Alimera Sciences, Inc., a biopharmaceutical company, announced that in its Final Appraisal Determination, the United Kingdom's National Institute for Health and Care Excellence (NICE) has recommended Iluvien funding for the treatment of pseudophakic eyes in chronic diabetic macular edema (DME) patients that are insufficiently responsive to available therapies.
The final draft guidance reverses the published guidance issued by NICE on January 23, 2013, and takes into consideration a simple patient access scheme submitted by Alimera. In addition, NICE reviewed Alimera's updated data analysis showing Iluvien's cost effectiveness among a subgroup of chronic DME patients who have an eye that is considered pseudophakic, meaning that the eye has already undergone cataract surgery.
"I am very pleased that my chronic DME patients will soon have access through the National Health Service (NHS) to Iluvien as a treatment option," said Moin Mohamed, consultant ophthalmic surgeon, Guy's and St Thomas' Hospital NHS Foundation Trust, London. "Vision is precious and a major contributor to a patient's overall quality of life. This recommendation from NICE gives chronic pseudophakic DME patients, who have exhausted all other treatment options, renewed hope. Ultimately, I would like to see Iluvien made available to all people with chronic DME."
Iluvien, a sustained release intravitreal implant, has received marketing authorization in the UK, Austria, Portugal, Germany, France and Spain, and is pending in Italy. Iluvien is currently commercially available in the UK and Germany.
"The NICE recommendation is a welcome development for chronic DME patients across England and Wales," said Robin Hamilton, consultant ophthalmic surgeon, Moorfields Eye Hospital NHS Foundation Trust, London. "With this determination, these patients will have access through NHS to a long-term, sustained release option for achieving improved visual acuity. Iluvien can have a significantly positive impact on their lives."
"This is excellent news for Alimera, as this positive recommendation from NICE will require the National Health Service (NHS) to make funding available for Iluvien in England and Wales. We plan to continue to work with NICE in an effort 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.
NICE's final guidance regarding reimbursement of Iluvien within the NHS in England and Wales is expected to be published in November 2013.
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 the FAME Study, the most frequently reported adverse drug reactions included cataract development and increased ocular pressure.
Alimera Sciences, Inc. specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals.