Sep 28 2015
Alimera Sciences Limited, the European subsidiary of Alimera Sciences, Inc. (NASDAQ: ALIM) (Alimera), a pharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, announced the availability of real world data from 28 injections of ILUVIEN® (Fluocinolone Acetonide 190 micrograms intravitreal implant in applicator) in Europe, presented in a review paper authored by Fahd Quhill, Consultant Ophthalmologist, Department of Ophthalmology, Royal Hallamshire Hospital, Sheffield, South Yorkshire, U.K.
The paper, entitled "Real World Experience of Fluocinolone Acetonide (0.2 micrograms/day) Intravitreal Implant in the Treatment of Diabetic Macular Edema," reviews 28 cases from six sites in the U.K. and four sites in Germany, the first two countries in which ILUVIEN was launched by Alimera Sciences Limited.
The mean follow up after injection of ILUVIEN was 13 weeks in these case reports. The average change in the Early Treatment Diabetic Retinopathy Study (ETDRS) letter score from baseline was an increase of 14 letters, with 15 eyes (54%) achieving greater than 10 letters of improvement and nine eyes (32%) achieving greater than 15 letters improvement. The average decrease in central foveal thickness (CFT) was 167 microns, while in 15 eyes (54%) CFT decreased to below 300 microns.
In these cases, each eye had received prior treatment, with 57% having been treated with corticosteroid, 57% having been treated with laser and 93% having been treated with anti-vascular endothelial growth factor (anti-VEGF) agents. Those eyes receiving prior anti-VEGF treatment received an average of 5.3 injections before ILUVIEN was administered, reflective of the current clinical practice and standard of care in the U.K. and Germany.
The use of corticosteroids is associated with accelerated development of cataract and elevated intraocular pressure (IOP). In these cases, the introduction of IOP lowering medication was required in two eyes (7%) compared with 38% in the FAME™ Study, Alimera's pivotal phase 3 study.
"Real world data on the use of ILUVIEN in the U.K. and Germany, as collected in this series of cases, have shown efficacy equivalent to that seen in the FAME Study," said Fahd Quhill, author of the paper. "In the limited number of cases reported in the public domain, the number of patients experiencing an elevation in IOP are fewer than reported in the FAME Study."
"We are pleased that ILUVIEN continues to show such positive results in Europe, as demonstrated in these cases," said Dan Myers, Alimera's president and chief executive officer. "It is both exciting and encouraging to see patients enjoy significantly improved vision and reduced retinal edema after receiving ILUVIEN."