Alimera has designed the ILUVIEN to release submicrogram levels of fluocinolone acetonide, to reduce the recurrence of disease, helping patients maintain vision
Image: The ILUVIEN is deigned to release submicrogram levels of fluocinolone acetonide. Photo: Courtesy of Sofie Zbořilová from Pixabay.
Alimera Sciences has announced its plans to launch the ILUVIEN in Germany for the prevention of relapse in recurrent non-infectious uveitis affecting the posterior segment of the eye (NIPU).
With the launch of ILUVIEN in Germany, the implant is now available in two countries in Europe to be prescribed to patients suffering from NIPU.
In June 2019, Alimera has secured a positive recommendation from the National Institute for Health and Care Excellence (NICE), to launch its NIPU indication in the UK.
Professor Carsten Heinz from Augenzentrum Franziskus-Hospital, Munster, Germany said: “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.
“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.”
ILUVIEN is injected into the back of the eye
ILUVIEN 0.19 mg is a sustained release intravitreal implant, developed using continuous microdosing technology, and is injected into the back of the eye.
The company said that it has designed the ILUVIEN to release submicrogram levels of fluocinolone acetonide, to reduce the recurrence of disease, helping patients maintain vision.
In addition, its ILUVIEN is approved in the US, Canada, Kuwait, Lebanon and the UAE to treat diabetic macular edema (DME) in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure.
Prior to the launch of ILUVIEN, , the company has secured the national pricing and required regulatory approval from the Bundesinstitut für Arzneimittel und Medizinprodukte (Federal Institute for Drugs and Medical Devices), the medical regulatory authority in Germany.
In March, ILUVIEN received approval in the 17 European countries under the Mutual Recognition Procedure.
Alimera Sciences president and CEO Rick Eiswirth said: “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.
“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 non-infectious posterior uveitis or DME.”