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Published on 29 September 2014

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FDA approval for ILUVIEN® in DME strengthens Alimera Sciences in global ophthalmology arena

Alimera Sciences Inc., a pharmaceutical company that specialises in the research, development and commercialisation of prescription ophthalmic pharmaceuticals, today announced that the US Food and Drug Administration (FDA) has approved ILUVIEN® for the treatment of diabetic macular oedema (DME). This comes nearly 18 months after the treatment became available in the UK and Germany, having received an approvable response via the European Decentralised Procedure in February 2012.

Alimera Sciences Inc., a pharmaceutical company that specialises in the research, development and commercialisation of prescription ophthalmic pharmaceuticals, today announced that the US Food and Drug Administration (FDA) has approved ILUVIEN® for the treatment of diabetic macular oedema (DME). This comes nearly 18 months after the treatment became available in the UK and Germany, having received an approvable response via the European Decentralised Procedure in February 2012.

ILUVIEN is already approved for marketing in Austria, Denmark, France, Germany, Italy, Norway, Portugal, Spain and Sweden, and is commercially available in the UK and Germany. The US approval further cements the important role for ILUVIEN in patients with DME and confirms Alimera Sciences’ commitment to become a global ophthalmology company.

This is a major milestone for Alimera Sciences, delivering further momentum to our geographic expansion, but more importantly providing a long-term treatment option for American patients with DME,” said Philip Ashman, Ph.D., Senior Vice President and European Managing Director. “The in-market experience of ILUVIEN in Europe has grown strongly in 2014, to the point where more patients have now been treated in the clinic than were treated in the development program. Anecdotal feedback from ophthalmologists has been very encouraging, and we anticipate continued growth in the use of ILUVIEN. The news from the FDA only adds to our confidence that ILUVIEN will become an important global brand in ophthalmology.”

Commenting on the approval, Professor Yit C. Yang, Consultant Ophthalmic Surgeon from Wolverhampton Eye Infirmary and Birmingham & Midland Eye Centre, said: “The FDA approval of ILUVIEN is really positive news for the retinal community in the US, as having a low-dose corticosteroid intravitreal implant that lasts up to three years will provide an additional treatment option for patients with diabetic macular oedema. This is also significant news for clinicians and patients globally, as we seek to ensure the best standards of care in clinical practice and standardization of guidance on the management of this disease.”

The Company expects to begin selling ILUVIEN in the US market during the first quarter of 2015. ILUVIEN is pending approval in an additional seven European countries: Belgium, the Czech Republic, Finland, Ireland, Luxembourg, the Netherlands and Poland.



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