ATLANTA, Sept. 6, 2012 -- Alimera Sciences, Inc., (NASDAQ: ALIM) (Alimera), a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, today announced that the United Kingdom's National Institute for Health and Clinical Excellence (NICE) has accepted for consideration additional data in the form of an appendix to Alimera's comments on the preliminary Appraisal Consultation Document (ACD) previously issued by NICE for the ILUVIENSingle Technology Appraisal (STA).
NICE's Appraisal Committee, which issued the preliminary ACD in August, is currently evaluating the cost-effectiveness of ILUVIEN for the treatment of chronic diabetic macular edema (DME) considered insufficiently responsive to available therapies.
On September 4, 2012, NICE informed Alimera that the Appraisal Committee required adequate time to thoroughly review the additional data. Therefore, the Second Appraisal Committee meeting, previously scheduled for September 11, 2012, has been rescheduled for October 11, 2012. According to NICE's Guide to the STA, new data is only accepted if it is likely to affect the provisional recommendations in the ACD.
As Alimera was drafting its response to the ACD, the company determined that ILUVIEN was more cost-effective in a pseudophakic patient subgroup of Alimera's FAME Study, providing additional support to its ACD response submission.
As a result of diabetes, age or previous DME treatments, each patient in this subgroup had an artificial lens in his or her eye at the start of the study. Patients with an artificial lens cannot further develop a cataract in the treated eye due to their exposure to the corticosteroid delivered via ILUVIEN. These patients will not experience the transient reduction in visual acuity as the result of cataract development that occurred in some patients during the first two years of the FAME Study, nor will they incur the cost associated with cataract surgery.
"We remain hopeful that NICE will recognize ILUVIEN as a cost-effective therapy for all patients diagnosed with chronic DME who are insufficiently responsive to currently available therapies. The NICE Appraisal Committee's acceptance of our appendix submission presents the possibility of earlier patient access for patients with limited therapeutic options within the United Kingdom," said Dan Myers, president and chief executive officer, Alimera Sciences. "We look forward to NICE's review of this subgroup data, and we will continue to work closely with NICE in an effort to make this valuable treatment option available to patients in the United Kingdom as soon as possible."
PR Newswire