Elements for a Public Summary. Overview of disease epidemiology

Transcription

1 VI.2 VI.2.1 Elements for a Public Summary Overview of disease epidemiology Epidemiology of the disease Incidence and prevalence Increased pressure in the eye occurs in more than 100 million people, and can cause a disease called glaucoma. One form of glaucoma is primary open angle glaucoma (POAG), causing blindness in more than 3 million people worldwide and about 2.4 million new cases occur each year. Increased pressure in the eye is times more common than POAG. PhV Page 70/106

2 Primary congenital glaucoma (PCG) is the commonest glaucoma in children, but it occurs with a different frequency worldwide. Groups that are at higher risk than others age, sex, race/ethnic origin. Gender The risk of developing POAG is the same for both sexes. However, women are at a greater risk than men of developing another form of the disease, angle-closure glaucoma. More women than men have increased pressure in the eye. Age Increasing age is a definite risk factor. As you get older the risk of POAG increases. There are 3-10 times more people over the age of 80 years with POAG than people in their 40s. The risk of developing increased pressure in the eye increases over the age of 40 years. In children with glaucoma, more than 80% patients developed glaucoma within the first year of life, with 25% diagnosed within the first month after birth and 60% within the first 6 months of life. Race African Americans are at greater risk of developing POAG. It occurs 3-6 times more often in African Americans than in whites. Glaucoma usually occurs earlier in African Americans than in whites. African Americans not only are 4-8 times more likely to become blind but also go blind 8 times faster. The frequency of open angle glaucoma in Latinos is higher than in non-hispanic whites, but lower than in Afro-Caribbeans. Less is known about the frequency of increased pressure in the eye. Risk factors for the disease Visual problems, blindness Main treatment options The ideal drug for the treatment of high pressure in the eye should lower the pressure in the eye, have no side effects, be cheap, and have once-a-day dosing. Antiglaucoma, Prostaglandin Agonists (e.g. latanoprost, bimatopost, tafluprost) Antiglaucoma, Beta-Blockers (e.g. betaxolol, carteolol, timolol) Antiglaucoma, Carbonic Anhydrase Inhibitors (e.g. dorzolamide, brinzolamide, acetazolamide, methazolamide) Antiglaucoma, Alpha Agonists (e.g. brimonidine, apraclonidine) Antiglaucoma, Combos (e.g. brimonidine/timolol, timolol/dorzolamide) Surgery is the definitive treatment modality for the control of intraocular pressure (IOP) in paediatric glaucoma, although medical treatment is first line in secondary glaucoma, because it is often successful in reducing IOP short term. Eye problems and blindness Glaucoma Glaucoma is the second most common cause of blindness in the United States, and it is the main cause of blindness in African Americans. Between 80, ,000 people are blind due to glaucoma, and each year, a further 5,500 people are likely to become blind. At least 2.25 million people older than 40 years have glaucoma, but only one half are aware of it and are being treated. Increased pressure in the eye PhV Page 71/106

3 In 3% of patients with increased eye pressure, the blood vessels in the retina may become blocked or damaged resulting in eye problems and blindness. The development of glaucoma is the main reason for problems in the eye which may lead to blindness. Studies have shown that over a 5-year-period, the occurrence of damage caused by glaucoma increases with rising eye pressure levels. VI.2.2 Summary of treatment benefits belongs to a group of medicines called prostaglandin analogues. These medicines lower the pressure in the eye and are used to treat high eye pressure and glaucoma. Like other medicines in this group, reduces the pressure within the eye by improving the flow of eye liquid (called aqueous humor) from the eyes through their drainage channels. significantly reduces eye pressure with an effect lasting throughout a 24 hour period, and still persisting up to 84 hours after using the medicine. provides a safe and effective reduction of pressure in the eye with a convenient once-a-day dose, making the main drug of choice. 26 VI.2.3 Unknowns relating to treatment benefits Based on the information currently available, no further studies are needed on how well travoprost works. There is also no evidence to suggest that factors such as age, sex, race or organ disease affect how well travoprost works in the people most likely to take it. VI.2.4 Summary of safety concerns Important identified risks Risk What is known Preventability Swelling in part of the eye () Changes in eye colour () Excessive hair growth (Hypertrichoses) occurs when a part of the eye called the macula becomes swollen, causing your vision to become blurred or distorted. Less common symptoms include object distortion, objects appearing smaller than they actually are, a blind spot, and intolerance to light. may gradually change the colour of the eye by increasing the amount of pigment in it. This change in eye colour happens especially if your eye colour is mixed i.e., blue-brown, grey-brown, yellow-brown and green-brown; however, this may also happen if your eye colour is brown. These changes appear to be cosmetic and have no harmful effect on your eyesight or health. Most patients using for 6 months or more will experience some degree of eyelash changes (increase in eyelash number/length/thickness). These changes are cosmetic and do not harm your vision or health. Caution should be taken when using travoprost in patients with known risk factors for macular oedema. Patients must be informed before starting treatment that their eye colour may possibly change permanently. If only one eye is treated, the colour of the treated eye may become permanently different from the untreated eye. Reaction included in the SmPC. PhV Page 72/106

4 Inflammation of the iris and eye (Iris and uveal inflammation) Heart and blood vessel problems (Cardiac and vascular disorders) Breathing problems () Allergic reactions (Hypersensitivity reactions) Inflammation of the iris is an uncommon side effect. The inflammation is usually mild and goes away when the patient stops using, with or without the help of anti-inflammatory drugs. Elderly patients and patients with existing heart and blood vessel problems have reported side effects such as irregular heartbeat, palpitations, decrease or increase in blood pressure, low or high blood pressure, and slow or fast heartbeat. However, these are uncommon. such as difficulty breathing, tightening of the air passages, sore throat, cough, voice problems, nasal congestion and throat irritation are uncommon side effects of. must not be given in patients who are allergic to travoprost or any of the other ingredients of this medicine. Allergic reactions such as: eye redness, itchy eye, eye irritation are known common side effects, while eyelid redness, swelling around the eye, eyelid itching may affect up to 1 in 100 people. If you have a history of inflammation in the eye you should use this medicine or other prostaglandin analogues should be used with caution in eyes with a history of iris inflammation, or with risk factors for iris inflammation. Also, it is not advisable to use or other prostaglandin analogues again if they have previously caused iris inflammation. Information regarding cardiovascular disorders is described in the SmPC. Information regarding respiratory disorders is described in the SmPC. Yes, by performing a medical examination before starting the treatment in patients with known drug allergies. Important potential risks Risk Eye/skin cancer (Ocular/skin melanoma) Inflammation of the cornea, which could lead to perforation and blindness What is known (Including reason why it is considered a potential risk) Melanoma is a very serious cancer especially if it spreads to skin or distant lymph nodes. There is no evidence of a link between and eyemelanoma. Benzalkonium chloride is a chemical commonly used to preserve eye medication. This chemical has been reported to cause spots and/or lesions on the cornea. Benzalkonium chloride can accumulate in eye tissue and remain there for a long time, making any side effects last longer in the cornea. PhV Page 73/106

5 Use during pregnancy and lactation Risk between and other drugs Long-term safety in the paediatric population has harmful effects on the mother and child during pregnancy. It is not known if this drug passes into human breast milk. Animal studies have shown that and its metabolites do pass into breast milk. What is known Interactions with other pressure reducing medicines or topical non-steroidal anti-inflammatory drugs (NSAIDs) cannot be ruled out. There are three possible effects from such an interaction, an increase in drug effect a reversed effect, resulting with an increased pressure within the eye (with other pressure reductive agents) a decreased effect (with topical NSAIDs) No interaction studies have been performed. can be used in children from 2 months of age at the same dose as for adults, but it is not recommended to those children under 2 months of age. In a study it was demonstrated that in children and adolescents, the most common side effects seen with travoprost are eye redness and growth of eyelashes. Both side effects were observed with a higher frequency in children and adolescents compared to adults. Long-term safety of travoprost was not studied. VI.2.5 Summary of risk minimisation measures by safety concern All medicines have a Summary of Product Characteristics (SmPC) which provides physicians, pharmacists and other health care professionals with details on how to use the medicine, the risks and recommendations for minimising them. An abbreviated version of this in lay language is provided in the form of the package leaflet (PL). The measures in these documents are known as routine risk minimisation measures. This medicine has no additional risk minimisation measures. VI.2.6 Planned post authorisation development plan No post-authorisation safety or efficacy studies are ongoing or are planned to be conducted for travoprost. VI.2.7 Summary of changes to the Risk Management Plan over time Major changes to the Risk Management Plan over time Version Date Safety Concerns Comment 2.0 Not approved Identified Risks Hypertrichoses PhV Page 74/106

6 Version Date Safety Concerns Comment Cardiovascular disorders Ocular and skin melanoma Long term use of preserved eye drops Pregnancy and lactation 3.0 Not approved Identified Risks Cardiovascular disorders Version 3.0 is an update of version 2.0 in relation to an assessment report from RMS. Ocular and skin melanoma Punctuate and/or toxic ulcerative keratopathy (from long-term use of BAK preserved eye drops) Pregnancy and lactation Safety in patient below 18 years 4.0 Approved Identified Risks Hypertrichoses Cardiac and vascular disorders Version 4.0 is an update of version 3.0 in relation to an assessment report from RMS. Ocular and skin melanoma Corneal damage and hypersensitivity due to long term use of preserved eye drops Use during pregnancy and lactation PhV Page 75/106

7 Version Date Safety Concerns Comment 5.0 Current version Identified Risks Hypertrichoses Cardiac and vascular disorders Hypersensitivity reactions Ocular/skin melanoma Corneal damage and hypersensitivity due to long term use of preserved eye drops Use during pregnancy and lactation Long-term safety in the paediatric population Version 5.0 is an update of version 4.0 in relation to a PRAC PSUR assessment report (procedure no.: EMEA/H/C/PSUSA/ /201502) Two new safety concerns were added: Hypersensitivity reactions (important identified risk) and Long-term safety in the paediatric population (). A new indication in paediatric population has been approved and relevant sections have been updated PhV Page 76/106