Alimera Sciences Launches Iluvien in Germany For Noninfectious Uveitis
Alimera Sciences announced that it will immediately commence the launch of Iluvien in Germany for the prevention of relapse in recurrent noninfectious uveitis affecting the posterior segment of the eye (NIPU). 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 noninfectious 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,” Professor Dr. med. Carsten Heinz FEBO, Augenzentrum am St. Franziskus-Hospital, Munster, Germany, said in a company news release. “Iluvien has a well-established efficacy and safety profile for the continuous treatment of diabetic macular edema and now patients with noninfectious 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.
“The launch in Germany represents our second country rollout for Iluvien’s expanded European indication for uveitis, a retinal disease that anti-VEGF drugs do not treat,” Rick Eiswirth, president and CEO of Alimera Sciences, said in the news release. “We continue to receive encouraging feedback from physicians regarding Iluvien’s unique continuous Microdosing technology, with its ability to reduce the recurrence of disease in patients diagnosed with either noninfectious posterior uveitis or DME.”