Alimera Sciences, Inc. (Alimera), a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, announced that the Appraisal Committee of the United Kingdom's National Institute for Health and Care Excellence (NICE) has issued a positive Appraisal Consultation Document (ACD) on Iluvien for the treatment of pseudophakic patients with chronic diabetic macular edema (DME) considered insufficiently responsive to available therapies. The ACD recommends a change to the published guidance issued by NICE on January 29, 2013, and takes into consideration a simple patient access scheme (PAS) that was submitted by Alimera for rapid review.
The NICE Appraisal Committee has reconfirmed Iluvien's clinical effectiveness in the treatment of vision impairment associated with chronic DME considered insufficiently responsive to available therapies. In the ACD, the Appraisal Committee reiterated "that the technology had been shown to meet a clinical need in people whose disease is unresponsive to available therapies."
Additionally, the committee noted that, based on the PAS, the cost-effectiveness threshold has been met for a subgroup of chronic DME patients who are pseudophakic, or have already undergone cataract replacement surgery.
"I am delighted that the Appraisal Committee has reconsidered the NICE guidance on Iluvien," said Winfried Amoaku, an associate professor and consultant ophthalmologist with Nottingham University Hospitals NHS Trust. "Chronic DME patients who are pseudophakic are now one step closer to receiving this crucial sight-saving treatment from the National Health Service. We cannot put a price on eyesight. Anything we can do to treat or prevent vision loss is essential. I welcome the Appraisal Committee's recommendation on the pseudophakic subgroup. It is hoped that NICE will update its recommendation in the fullness of time to allow access for a wider population of people with chronic DME."
"We are pleased with the Appraisal Committee's recommendation to provide access to Iluvien for pseudophakic DME patients, which is an important step in making this treatment available. We are optimistic that this ACD will lead to a change in the final published guidance. We believe that Iluvien is also effective in other groups of DME patients, and we plan to continue to work with NICE to broaden access to Iluvien to include all chronic DME patients who could benefit from the treatment," said Dan Myers, Alimera's president and chief executive officer.
Iluvien (190 micrograms intravitreal implant in applicator) is a sustained release intravitreal implant used to treat vision impairment associated with chronic DME considered insufficiently responsive to available therapies. Each Iluvien implant provides a therapeutic effect of up to 36 months by delivering sustained sub-microgram levels of fluocinolone acetonide (FAc). Iluvien is injected in the back of the patient's eye to a position that takes advantage of the eye's natural fluid dynamics. The applicator employs a 25-gauge needle, which allows for a self-sealing wound.
In July 2010, Alimera submitted a Marketing Authorization Application (MAA) to seven European countries via the Decentralized Procedure (DCP) with the Medicines and Healthcare products Regulatory Agency of the United Kingdom (MHRA) serving as the Reference Member State (RMS). The MAA included data from two phase 3 pivotal clinical trials (collectively known as the FAME Study) for Iluvien conducted by Alimera. The trials involved 956 patients in sites across the United States, Canada, Europe and India to assess the efficacy and safety of Iluvien for the treatment of DME. At the end of the DCP, a consensus was reached by the RMS and the other six countries that the MAA for Iluvien was approvable. To date, six of the seven countries, Austria, the United Kingdom, Portugal, France, Spain and Germany have granted national licenses for Iluvien. Iluvien has not been approved by the United States Food and Drug Administration.