European green light for Allergan’s Ozurdex
pharmafile | May 25, 2010 | News story | Sales and Marketing | Allergan, CHMP, Ozurdex, macular oedema
European authorities have given the green light for Ozurdex, a treatment for adults with a potentially serious eye disease.
Ozurdex (dexamethasone), made by Allergan Pharmaceuticals Ireland, is indicated for adult patients with macular oedema following either branch retinal or central retinal vein occlusion.
The Committee for Medicinal Products for Human Use (CHMP) recommended that the European Commission grants marketing authorisation for the drug, following a review which began on 25 March last year.
The macula sits at the centre of the back of the retina, an area which has a major impact on determining sharpness of vision.
Macular oedema occurs when fluid accumulates within the retina due to leakage, causing the macula to become thickened. The reduction in vision is reversible if tackled early, but a prolongued problem can result in permanent vision loss.
A widely used corticosteroid, dexamethasone acts on and inhibits key elements in the macular oedema’s vision loss process, such as capillary leakage.
The CHMP says Ozurdex prolongs the duration of dexamethasone’s effect in the eye, with the 700 microgram biodegradable implant delivering the gradual release dose over time.
It is suggested that it should be administered by a qualified ophthalmologist who is experienced in intravitreal injections.
Safety and efficacy was assessed in two randomised, double-masked studies in patients, with the most common side effects increased intraocular pressure and conjunctival haemorrhage.
A pharmacovigilance plan for Ozurdex will be put in place as part of the marketing authorisation.
Allergan, the US company behind so-called ‘cosmaceutical’ products such as Botox and silicon breast implants, shut its manufacturing facility in Arklow, Ireland last year, moving production to Costa Rica.
But one of its biggest facilities worldwide remains in the western Irish town of Westport, employing 750 people and manufacturing ophthalmic and neurological products.
The company’s European shared services centre is based in Dublin
Adam Hill
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