Alimera Sciences announces change to SmPC allowing all United Kingdom (Great Britain and Northern Ireland) qualified ophthalmic healthcare professionals experienced in intravitreal injections to administer ILUVIEN®

15^th March 2025 – Alimera Sciences Limited, an ANI Pharmaceuticals, Inc. Company, today announced an update to the Summary of Product Characteristics (SmPC) for ILUVIEN 190 micrograms intravitreal implant in applicator (fluocinolone acetonide). The updated SmPC now allows all qualified ophthalmic healthcare professionals across the United Kingdom experienced in intravitreal injections to administer this treatment. Prior to this update, only ophthalmologists were authorised to inject ILUVIEN.

ILUVIEN, a sustained-release treatment lasting up to 36 months, is indicated for the treatment of vision impairment associated with chronic diabetic macular oedema (DMO) considered insufficiently responsive to available therapies as well as for the prevention of relapse in recurrent non-infectious uveitis affecting the posterior segment of the eye (NIU-PS).

The update aligns ILUVIEN with other intravitreal injections, which can be administered by qualified ophthalmic healthcare professionals such as nurses, optometrists and orthoptists. 

Mr. Peter Addison, Consultant Ophthalmic Surgeon and Deputy Director Uveitis & Scleritis Service at Moorfields Eye Hospital Foundation Trust, commented:

“Expanding the skill set of the nurse injectors in my clinic to include ILUVIEN has streamlined our workflow. Now that all four of our injectors are proficient in administering ILUVIEN, we can seamlessly incorporate these injections alongside other intravitreal injections (IVI), without the need to assign a specific injector to this task. This flexibility has improved efficiency and allowed us to better manage patient care.”

Alimera will provide all the training and support needed to ensure competence and confidence in delivering ILUVIEN as an intravitreal injection. Local Clinical Account Specialists can be contacted to arrange a training session for teams.

About ILUVIEN

www.ILUVIEN.co.uk

The Company’s primary product is ILUVIEN 190 micrograms intravitreal implant in applicator (fluocinolone acetonide), injected into the back of the eye. Together, chemistry and technology enable long-acting, continuous, low dose, steroid release with ILUVIEN for up to 36 months.^[1] ILUVIEN continuous microdosing results in zero order kinetics with stable steroid release for up to 3 years. Whilst most drugs are eliminated via first-order kinetics,[2] elimination with ILUVIEN is time rather than concentration dependent from approximately 6 months after administration.[3] In the UK ILUVIEN is approved for the treatment of vision impairment associated with chronic diabetic macular oedema considered insufficiently responsive to available therapies³ and for prevention of relapse in recurrent non-infectious uveitis affecting the posterior segment of the eye.³

About Diabetic Macular Oedema (DMO)

DMO, the primary cause of vision loss associated with diabetic retinopathy,[4] 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.[5] 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.[6] All people with type 1 or type 2 diabetes are at risk of developing DMO.

About Non-infectious uveitis affecting the posterior segment (NIU-PS)

Uveitis is inflammation in the middle layer of fibrous tissue enclosing the eye.[7] Uveitis in the posterior segment of the eye can lead to severe, irreversible vision loss and blindness.[8] Non-infectious uveitis of the posterior segment of the eye (NIU-PS) is often, but not always, linked to an autoimmune response or associated with a condition that causes an overreactive immune response.⁸

The symptoms associated with NIU-PS are often recurrent.⁷ Signs include a loss of visual acuity, increase of visual haze and increased thickness of the macula.[9] If left untreated, NIU-PS can cause other ocular conditions and complications, including glaucoma, cataract formation or macular oedema.[10]

About Alimera Sciences Limited, an ANI Pharmaceuticals, Inc. Company.

www.alimerasciences.co.uk

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.co.uk

For Press Enquiries:

[1] Habib MS. ILUVIEN® Technology in the Treatment of center-involving Diabetic Macular edema: a Review of the Literature. Ther Deliv 2018; 9: 547-556.

[2] Campochiaro PA, Brown DM, et al. Long-term benefit of sustained-delivery fluocinolone acetonide vitreous inserts for diabetic macular edema. Ophthalmology 2011; 118: 626-635.

[3] ILUVIEN, Summary of Product Characteristics.

[4] Chakravarthy U. Managing insufficiently responsive DMO patients. Post-NICE guidance. European Ophthalmic Review. Proceedings of a symposium presented at the Royal College of Ophthalmologists Annual Congress 2014 in Birmingham, UK 20-22^nd May 2014. 

[5] I Klaassen, Van Noorden CJ, Schlingemann RO. Molecular basis of the inner blood-retinal barrier and its breakdown in diabetic macular edema and other pathological conditions. Prog Retin Eye Res 2013; 34: 19–48. 

[6] Klein R, Klein BE, Moss SE, et al. The Wisconsin epidemiologic study of diabetic retinopathy. IV. Diabetic macular edema. Ophthalmology. 1984; 91(12): 1464-74.

[7] Barisani-Asenbauer T, Maca SM, Mejdoubi L, et al. Uveitis–a rare disease often associated with systemic diseases and infections–a systematic review of 2619 patients. Orphanet J Rare Dis. 2012; 7: 57.

[8] Yeh S., Shantha JG., The burden of noninfectious uveitis of the posterior segment: a review. Retina Today [Insert]. July/August 2016.

[9] Jaffe GJ., Pavesio C , et al. Effect of an injectable Fluocinolone Acetonide insert on recurrence rates in chronic non-infectious, intermediate, posterior, or Panuveitis: 3-year results. Ophthalmology. 2020; 127: 1395- 1404.

[10] Huang JJ., Elia M., Best Practice – Uveitis. British Medical Journal. 10 November 2017 [Accessed January 2025]. Available from:  https://bestpractice.bmj.com/topics/en-gb/407.