QLT and Ciba Vision seek to expand the indication for
Visudyne
Supplemental new drug application submitted to FDA for eye conditions beyond age-related macular degeneration
ATLANTA, and VANCOUVER, Aug. 14 /CNW-PRN/ - CIBA Vision Corporation, the eye care unit of Novartis AG
(NYSE:NVS - news), and QLT Inc. (NASDAQ:QLTI - news; TSE:QLT - news) today announced the filing of a supplemental new drug application (sNDA) for Visudyne(TM) (verteporfin for injection) therapy with the United States Food and Drug
Administration (FDA) for the treatment of eye diseases beyond age-related macular degeneration (AMD), the leading cause of blindness among people over the age of 50.
Visudyne has already been approved for commercial use in AMD patients with predominantly classic choroidal
neovascularization (CNV) in 22 countries, including the U.S., Canada, European Union, and Australia. CNV is a growth of abnormal blood vessels under the central part of the retina, or macula. These vessels leak fluid and cause scar tissue that destroys central vision, resulting in a deterioration of sight.
QLT and CIBA Vision seek to expand the initial indication to include patients with other ocular conditions characterized by CNV. These other diseases include pathologic myopia (PM), ocular histoplasmosis syndrome (OHS), angioid streaks, CNV
due to certain retinal abnormalities, and idiopathic causes, among others.
The specific expanded label requested is for the treatment of patients with predominantly classic subfoveal choroidal
neovascularization (CNV) caused by AMD, or with subfoveal CNV secondary to other macular diseases.
This supplemental filing is based primarily on new safety and efficacy findings that were presented at the Association for Research in Vision and Ophthalmology meeting in May 2000 and recently submitted for publication in a leading peer-reviewed ophthalmology journal.
The companies have requested a priority review from the FDA within a six-month period as there is no current satisfactory treatment for the majority of patients with these conditions. A similar request for expanded labeling will be made in the European Union by the end of 2000.
``As global acceptance of Visudyne continues to grow with new countries granting marketing clearance, it is exciting to expand the use of this therapy to provide hope for patients faced with the threat of losing their sight due to other ocular diseases,'' said Luzi von Bidder, President of CIBA Vision's worldwide Ophthalmics Business Unit.
``In our fight against blindness,'' said Dr. Julia Levy, President and Chief Executive Officer of QLT, ``the prospect of saving the vision of patients developing these other conditions, often in the prime of their careers and the midst of raising their families, is significant particularly when existing treatment options are limited or non-existent.''
CNV due to Pathologic Myopia (PM)
CNV due 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 back 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 loss of vision for which there is no approved treatment for the majority of patients. The worldwide incidence of CNV due to pathologic myopia is estimated to be 50,000 new cases per year, excluding Asia where the incidence may be even greater due to a higher prevalence of pathologic myopia.
The results for patients with CNV due to pathologic myopia are based on a single study involving 120 patients with the
condition who were enrolled in a Phase IIIb 24-month multi center randomized placebo-controlled study called the VIP
(Verteporfin In Photodynamic therapy) Trial. At 12 months, patients showed a significant benefit from Visudyne therapy with respect to visual acuity, contrast sensitivity, lesion size, amount of leakage and other outcomes.
Specifically, 86.4% of patients receiving Visudyne therapy lost less than 3 lines of vision, or 15 letters, on a standard eye chart, compared to 66.7% of patients administered a placebo (p=0.01). More patients treated with Visudyne therapy (64%) compared to placebo (42%) had stable (plus or minus 4 letters on a standard eye chart) or improved visual acuity (greater than a 4 letter gain) at 12 months. Furthermore, Visudyne-treated patients (32%) were twice as likely as those patients on placebo (15%) to show an improvement of at least 5 letters of vision at the 12 month time point. At all follow-up visits starting at three months after the initial treatment, the mean visual acuity loss in the Visudyne group was one-third or less than that in the placebo group.
Patients in the study assigned to Visudyne received an average of 3.4 treatments during the 12-month period and are continuing to be followed for an additional 12 months.
Ocular histoplasmosis syndrome (OHS)
OHS is a condition caused by a fungal infection of the retinal area endemic to certain areas in the central and eastern United States. It can lead to severe, irreversible vision loss and is a leading cause of blindness in adults who have lived in the geographic areas where the soil mold Histoplasma capsulatum is found. The condition is caused by inhaling the fungus from soil or other areas that have been contaminated by the droppings of birds or bats. Annually, there are an estimated 100,000 people who are at risk for vision loss within this endemic area.
In an open-label safety study involving 26 patients with OHS, mean visual acuity scores increased from baseline by 6.8 letters at nine months after the initial treatment. Visual acuity scores improved by 5 or more letters from baseline in 54% of patients at the same time point, with 33% of patients gaining 15 or more letters of visual acuity at nine months. Mean contrast sensitivity scores also increased from baseline by 2.7 letters at nine months and contrast sensitivity scores improved 3 or more letters from
baseline in 42% of patients at the same time point.
Safety of Visudyne therapy
Visudyne has a favorable safety profile in all patients treated with CNV. The most frequently reported adverse events found in clinical studies and attributed to the treatment include injection site events and visual disturbances. Based on additional commercial and clinical trial use, no new safety issues have been identified that suggest a change in the benefit-risk ratio, thereby
demonstrating that Visudyne is safe, independent of the patient population studied.
Rationale for filing
Visudyne therapy has been shown to be safe and efficacious in predominantly classic subfoveal CNV secondary to AMD and
subfoveal CNV in PM. Additionally, the initial effect on visual function in ocular histoplasmosis appears consistent with findings in pathologic myopia. Based on these findings, the supplemental NDA seeks approval of Visudyne therapy for PM, OHS and a variety of other diseases characterized by CNV, in particular those in which the lesions are typically predominantly classic, even though the etiology of the formation of CNV is different for each disease, such as multifocal choroiditis, angioid streaks, certain retinal abnormalities, idiopathic or unknown causes, and many other rare conditions. Together these conditions, along with
AMD, PM and OHS, comprise virtually 100% of all subfoveal CNV cases.
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, then a non-thermal laser light is 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. These lasers have been developed by two of the world's leading laser companies, Coherent Inc., based in California, and the Carl Zeiss Group, based in Germany.
Visudyne therapy is being co-developed for various ocular conditions by CIBA Vision and QLT Inc. CIBA Vision markets the product worldwide while QLT is responsible for manufacturing. Visudyne therapy is protected by a series of U.S. and foreign-issued patents on composition of matter, formulations and manufacturing, and the method of use in treating AMD and other conditions.
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