Scottish Medicines Consortium accepts OZURDEX® (dexamethasone 700mcg intravitreal implant) for use within NHS Scotland
Marlow, UK, 11 June 2012 - Allergan is pleased to announce that the Scottish Medicines Consortium (SMC) has accepted OZURDEX® (dexamethasone 700 microgram intravitreal implant) for use in the National Health Service in Scotland. The treatment is now accepted for use in adult patients with macular oedema following central retinal vein occlusion (CRVO) and in patients with branch retinal vein occlusion (BRVO) who are not clinically suitable for laser treatment including patients with dense macular haemorrhage or patients who have received and failed on previous laser treatment.
This decision is particularly important for Scottish patients with BRVO who until now have not had access to a reimbursed pharmacological treatment option. In contrast, RVO patients in England and Wales are currently able to access OZURDEX® treatment following Guidance from National Institute for Health and Clinical Excellence (NICE) in July 2011.
OZURDEX® is an innovative biodegradable eye implant that delivers the anti-inflammatory medication dexamethasone into the back of the eye using a specially designed applicator. Unlike other treatments for RVO, a single injection of OZURDEX® is effective for up to six months1 requiring less frequent injections into the eye, with the potential for improved use of NHS resources. This results in an overall lower burden of treatment, which may offer a significant benefit to patients and carers.
Mr Tariq Saboor, Consultant Ophthalmologist Surgeon at Forth Valley NHS Trust said "'The availability of a licensed, effective and now SMC accepted treatment is a significant step forward for management of RVO patients in Scotland. Having access to a treatment that tackles the significant inflammation and swelling resulting from blocked retinal veins is good news for my patients. The fact that the treatment only needs to be administered up to every 6 months is also a significant advantage."
Assessed in the largest completed RVO clinical trials programme in over 1,000 patients, OZURDEX® significantly improved vision by 3 lines or more (or 15 letters) on an eye chart in up to 29% of patients with macular oedema due to RVO following just one injection.2 In some patients this improvement was maintained for up to 6 months.1 Importantly, OZURDEX® was also shown to improve or stabilise vision (defined as >0 letters change on an eye chart) in more than 80% of patients.3 Side effects associated with OZURDEX® included discomfort on administration, bruising or bleeding on the surface of the eye, and a rise in eye pressure that was successfully treated with topical intraocular pressure (IOP)-lowering medication in the majority of patients.4
RVO, an important and common cause of vision loss, occurs when a retinal vein becomes blocked (occluded).5 This occlusion leads to a build-up of fluid in the retina and thickening of the macula (called macular oedema). Macular oedema is a self-propagating process that develops as a consequence of the interaction between inflammation, angiogenesis (growth of new blood vessels), and vascular leakage.6,7 Recent studies have shown that retinal inflammation is a relatively early event in the pathophysiology of macular oedema, occurring before vascular dysfunction and fluid accumulation.8
BRVO affects five people in every 1,000 over the age of 30 while CRVO affects 1 person in every 1,250.9 This means that more than 9,000 people in Scotland are likely to have RVO.9,10 RVO can impact on patients' ability to do everyday things, such as reading a newspaper, watching a film or driving.11 Visual impairment resulting from RVO can cause significant direct healthcare costs, as well as indirect costs to patients, their family and society, such as loss of income and costs to adapt a person's home.12,13 "Allergan is pleased that the SMC has accepted OZURDEX® as a cost effective treatment for patients with retinal vein occlusion* in Scotland, and we are looking forward to working closely with the Scottish NHS to implement the SMC recommendation as quickly as possible," said Dr Selwyn Ho, Country Manager for Allergan UK.
About Allergan, Inc.
Allergan is a multi-specialty health care company established more than 60 years ago with a commitment to uncover the best of science and develop and deliver innovative and meaningful treatments to help people reach their life's potential. Today, we have more than 10,000 highly dedicated and talented employees, global marketing and sales capabilities with a presence in more than 100 countries, a rich and ever-evolving portfolio of pharmaceuticals, biologics, medical devices and over-the-counter consumer products, as well as state-of-the-art resources in R&D, manufacturing and safety surveillance that help millions of patients see more clearly, move more freely and express themselves more fully. From our beginnings as an eye care company to our focus today on several medical specialties, including ophthalmology, neurosciences, medical aesthetics, medical dermatology, breast aesthetics, obesity intervention and urologics, Allergan is proud to celebrate more than 60 years of medical advances and proud to support the patients and physicians who rely on our products and the employees and communities in which we live and work.
Janet Kettels: +44 (0)7738 5064 76 or email@example.com
Sarra Martin: +44 (0)7540 720 466 or firstname.lastname@example.org
® and ™ Marks owned by Allergan, Inc.
*Ozurdex® is accepted by the Scottish Medicines Consortium for use in adult patients with macular oedema following central retinal vein occlusion (CRVO) and in patients with branch retinal vein occlusion (BRVO) who are not clinically suitable for laser treatment including patients with dense macular haemorrhage or patients who have received and failed on previous laser treatment
- Haller JA, Bandello F, Belfort R, et al. Ophthalmology 2011;118:2453–60.
- Haller JA Bandello F, Belfort R, et al. Ophthalmology 2010;117:1134–46.
- Allergan data on file 4B-65.
- OZURDEX® Summary of Product Characteristics, www.medicines.org.uk/emc/.
- Royal College of Ophthalmologists. Interim Guidelines for Management of Retinal Vein Occlusion. December 2010.
- Johnson MW. Am J Ophthalmol 2009;147:11–21.
- Yoshimura T, Sonoda KH, Sugahara M, et al. Comprehensive analysis of inflammatory immune mediators in vitreoretinal disease. PLoS ONE 2009;4:e8158. doi:10.1371/journal.pone.
- Scholl S, Augustin A, Loewenstein A, et al. Eur J Ophthalmol 2011;21(Suppl. 6): S10–S19.
- Rogers S et al. Ophthalmology 2010;117:313–9.
- National Records of Scotland. Mid-2010 Population Estimates Scotland. Population estimates by sex, age and administrative area. Published 27 April 2011
- Deramo VA, Cox TA, Syed AB, et al. Arch Ophthalmol 2003;121:1297–302.
- Future sight loss UK (1):.The economic impact of partial sight and blindness in the UK adult population. Executive summary. RNIB June 2009.
- Lafuma A, Brézin A, Lopatriello S, et al. Pharmacoeconomics 2006;24:193–205.