Thursday May 10, 7:07 pm Eastern Time
Press Release
SOURCE: QLT Inc.
Favorable Visudyne(TM) clinical results published in American Journal of Ophthalmology show benefit in AMD patients with occult disease
Regulatory Strategy Updated Based on These Results
ATLANTA, GA and VANCOUVER, BC, May 10 /PRNewswire/ - Novartis Ophthalmics, the eye health unit of Novartis AG (NYSE:NVS - news), and QLT Inc. (NASDAQ:QLTI - news; TSE:QLT - news) today announced that the American Journal of Ophthalmology, a leading peer-reviewed medical journal, has published favorable two-year results from a phase III clinical trial, showing Visudyne(TM) (verteporfin for injection) therapy has a significant treatment benefit in age-related macular degeneration (AMD) patients presenting with occult without classic choroidal neovascularization (CNV). This is the first time a benefit has been shown in these patients in a large-scale randomized clinical trial.
AMD is the leading cause of blindness in people over the age of 50. The wet form of the disease results from abnormal blood vessels (choroidal neovascularization or CNV) under the central part of the retina. ``Occult'' and ``classic'' are terms used to describe the different patterns of CNV leakage as seen on fluorescein angiography.
``Based on these results, ocular photodynamic therapy with Visudyne should be considered as a treatment for AMD patients with lesions composed of occult without classic CNV with presumed recent disease progression,'' said Dr. Neil Bressler, Chair of the Visudyne Study Advisory Group and retinal specialist and Professor of Ophthalmology at the Wilmer Eye Institute of the Johns Hopkins University School of Medicine in Baltimore, Maryland. ``The results clearly show that for these patients, Visudyne therapy reduces the risk of moderate and severe vision loss, particularly in cases presenting with either smaller lesions or lower levels of visual acuity.''
Dr. Julia Levy, President and Chief Executive Officer of QLT added, ``These findings are significant as this patient group currently has no treatment options. To this end, we will aggressively pursue approvals based on these positive results by completing filings in Europe and Canada within the next few months. In the U.S., following discussions with the Food and Drug Administration (FDA), it was determined that in accordance with standard practice, a second trial is necessary for replication. We intend to initiate this study in the third quarter once a protocol has been agreed upon with the FDA.''
``This publication, on the heels of the release of favorable three-year data in predominantly classic AMD patients, will broaden the use of Visudyne,'' said Luzi von Bidder, Head of Novartis Ophthalmics. ``Visudyne has already gained wide acceptance around the world as an effective treatment for AMD and through the continued publication of strong clinical results such as these, its importance will continue to grow.''
VIP (Verteporfin in Photodynamic therapy) Study Details:
The following two-year results are based on 258 AMD patients (76% of the
entire study population) with occult CNV without a classic component.
- 55% of the Visudyne-treated group compared with 68% of the placebo-
treated group lost at least 15 letters or 3 lines of vision on a
standard eye chart (p equals 0.032) while 29% of the Visudyne-treated
group and 47% of the placebo-treated group lost at least 30 letters or
6 lines of vision (p equals 0.004).
- All secondary outcomes, including visual acuity letter score less than
34 (20/200 or worse), mean change in visual acuity letter score,
development of classic CNV, progression of classic CNV, and size of
lesion, favored Visudyne-treated patients.
Further prospectively defined analysis showed that the treatment benefit was greater for patients with either smaller lesions or lower levels of visual acuity at baseline.
Of the 123 Visudyne-treated patients and 64 placebo-treated patients with either visual acuity score less than 65 letters or lesion size less than or equal to 4 disc areas at baseline, 49% and 75% lost at least 15 letters (p less than 0.001), respectively and 21% and 48% lost at least 30 letters (p less than 0.001), respectively at the month 24 examination.
The trial also reconfirmed Visudyne's favorable safety profile as no new
safety concerns were identified during the second year of treatment.
- As reported earlier, during the first year of treatment 4% of patients
experienced an often transient, severe vision decrease within 7 days of
the initial treatment.
- The most frequently reported adverse events attributed to the treatment
were injection site events and visual disturbances. Photosensitivity
reactions occurred in less than 1% of patients.
Patients treated with Visudyne received an average of five treatments during the 24-month period.
Background Information:
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. 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 a favorable 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. Patients must follow an appropriate light-protection period as specified in the package insert. People with porphyria should not be treated.
Visudyne is currently approved for the treatment of patients with predominantly classic subfoveal CNV caused by AMD in over 35 countries and for the treatment of CNV due to pathologic myopia in Europe. Regulatory approval is pending in the U.S. for an expanded label which would potentially include predominantly classic lesions caused by AMD as well as other macular diseases.
For more information, including full prescribing information, visit www.visudyne.com.
The foregoing press release contains forward-looking statements that can be identified by terminology such as ``intends,'' ``expected,'' ``potential,'' or similar expressions. Such forward-looking statements 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(TM) 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 countries. The North American headquarters is based in Atlanta, Georgia.
Novartis Ophthalmics has production sites in Switzerland, France and Canada. For more information please go to the website www.novartisophthalmics.com.
Novartis (NYSE: NVS - news) 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 invested approximately CHF 4.0 billion (USD 2.4 billion) in R&D. Headquartered in Basel, Switzerland, Novartis employs about 67,600 people and operates in over 140 countries around the world. For further information please consult 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 has led to the development and commercialization of breakthrough treatments utilizing this technology for applications in ophthalmology and oncology and is exploring the potential in immune disorders. For more information, you are invited to visit QLT's web site at www.qltinc.com.
Visudyne(TM) is a trademark of Novartis AG
SOURCE: QLT Inc. |
