Ozurdex (dexamethasone) can now be used for the treatment of inflammation of the posterior segment of the eye characterized as non-infectious uveitis
Ozurdex (dexamethasone) can now be used for the treatment of inflammation of the posterior segment of the eye characterized as non-infectious uveitis, announced Allergan.
The drug is available in the majority of Europe as a licensed treatment for macular oedema in patients with retinal vein occlusion. The biodegradable implant gives an extended release of the anti-inflammatory corticosteroid dexamethasone by intravitreal injection, lasting for up to 6 months. The injection is administered with Allergan's NOVADUR solid polymer delivery system.
The safety and efficacy of Ozurdex was assessed in the HURON Phase III study. This was a randomized, multicentred, double-masked clinical investigation of 229 patients with non-infectious intermediate or posterior uveitis. Each patient was administered 0.35 mg or 0.7 mg of Ozurdex or sham injections.
The results of the study demonstrated a reduction in vitreous haze, an improvement in visual acuity and an overall improvement in vision functioning.
Mr Douglas Ingram, President of Allergan, Europe, Africa and the Middle East, said: “We are pleased with the Committee’s Positive Opinion today supporting the licensure of Ozurdex to treat non-infectious intermediate and posterior uveitis. This is a crucial step in the process to bring this innovative anti-inflammatory treatment option to physicians and their patients suffering from uveitis. This is also an important milestone for Allergan’s Retina franchise and demonstrates our continuing commitment to developing innovative new treatments that can help preserve vision for patients suffering from retinal diseases."