Two Ophthalmic Drugs Receive Positive Nods in Europe

Miriam E. Tucker


January 23, 2015

The European Medicines Agency's Committee for Medicinal Products for Human Use has recommended approval of ciclosporin eye drops (Ikervis, Santen SAS) for the treatment of severe keratitis in adults with dry eye disease.

The 1 mg/mL ciclosporin drops belong to the immunosuppressant therapeutic class of ophthalmologicals. They block the release of proinflammatory cytokines, reducing inflammation in ocular surface cells and possibly preventing disease progression and worsening.

The specific indication is: "Treatment of severe keratitis in adult patients with dry eye disease, which has not improved despite treatment with tear substitutes."

The most common adverse effects of the drops are eye pain (19%), eye irritation (17.8%), lacrimation (6.2%), ocular hyperemia (5.5%), and eyelid erythema (1.7%).

The drops must be prescribed by an ophthalmologist or a healthcare professional qualified in ophthalmology.

In a separate decision, the committee also adopted a positive opinion for a new indication for aflibercept (Eylea, Bayer Pharma AG) for "treatment of adults with visual impairment due to macular oedema secondary to branch retinal vein occlusion."

Aflibercept is already approved in the European Union for the treatment of adults with neovascular age-related macular degeneration, visual impairment resulting from macular edema secondary to retinal vein occlusion, and visual impairment caused by diabetic macular edema.


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