patients have for this potential sight-saving therapy now,' said Luzi von Bidder, President of CIBA Vision's
Worldwide Ophthalmics Business Unit. ``Expanding the current T-IND will allow more eligible patients to have access to Visudyne therapy prior to U.S.
approval.'
``We continue to work closely with the FDA as they complete their final review of Visudyne therapy,' said Julia Levy, President and CEO of QLT
PhotoTherapeutics. ``We are optimistic that we will soon have approval to provide this much-needed treatment for the many patients losing their vision to
this devastating condition.'
How to enroll
Before enrolling in the T-IND clinical program, the patient first must be evaluated by his/her personal eye care physician in order to determine if the patient's
condition meets specific eligibility criteria. Patients and/or practitioners may call the Visudyne Hotline, 1-800-821-2450 to obtain the specific enrollment
criteria for this clinical program. Following an eye exam, the patient and doctor can determine if the patient's ocular condition meets the enrollment criteria
for the clinical program. The eye doctor can then contact the Visudyne Hotline for the location of a participating center.
Inclusion/Exclusion Criteria
To be included in the program, patients must have the wet form of AMD with lesions secondary to AMD in which the lesions are predominantly classic
CNV. Additionally, patients must be 40 years or older and have corrected distance visual acuity in the same eye between 20/40 and 20/200 on a Snellen
or equivalent eye chart. A more detailed listing of the inclusion/exclusion criteria is available through the Visudyne Hotline, 1-800-821-2450.
Additional Background
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.
Expanded access programs are currently ongoing in more than 20 countries outside of North America.
Wet AMD is characterized by the formation of abnormal leaky blood vessels (choroidal neovasculature) that grow across the central part of the retina,
called the macula. The wet form represents an estimated 15% of all AMD cases but accounts for approximately 90% of the severe vision loss associated
with the disease. Currently available treatments are limited in effectiveness and only applicable for approximately 10% to 20% of the 500,000 new cases of
wet AMD that develop worldwide every year.
About Visudyne therapy
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. Shining
non-thermal laser light into the patient's eye then activates the drug.
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 - news), based in California, and the Carl Zeiss
Group, based in Germany.
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.
Background on CIBA Vision and QLT:
Visudyne therapy is being co-developed for various ocular conditions by CIBA Vision Corporation and QLT PhotoTherapeutics Inc. Upon
commercialization, CIBA Vision will market the product worldwide while QLT will be responsible for manufacturing.
Visudyne therapy is protected by a series of U.S. and foreign issued patents which cover the composition of matter, formulations and manufacturing, and
the method of use in treating AMD and other conditions.
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, ophthalmic surgical products, and ophthalmic pharmaceuticals. CIBA Vision
products are available in more than 70 countries. For more information, you are invited to visit the Company's website at www.cibavision.com .
CIBA Vision is the eye care unit of Novartis, a world leader in healthcare with core businesses in pharmaceuticals, consumer health, generics, eye care, and
animal health. In 1999, the Group (including Agribusiness) achieved sales of CHF 32.5 billion and invested more than CHF 4.2 billion in R&D.
Headquartered in Basel, Switzerland, Novartis employs about 82,400 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 potential breakthrough treatments in ophthalmology and autoimmune disease.
In addition to Visudyne therapy, QLT's portfolio of products include PHOTOFRIN© (porfimer sodium), the world's first approved photodynamic therapy
drug, used in the treatment of various cancers throughout North America, Japan and Europe.
Visudyne(TM) is a trademark of Novartis AG.
PHOTOFRIN© is a registered trademark of QLT PhotoTherapeutics Inc.
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? 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 |
