Alimera Sciences, Inc., (NASDAQ: ALIM) (Alimera), a pharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, announced that Alimera Sciences Limited, its European subsidiary based in London, revealed interim six-month data on ILUVIEN® (Fluocinolone Acetonide 190 micrograms intravitreal implant in applicator) from the ongoing study referred to as RESPOND, a non-Randomised, open-label, multicenter phase 4 pilot study on the Effect and Safety of ILUVIEN® Fluocinolone Acetonide in chronic diabetic macular edema Patients cOnsidered iNsufficiently responsive to available therapies with or without intravitreal corticosteroiD therapy. The study is focused on the efficacy and safety of ILUVIEN, the first sustained release pharmaceutical product for the treatment of vision impairment associated with chronic diabetic macular edema (DME), considered insufficiently responsive to available therapies. The study data were presented at the 15th EURETINA Congress in Nice, France on September 17, 2015.
RESPOND is sponsored by AIBILI (Association for Innovation and Biomedical Research on Light and Image), funded by Alimera Sciences Limited, and is being conducted at four sites in Portugal. RESPOND enrolled 12 patients with chronic DME that did not respond sufficiently to previous treatments, laser and/or anti-vascular endothelial growth factor agents with or without corticosteroids. Each received a single injection of ILUVIEN (190 micrograms intravitreal implant in applicator) and will be followed for 12 months to gauge the effectiveness of the drug to improve visual acuity and reduce retinal thickness. The study will also closely monitor safety variables, such as a rise in intraocular pressure (IOP) and cataract progression.
The interim 6-month results showed that ILUVIEN was well tolerated and effective in reducing retinal thickness and increasing visual acuity. Of 11 patients completing their six-month visit, nine (82%) maintained or improved their Best Corrected Visual Acuity (BCVA) from baseline and 10 patients (91%) experienced a decrease in central subfield thickness (CST). The 11 patients with six months of follow up gained an average of 7.1 letters in BCVA from baseline and experienced an average decrease in CST of 300.6 microns from baseline.
"From clinical practice, we now understand that ILUVIEN provides a confirmed, sustained and fast efficacy with less safety concerns than initially presumed," said Dr. Joao Figueira, RESPOND coordinating investigator and principal investigator for the Center for Clinical Trials at AIBILI in Portugal.
"It is gratifying that ILUVIEN continues to show excellent results both in phase 4 clinical studies and in European physician's practices in patients who were considered insufficiently responsive to other treatments," said Dan Myers, president and chief executive officer, Alimera Sciences. "These early results are consistent with our belief that ILUVIEN would perform as well in clinical practice as was experienced in the FAME Study. We are pleased to work with the AIBILI team as they continue to follow the RESPOND patients, and we look forward to the 12-month results."
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