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Published on 3 September 2014

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OZURDEX® authorised for use in the EU for DMO

Allergan announced that the European Commission has extended the Marketing Authorisation for OZURDEX® (dexamethasone 700mcg intravitreal implant in applicator) to treat adult patients with visual impairment due to diabetic macular oedema (DMO) who are pseudophakic (have an artificial lens implant), or who are considered insufficiently responsive to, or unsuitable for non-corticosteroid therapy. (2)

 

Allergan announced that the European Commission has extended the Marketing Authorisation for OZURDEX® (dexamethasone 700mcg intravitreal implant in applicator) to treat adult patients with visual impairment due to diabetic macular oedema (DMO) who are pseudophakic (have an artificial lens implant), or who are considered insufficiently responsive to, or unsuitable for non-corticosteroid therapy. (2)

 

DMO is a common complication in people with diabetes. (3,4) In patients with DMO, inflammation can cause swelling and fluids to leak into the macular (the part of the eye where fine vision occurs), which can lead to blurred vision, vision loss and eventual blindness, if left untreated. (5)

Current estimates indicate that approximately 200,000 people in the UK are living with DMO. (6,7) These patients often have other health issues (8) which can result in the need for frequent visits to a wide range of healthcare professionals. (5) Effective but less frequent treatments for DMO, like OZURDEX®, could be advantageous for certain patients, (9) their caregivers and the healthcare system.
Within the context of the global diabetes epidemic, Allergan is pleased to bring another important treatment option to retinal specialists in their battle to save sight in diabetic patients,” said Esther Hayward, Allergan UK Country Manager. “This licence extension for OZURDEX® demonstrates our commitment to innovative R&D programs which allows us to continually bring forth new treatment options for physicians and their patients while delivering value to our stockholders.”

The safety and efficacy of OZURDEX® in the management of patients with DMO was assessed in the MEAD clinical trials program; (2,1) These consisted of two 3-year, multi-centre, double-masked, randomised controlled phase III studies of over 1000 patients who received either 350mcg or 700mcg of OZURDEX® or sham (simulated) injections.

 

The results showed that:
•    The percentage of patients with a 15 or more letter gain was significantly greater in those treated with OZURDEX® than sham at 3 years. (1)
•    Meaningful treatment benefit was observed with a mean of 4 to 5 injections over 3 years. (1)
•    Rapid onset of treatment benefit was observed after the first and repeated OZURDEX® injections. (1)
•    Treatment with OZURDEX® (700mcg) was generally well tolerated with manageable adverse effects.

 

OZURDEX® demonstrated good systemic safety.  Common adverse events included elevated intraocular pressure and cataract, consistent with previous observations. (1)
Commenting on the authorisation Professor Yit Yang, Consultant Ophthalmic Surgeon from Wolverhampton Eye Infirmary and Birmingham and Midland Eye Centre says, “This is good news because OZURDEX® therapy can potentially improve the quality of life for patients with DMO by resolving their macular oedema, improving their visual function for daily activities such as reading and driving and by reducing the burden of very frequent hospital visits with just four to five injections required over 3 years.”

Developed for the treatment of retinal disease, OZURDEX® is a biodegradable implant containing dexamethasone – an anti-inflammatory corticosteroid – in a specially designed single use applicator. Following an intravitreal injection into the back of the eye, the implant slowly dissolves and releases the dexamethasone directly to the retina over a period of several months. (2)

 

In DMO, dexamethasone works by suppressing inflammation, reducing the macular oedema (swelling) and improving visual acuity. (1)  OZURDEX® (dexamethasone 700mcg intravitreal implant in applicator) is already available in the UK as a treatment licenced for macular oedema in patients with retinal vein occlusion (RVO) and for inflammation of the posterior segment of the eye characterised as non-infectious uveitis. (2)

References
1.    Boyer DS et al. Three-year, randomized, sham-controlled trial of dexamethasone intravitreal implant in patients with diabetic macular edema. Ophthal 2014: 1-11 Epub ahead of print
2.    Allergan Ltd. Ozurdex Summary of Product Characteristics.  August 2014. https://www.medicines.org.uk
3.    Petrella RJ, et al. Prevalence, Demographics, and Treatment Characteristics of Visual Impairment due to Diabetic Macular Edema in a Representative Canadian Cohort. Journal of Ophthalmology. 2012;2012:159167.
4.    Mohamed Q, et al. Management of diabetic retinopathy: a systematic review. JAMA 2007;298:902–16147:11–21.
5.    Chen E, et al. Burden of illness of diabetic macular edema: literature review. Current Medical Research & Opinion 2010;26(7):1587–1597.
6.    Diabetes Prevalence 2013 – Diabetes UK 2014.  www.Diabetes.org.uk
7.    Yau JW, et al. Global prevalence and major risk factors of diabetic retinopathy. Diabetes Care 2012;35:556-564
8.    Fowler M. Microvascular and Macrovascular Complications of Diabetes. Clinical Diabetes. 2008;26(2):77–82.
9.    Sharipo A, et al. Clinical Trials in the Anti-VEGF Era. 2001. Available from: http://www.oraclinical.com/articles/clinical-trials-anti-vegf-era Accessed September 2014.



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