Alimera Sciences, a biopharmaceutical company has announced the positive outcome of the Decentralized Procedure (DCP) for Iluvien in Europe.
The announcement follows the issuance of the Final Assessment Report from the Reference Member State (RMS), and the Medicines and Healthcare products Regulatory Agency of the UK (MHRA).
It also follows the agreement of all the Concerned Member States (CMS), which include Austria, France, Germany, Italy, Portugal and Spain, that ILUVIEN is approvable.
Iluvien will be indicated for the treatment of vision impairment associated with chronic DME considered insufficiently responsive to available therapies, said the company.
Alimera Sciences president and chief executive officer Dan Myers said achieving a favorable conclusion for ILUVIEN in Europe is a significant milestone for Alimera and very encouraging for the many patients with this challenging chronic disease
"We will continue to work closely with the UK and the Concerned Member States to ensure that ILUVIEN is made available to patients as soon as possible," Myers said.
Iluvien is an intravitreal implant that releases sub-microgram levels of fluocinolone acetonide (FAc) for up to 36 months for the treatment of chronic DME.
After receiving the ILUVIEN implant, 38% patients with chronic DME at month 30 experienced an improvement from baseline in their best corrected visual acuity on the Early Treatment of Diabetic Retinopathy Study (ETDRS) eye chart of 15 letters or more, according to the clinical trial data.
Thirty-four per cent had achieved the same result at the completion of the 36-month study.
Alimera Sciences senior vice president of sales and marketing Dave Holland said their market research indicates that, given DME is a leading cause of blindness in working-age adults, there is a significant opportunity for an effective ophthalmic drug to treat patients insufficiently responsive to available therapies.
"An effective, truly long-term treatment option could have a very positive impact on the quality of life for patients with this chronic debilitating disease," Holland said.