pSivida Corp. (NASDAQ: PSDV) (ASX:PVA), a leader in developing sustained release, drug delivery products for treatment of back-of-the-eye diseases, announced today that the United Kingdom’s National Institute for Health and Clinical Excellence (NICE) has accepted for review additional data relating to the pseudophakic subgroup of patients with chronic diabetic macular edema (DME), meaning those patients who already had cataract surgery and had received an artificial lens when they entered the FAME™ Study conducted by pSivida’s licensee, Alimera Sciences, Inc. (Alimera). NICE is currently evaluating the cost-effectiveness of ILUVIEN for the treatment of chronic DME considered insufficiently responsive to available therapies.
Alimera reported that the additional data was included in an appendix to its comments on the preliminary Appraisal Consultation Document (ACD) of NICE’s Appraisal Committee issued in August for the ILUVIEN Single Technology Appraisal (STA). Alimera reported that according to NICE’s Guide to the STA, new data are only accepted if they are likely to affect the provisional recommendations in the ACD. In the provisional recommendations published in August, NICE proposed not to recommend the use of ILUVIEN to the U.K. National Health Service.
Alimera said that the Second Appraisal Committee meeting, previously scheduled for September 11, 2012, was rescheduled to October 11, 2012 because NICE informed Alimera that the Appraisal Committee required adequate time to thoroughly review the additional data.
Alimera reported that it determined that ILUVIEN was more cost-effective in the pseudophakic patient subgroup of the FAME Study. Because patients with artificial lenses cannot develop another cataract in the treated eyes due to their exposure to the corticosteroid delivered via ILUVIEN, they 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.