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Glossary

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Aczone® is a product developed by QLT's wholly owned subsidiary, QLT USA, Inc. for the treatment of mild to moderate acne. It has both anti-microbial and anti-inflammatory properties.

age-related macular degeneration (AMD) is a disease of the eye's retina that can cause loss of central vision and make it difficult to recognize faces, read, drive and perform other everyday activities. AMD appears in two forms: dry and wet.

androgens are male hormones, such as testosterone.

angiogenesis is the formation/development of new blood vessels in the body. Angiogenesis is crucial to the development of glaucoma and macular degeneration.

antiandrogens are medications that block the testosterone receptor.

antibodies are a type of protein. They are produced by the immune system in response to foreign substances that may be a threat to the body, such as chemicals, virus particles, spores, or bacterial toxins. These foreign substances are called antigens. Each type of antibody is unique and defends the body against one specific type of antigen.

antigen is any substance that causes your immune system to produce antibodies against it. The antigen may be a foreign substance from the environment (such as chemicals, bacteria, viruses or pollen) or formed within the body (such as bacterial toxins or tissue cells).

anti-VEGF is defined as anti-vascular endothelial growth factor.

Astellas Pharma Inc. shares a marketing agreement with QLT for Eligard in Europe.

Atrigel® is a proven sustained-release drug delivery platform that delivers therapeutic levels of a wide spectrum of drugs over a few days to several months with a single injection.

 

B

benign prostatic hyperplasia (BPH) is the medical term for enlarged prostate. It is the most frequent urologic disorder in men over age 50. The condition is not malignant or inflammatory but is usually progressive and may lead to obstruction of the urethra and uncomfortable lower urinary tract symptoms.

biodegradable describes any material that can be broken down by biologic action.

biopharmaceutical companies use biotechnology to develop innovative drugs.

 

C

cancer is the name given to a group of diseases that are characterized by uncontrolled cellular growth.

choroid is the thin layer of blood vessels and connective tissue between the white of the eye (also known as the sclera) and the retina.

choroidal neovascularization (CNV) occurs when new blood vessels begin to grow from the choroid up to the retina. These new blood vessels are permeable, allowing blood and fluid to leak into the retina. This leakage may cause the retina to become swollen, impairing function of the retina and leading to poor central vision and visual distortion.

classic choroidal neovascularization (or classic CNV) is a form of age-related macular degeneration (AMD). This disease progresses more rapidly than occult CNV and is more aggressive and easier to diagnose because the vessels are well defined and therefore easier to detect on a fluorescein angiography. Loss of sight occurs more rapidly with classic CNV.

clinical protocol is a document that describes, at a minimum, the background, rationale, objective(s), design, methodology, statistical considerations and organization of a clinical study.

clinical trial is a research study of how a new drug or treatment works on a disease or helps patients; also known as a clinical study.

CMS is the Centers for Medicare and Medicaid Services.

combination therapy is a treatment using more than one drug.

control group is the group of patients receiving standard care for a disease rather than the clinical study treatment.

CPMP is the Committee for Proprietary Medicinal Products (a committee of the European Medicines Evaluation Agency).

 

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diabetic retinopathy is a condition associated with diabetes in which high blood sugar levels can damage blood vessels in the retina, the nerve layer at the back of the eye that senses light and helps to send images to the brain. The damage to retinal vessels is referred to as diabetic retinopathy.

drusen can appear as tiny, glassy deposits or large, "yellowish" fatty deposits behind the retina of the eye.

dry age-related macular degeneration (AMD) is characterized by fatty deposits on the back of the retina, called drusen. Dry AMD is extremely common but is only responsible for 10% of vision loss associated with the disease. This condition progresses slowly and tends to predispose a person to developing the more severe wet form of AMD. There are currently no treatments approved for dry AMD.

 

E

Eligard® is a member of a class of drugs known as leutinizing hormone-releasing hormone agonists, or LHRH agonists, and has been approved for the treatment of advanced prostate cancer. Eligard works by lowering the levels of testosterone in the body, which may result in a reduction of symptoms related to the disease.

 

F

fluorescein angiogram is a test used to assess the health of certain blood vessels in the eye. In this test, fluorescein dye is injected into a vein in the arm and photographs are taken of the eye as the dye circulates.

Food and Drug Administration (FDA) is the federal agency charged with approving all pharmaceutical and food ingredient products sold within the United States.

 

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ILK stands for integrin-linked kinase. ILKs are intracellular proteins that have been shown to mediate communication between cell pathways. Inhibition of the kinase activity of ILK has the potential of a broad range of clinical applications including cancer, inflammation, kidney and eye diseases.

inflammatory is defined as causing inflammation.

Investigational New Drug Application (INDA) is an application to the U.S. Food and Drug Administration (FDA) seeking approval to begin clinical studies of a new pharmaceutical product.

 

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LH-RH stands for luteinizing hormone-releasing hormone, a hormone that is produced by the hypothalmus, a tiny gland in the brain.

LH-RH agonists are synthetically made hormones, chemically similar to luteinizing hormone-releasing hormone (LH-RH). They block the production by the testicles of the male hormone testosterone and are sometimes used to treat prostate cancer.

lemuteporfin, formerly known as QLT0074, is a photosensitizer. QLT is currently exploring the use of this light-activated drug in a Phase IIB randomized trial for the treatment of benign prostatic hyperplasia (a form of prostate disease resulting in enlargement of the prostate).

lens, transparent body located behind the cornea that focuses the incoming light rays onto the retina.

leuprolide acetate is the active ingredient in Eligard (leuprolide acetate for injectable suspension).

 

M

Mayne Pharma PTY Ltd. holds the marketing rights for the Eligard six-month formulation in Australia and New Zealand.

macula is the small, specialized area of the retina responsible for central vision.

MediGene AG shares an exclusive European marketing agreement with QLT for the Eligard six-month formulation.

metastasis is defined as the spread of cancer cells to distant areas of the body by way of the lymph system or bloodstream.

minimally classic AMD is a form of wet age-related macular degeneration (AMD). If there are less than 50% classic lesions in a patient, it is referred to as minimally classic.

 

N

neovascularization is the abnormal growth of new blood vessels, usually in or under the retina or on the iris.

New Drug Application (NDA) is an application to the U.S. Food and Drug Administration (FDA) seeking approval of a new drug that has undergone Phase II and Phase III clinical trials. An NDA is submitted in the form of pages of data, along with various analyses of that data concerning efficacy and safety.

Novartis Ophthalmics shares an exclusive worldwide co-development and commercialization agreement with QLT for Visudyne.

 

O

occult choroidal neovascularization (or occult CNV) is less predictable than classic choroidal neovascularization or CNV. CNV leakage as shown on a fluorescein angiography is less obvious and is more difficult to diagnose. Roughly half of all patients with occult CNV will develop classic CNV within a year.

ocular histoplasmosis is caused by a fungal infection of the retina and can lead to severe, irreversible vision loss. It is a primary cause of blindness in adults who have lived in areas where the soil mold histoplasma capsulatum is found.

octreotide is an 8-amino acid synthetic peptide. It mimics a protein that occurs naturally in the body called somatostatin. Octreotide is being investigated for the treatment of acromegaly by which it might achieve blocking the excess production of growth hormone from the pituitary gland. It is also being studied for the treatment of the symptoms associated with carcinoid tumors. Octreotide may work in a wide range of medical conditions other than acromegaly and carcinoid syndrome because somatostatin is not limited to one area of the body or one type of tissue. The protein is expressed throughout the body, therefore it could prevent the formulation of irregular blood vessels in the eye, alleviate the symptoms related to carcinoid tumors in the bowels, or limit excess growth hormone from the pituitary gland.

ophthalmology is the branch of medicine concerned with the study of the physiology, anatomy and pathology of the eye and the diagnosis and treatment of disorders of the eye.

 

P

pathalogic myopia is a degenerative form of near-sightedness that occurs in people 30-50 years of age and results in progressive but unpredictable loss of vision.

pharmacokinetics is the study of the process by which a drug is absorbed, distributed, metabolized and eliminated by the body.

phase is a specific part of the clinical trial process, progressing from phase I to phase IV, during which dosing, benefits and side effects of a drug or treatment are studied.

Pfizer Inc. shares a research, collaboration and non-exclusive license with QLT for the use of the Atrigel drug delivery technology in combination with certain Pfizer proprietary compounds.

photodynamic therapy (PDT) is a proprietary method of using light to make a drug work. Using light activated drugs called photosensitizers, PDT can be used to treat diseases such as cancer and age related-macular degeneration (AMD) which feature rapidly growing tissues.

photosensitizer is a light-activated drug, such as Visudyne and lemuteporfin.

Photofrin® is the world's first approved photodynamic therapy drug used in the treatment of various cancers. QLT sold the rights to Photofrin to Axcan Pharma Inc. on June 8, 2000.

predominantly classic age related-macular degeneration (AMD). Predominantly classic lesions have a more lacy appearance in a standard angiography than occult lesions. Classic lesions are easier to diagnose because the vessels are well defined. If more than 50% of the lesions are classic, the disease is referred to as predominantly classic AMD.

prostate cancer is cancer of the prostate gland. Some prostate cancers grow and spread slowly, and others grow and spread quickly to other parts of the body, such as the lymph nodes, bone and seminal vesicles.

prostate gland is a walnut-sized male gland, located between the bladder and the penis, which surrounds the urethra. The prostate's function is to produce the fluid for semen.

prostate-specific antigen (PSA) is a protein produced by cells of the prostate gland. PSA circulates in the blood and can be measured with a simple blood test. PSA levels go up in the blood of some men who have prostate enlargement or prostate cancer.

 

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retina is the internal layer of the eyeball which contains the nerve necessary for receiving and trasmitting visual images.

 

S

Sandoz Inc. shares a development and commercialization agreement with QLT USA for certain generic dermatology products in the U.S.

Sanofi-aventis Group shares an exclusive North American marketing agreement with QLT for Eligard in prostate cancer.

sebaceous glands are glands in the skin that produce an oily substance called sebum. These glands are the sites of acne lesions. Sebaceous glands are attached to hair follicles and are found mostly on the face, neck, back and chest.

Solvent Microparticle System or SMP™ is a proprietary drug delivery technology that allows for the combination of dissolved drug and a microparticle suspension of the drug in one formulation, which effectively controls and prolongs drug delivery.

Sosei Co. Ltd. shares a marketing agreement for Eligard in Japan.

standard of care is a currently accepted and widely used treatment for a certain disease based on the results of past research.

subfoveal is located beneath the fovea, the central pit in the macula that produces sharpest vision.

systemic therapy is a treatment that consists of taking medication internally, such as in pill form or by injection or infusion.

 

T

testosterone is a male hormone produced mainly by the testicles. It stimulates a man's sexual activity and the growth of the sex organs, including the prostate.

T-IND is the acronym for treatment-investigational new drug, or expanded access.

triamcinolone is a glucocorticosteroid that is of interest for inhibiting the inflammatory component of choroidal neovascularization (CNV) in wet age-related macular degeneration (AMD) particularly in association with Visudyne. Researchers at the National Eye Institute (NEI) have developed a preservative-free triamcinolone acetonide (PFTA) specifically formulated for use in the eye and they are currently testing it in clinical studies.

 

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VEGF is the acronym for vascular endothelial growth factor. It is a naturally occurring protein that ischemic tissues - tissues lacking oxygen - secrete (as in age-related macular degeneration). Research has shown that when VEGF is introduced to endothelial cells, it stimulates the development of new blood vessels. It can directly promote the growth and survival of malignant tumor cells.

Visudyne® (verteporfin) is an innovative product that uses photodynamic therapy, or light-activated therapy, for the treatment of wet age-related macular degeneration (AMD), pathologic myopia and presumed ocular histoplasmosis.

 

W

wet age related-macular degeneration (AMD) is a devastating disease that causes a loss of central vision. It is caused by choroidal neovascularization, or CNV, a growth of abnormal blood vessels under the central part of the retina, called the macula. This condition progresses rapidly resulting in a severe deterioration of sight, unless otherwise treated. Over the next 20 years, as the population ages, the number of wet AMD cases is expected to grow by 50%, according to the Eye Disease Prevalence Research Group.

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