The UK National Institute for Health and Care Excellence issues Final Guidance TA 953 recommending fluocinolone acetonide intravitreal implant for the treatment of visual impairment caused by chronic diabetic macular oedema, irrespective of the type of lens

NICE Final Guidance TA 953 recommends providing NHS patients with a phakic lens or pseudophakic lens, considered insufficiently responsive to available therapies with access to the only sustained-release treatment for chronic diabetic macular oedema lasting up to 36 months.

Alimera Sciences, Inc. (Nasdaq: ALIM) (“Alimera”), a global pharmaceutical company whose mission is to be invaluable to patients, physicians and partners concerned with retinal health and maintaining better vision longer announces that the National Institute for Health and Care Excellence (NICE) has issued Final Guidance TA 953 recommending that patients being treated for chronic diabetic macular oedema (DMO) regardless of their lens status have access to ILUVIEN 190 micrograms intravitreal implant in applicator (fluocinolone acetonide).

Mrs Christina Rennie, Consultant Ophthalmologist and Clinical Director of Patient Safety at University Hospital Southampton commented. 

‘I am pleased to see the extension of the NICE guidance to include phakic patients. This means that patients with diabetic macula oedema who are insufficiently responsive to other treatments, or for whom anti-VEGF injection is contra-indicated, now have another treatment option to help them improve vision. With its long duration of action, ILUVIEN brings stability for up to three years with a reduced treatment burden.’ 

NICE is recommending the implant as an option for treating visual impairment caused by chronic DMO in eyes with an artificial lens (pseudophakic) or with a natural lens (phakic) if their condition has not responded well enough to available treatments.

The new Guidance merges the outcome of a review of NICE technology appraisal guidance on fluocinolone acetonide intravitreal implant for treating chronic diabetic macular oedema in phakic eyes after an inadequate response to previous therapy (TA613) with the recommendation from NICE technology appraisal guidance on fluocinolone acetonide intravitreal implant for treating chronic diabetic macular oedema after an inadequate response to prior therapy in people with a pseudophakic (artificial) lens (TA301).

This means that with NICE Final Guidance TA 953, ILUVIEN can be prescribed in line with its marketing authorization indication for ‘the treatment of vision impairment associated with chronic diabetic macular oedema (DMO) considered insufficiently responsive to available therapies.

Philip Ashman, President International Operations at Alimera Sciences, said.

“We are delighted with the news that NICE has extended the recommendation for ILUVIEN to include phakic eyes affected by diabetic macular oedema. Up to now, options for such patients who are insufficiently responsive to anti-VEGF treatment have been very limited. We are confident that Ophthalmologists across England and Wales will welcome this news and the opportunity to improve vision for their patients, treating them for longer with fewer injections.”

About ILUVIEN

www.ILUVIEN.com

The Company’s primary product is ILUVIEN (fluocinolone acetonide intravitreal implant) 0.19 mg sustained release intravitreal implant, injected into the back of the eye. With its CONTINUOUS MICRODOSING™ technology, ILUVIEN is designed to release sub-microgram levels of fluocinolone acetonide, a corticosteroid, for 36 months, to reduce the recurrence of disease, enabling patients to maintain vision longer with fewer injections. ILUVIEN is approved in the U.S., Kuwait, Lebanon and the U.A.E to treat diabetic macular edema (DME) in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure. In 17 European countries, ILUVIEN is indicated for the treatment of vision impairment associated with chronic DME considered insufficiently responsive to available therapies. In March 2019, ILUVIEN received approval in the 17 countries under the Mutual Recognition Procedure for prevention of relapse in recurrent non-infectious uveitis affecting the posterior segment of the eye. The 17 European countries include the U.K., Germany, France, Italy, Spain, Portugal, Ireland, Austria, Belgium, Denmark, Norway, Finland, Sweden, Poland, Czechia, the Netherlands, and Luxembourg. ILUVIEN is marketed for the non-infectious posterior uveitis indication in Germany, France, the U.K., the Netherlands, Portugal, Spain, Austria, Ireland and Italy. ILUVIEN is not approved for treatment of uveitis in the United States.

About Diabetic Macular Oedema (DMO)

DMO, the primary cause of vision loss associated with diabetic retinopathy, is a disease affecting the macula, the part of the retina responsible for central vision. When the blood vessel leakage associated with diabetic retinopathy results in swelling of the macula, the condition is called DMO. The onset of DMO is painless and may go unreported by the patient until it manifests with the blurring of central vision or acute vision loss. The severity of this blurring may range from mild to profound loss of vision. The Wisconsin Epidemiologic Study of Diabetic Retinopathy found that over a 10-year period approximately 19% of people with diabetes included in the study were diagnosed with DMO. All people with type 1 or type 2 diabetes are at risk of developing DMO.

About Alimera Sciences, Inc.

www.alimerasciences.com

Alimera Sciences is a global pharmaceutical company whose mission is to be invaluable to patients, physicians and partners concerned with retinal health and maintaining better vision longer.  For more information, please visit www.alimerasciences.com.

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