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Alimera Sciences (NASDAQ:ALIM) has announced it has launched ILUVIEN in Germany to prevent relapse in recurrent non-infectious uveitis affecting the posterior segment of the eye (NIPU). As quoted in the press release: Following the European Union’s Mutual Recognition Procedure in March 2019, Germany is the second country in Europe in which ILUVIEN is now commercially …
Alimera Sciences (NASDAQ:ALIM) has announced it has launched ILUVIEN in Germany to prevent relapse in recurrent non-infectious uveitis affecting the posterior segment of the eye (NIPU).
As quoted in the press release:
Following the European Union’s Mutual Recognition Procedure in March 2019, Germany is the second country in Europe in which ILUVIEN is now commercially available to be prescribed to patients suffering from NIPU, a disease with no sustained treatment options. In June 2019, Alimera announced a positive recommendation by the National Institute for Health and Care Excellence (NICE), facilitating launch of the NIPU indication in the United Kingdom.
“New therapeutics for non-infectious uveitis are urgently needed, as there are few options available while potential for vision loss is very real. The availability of ILUVIEN now provides a long-acting, intravitreal treatment option for our patients that closes a gap in the care needs of this chronic disease,” said Professor Dr. med. Carsten Heinz FEBO, Augenzentrum am St. Franziskus-Hospital, Munster, Germany. “ILUVIEN has a well-established efficacy and safety profile for the continuous treatment of diabetic macular edema and now patients with non-infectious uveitis affecting the posterior segment can expect similar benefits and – due to the local application – no occurrence of the unwanted systemic effects of long-term corticosteroid therapy.”
Launch of the NIPU indication follows the establishment of national pricing and receipt of the required regulatory approval by the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte or BfArM), the medical regulatory authority in Germany. Germany is Alimera’s largest direct market in Europe based on current sales for ILUVIEN’s diabetic macular edema (DME) indication, and it is estimated that the number of patients diagnosed with NIPU is approximately 15-20% of the DME patient population.
