SMC accepts ILUVIEN® for prevention of relapse in recurrent non-infectious uveitis affecting the posterior segment of the eye

Aldershot, UK, September 2020 – The Scottish Medicines Consortium (SMC) has accepted ILUVIEN^® (190µg fluocinolone acetonide (FAc) intravitreal implant in applicator) for use within NHS Scotland for prevention of relapse in recurrent non-infectious uveitis affecting the posterior segment of the eye (NIU-PS) in adults.¹

NIU-PS is a sight threatening, inflammatory condition chiefly affecting people during prime working years.² The treatment of NIU-PS can present substantial challenges, and the unpredictability of uveitis recurrence can make it difficult for patients to plan any aspect of their lives.²

The SMC’s decision means there is now a treatment option available to patients in Scotland which greatly increases the time patients are free from the recurrence of uveitis (median 657 days recurrence-free for eyes treated with ILUVIEN^® compared with 70.5 days for eyes given treated control).⁴ Study data also shows that ILUVIEN^® prevents recurrence for up to 6 months in more than two thirds (72.4%) of eyes³ and for up to 3 years in a third (34.5%) of eyes.⁴ Additionally, patients treated with ILUVIEN^® required fewer adjunctive treatments (57.5%) compared to (97.6%) those receiving treated control.⁴

ILUVIEN^® delivers a continuous, sustained release of steroid at sub-microgram doses to the retina each day for up to 3 years, reducing ocular inflammation and minimising the side effects associated with systemic steroids, whilst also lowering the need for the repeated injections required with local treatments.^5,6

Following release of the SMC public notification, ILUVIEN^® will become funded and available immediately through the NHS to Scottish patients with recurrent NIU-PS.

Dr Mohan Varikkara Consultant Ophthalmologist at University Hospital Ayr who has treated patients with ILUVIEN^® says: “ILUVIEN becoming available for treatment of NIU-PS through the NHS in Scotland is incredibly welcome news. It is good to have a treatment option that can be directly delivered into the eye which helps keep inflammation down to non-sight threatening levels. It is a long acting implant which could potentially work for 3 years to prevent relapse and protect patients from further vision loss. The ILUVIEN implant can also reduce the need for systemic medications, minimising their associated side effects and decreasing the need for regular blood monitoring, thus reducing the burden for patients.”

Complications resulting from intraocular inflammation can damage the eye, so timely diagnosis and effective management of NIU-PS are imperative to avoid potentially severe vision loss.²

“Olivia’s Vision is delighted with the SMC decision to accept the ILUVIEN steroid implant for posterior uveitis – making it the first treatment approved for use on the NHS in Scotland to prevent relapse in the condition rather than just treating active disease. For patients whose uveitis is unresponsive to other treatments, or the side effects intolerable, ILUVIEN brings with it an effective, slow releasing steroid, improving sight as well as the quality of life for those affected by this sight threatening eye disease. Where steroid implant treatment is necessary, Olivia’s Vision looks forward to Iluvien becoming the staple,” said Nicki Davis, Charity Trustee at Olivia’s Vision

36-month data from the PSV-FAI-001 study showed that significantly more eyes treated with ILUVIEN^® experienced no recurrence* of uveitis over three years compared to those in the treated control group (34.5% of eyes treated with ILUVIEN^® versus 2.4% treated control).³

The secondary outcomes of the study showed that patients treated with ILUVIEN^® had a reduced need of adjunctive systemic or immunosuppressant treatments (34.5%) compared to (50%) those receiving treated control.⁴

The most common adverse events in eyes treated with ILUVIEN^® were increased intraocular pressure (IOP) and cataract formation.⁴ However, raised IOP was managed well in both study arms, primarily with the use of IOP-lowering medications (42.5% ILUVIEN^®, 33.3% treated control).³ At 36 months, cataract surgery had been performed in 73.8% of phakic eyes treated with ILUVIEN^® compared with 23.8% of treated control phakic eyes.³

"Birdshot Uveitis Society and our members are delighted that the SMC has approved the ILUVIEN implant for use in posterior uveitis patients. It is a very welcome development as this slow release steroid implant offers a very effective treatment directly targeting inflammation in the eye without a lot of the unpleasant side effects of more systemic drugs which have been frequently used in the past," said Annie Folkard, one of the founders of The Birdshot Uveitis Society

*Recurrence defined as an increase in both anterior chamber cells and vitreous haze, a reduction in visual acuity and imputed for requiring adjunctive treatment or missing data.

END

About 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.² Non-infectious uveitis of the posterior segment (NIU-PS) is often, but not always, linked to an autoimmune response or associated with a condition that causes an overreactive immune response.² The symptoms associated with NIU-PS are often recurrent.⁷ Signs include a loss of visual acuity, increased visual haze and increased thickness of the retina.⁸ If left untreated, NIU-PS can cause other ocular conditions and complications, including glaucoma, cataract formation or macular oedema.²

About ILUVIEN®

ILUVIEN^® (fluocinolone acetonide intravitreal implant in applicator) is a corticosteroid indicated for the treatment of vision impairment associated with chronic diabetic macular oedema (DMO), considered insufficiently responsive to available therapies, and for prevention of relapse in recurrent non-infectious uveitis affecting the posterior segment of the eye (NIU-PS). For DMO, ILUVIEN^® was granted market authorisations in 17 countries in Europe through the EU decentralised mutual recognition procedure in February 2012, and gained US FDA approval in 2014. It is commercially available in the United Kingdom, Ireland, Germany, Austria, Portugal, Italy, Spain, France, the Middle East and the United States.

For NIU-PS, ILUVIEN^® was granted approval on 22 March 2019 (UK) for prevention of relapse in recurrent non-infectious uveitis affecting the posterior segment of the eye through the European mutual recognition procedure in 17 member states in Europe by the Reference Member State (RMS), the UK Medicines and Healthcare products Regulatory Agency (MHRA). The regulatory process will now enter the national phase in which each member state grants its national license. ILUVIEN^®  was recommended by NICE for prevention of relapse in recurrent non-infectious uveitis affecting the posterior segment of the eye in June 2019.

Prescribing information can be found at https://www.medicines.org.uk/emc/product/3061  

More information relating to ILUVIEN^® can be found at https://www.iluvien.co.uk/

About Alimera Sciences

Alimera Sciences is a pharmaceutical company that specialises in the commercialisation and development of prescription ophthalmic pharmaceuticals and is dedicated to developing innovative, vision-improving treatments for diseases of the retina. The company was founded in June 2003 in Alpharetta, Georgia, USA. Alimera Sciences now operates directly in the United States, United Kingdom, Ireland, Germany, Austria and Portugal and through third party distribution agreements in Spain, Italy, France and The Middle East. The UK subsidiary, Alimera Sciences Limited, was launched in 2013. The European offices are situated in Aldershot, Hampshire, UK.

References:

1. https://www.scottishmedicines.org.uk/medicines-advice/fluocinolone-acetonide-iluvien-full-smc2260/
2. Yeh S., Shantha JG., The burden of noninfectious uveitis of the posterior segment: a review. Retina Today 2016; July/August: 47-51.
3. ILUVIEN 190 micrograms intravitreal implant in applicator. Smpc information. https://www.medicines.org.uk/emc/product/3061 Last updated 28 March 2019. Accessed August 2019.
4. Jaffe GJ, Pavesio CE; Study Investigators. Effect of a fluocinolone acetonide insert on recurrence rates in noninfectious intermediate, posterior, or panuveitis: Three-year results. Ophthalmology. 2020 [article in press].
5. Jaffe GJ, Foster S, et al. Effect of an injectable Fluocinolone Acetonide insert on recurrence rates in chronic non-infectious uveitis affecting the posterior segment (12-month results). American Academy of Ophthalmology. 2016. ISSN 0161-6420/16.
6. Larson T, Nussenblatt RB, Sen HN, et al. "Emerging drugs for uveitis". Expert Opinion on Emerging Drugs. June 2011;16(2): 309–22.
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. Jaffe GJ., Lin P., Keenan RT., et al. Effect of an injectable Fluocinolone Acetonide insert on recurrence rates in chronic non-infectious uveitis affecting the posterior segment (Two-year results). American Academy of Ophthalmology. 2018. ISSN 0161-6420/18.