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20-Jun-2019

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

Aldershot, UK, June 2019 – The National Institute for Health and Care Excellence (NICE) has recommended ILUVIEN® (190µg fluocinolone acetonide (FAc) intravitreal implant in applicator) as an option for preventing relapse in recurrent non-infectious uveitis affecting the posterior segment of the eye (NIU-PS) in adults.1

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

NICE’s decision means there is now a treatment option that prevents uveitis recurrence for up to 3 years in a third (34.5%) of eyes3 and for up to 6 months in more than two thirds (72.4%) of eyes.4 ILUVIEN® also allows for direct dosage of steroid to the retina, minimising the side effects associated with systemic steroids whilst also preventing the need for the repeated injections required with local treatments.5,6

Following publication of its Final Appraisal Document, NICE requires that clinical commissioning groups, NHS England, and local authorities comply with its recommendation on ILUVIEN® within 3 months and within 2 months for NHS Wales.

Mr Carlos Pavesio, Specialist Uveitis Consultant Ophthalmologist at Moorfields Eye Hospital, said: “It is welcome news that there is now a long-acting intravitreal steroid available on the NHS for preventing relapse in patients with NIU-PS, as this is a treatment priority for this condition. Preventing vision loss due to relapse has a huge impact on patients’ quality of life.”

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 NICE decision to approve the Iluvien steroid implant for posterior uveitis. 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, presented at The Association for Research in Vision and Ophthalmology (ARVO) annual conference in April 2019, 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.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).4 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.4

"Birdshot Uveitis Society and our members are delighted that NICE 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

Helena Spooner:                                                  Lewis Picton:

hspooner@saycomms.co.uk                                  lpicton@saycomms.co.uk

020 8971 6429                                                       020 8971 6419

 

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 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.

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. National Institute for Health and Care Excellence (NICE). Fluocinolone acetonide intravitreal implant for treating recurrent non-infectious uveitis. Final appraisal document. Issued June 2019. Available from: https://www.nice.org.uk/guidance
  2. Yeh S., Shantha JG., The burden of noninfectious uveitis of the posterior segment: a review. Retina Today 2016; July/August: 47-51.
  3. Jaffe GJ. Treatment of non-infectious uveitis that affected the posterior segment with a single intravitreal Fluocinolone Acetonide Insert (Fai) – 3-Year results. Oral presentation given at The Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting. Vancouver, British Columbia, Canada, 28 April-2 May 2019
  4. ILUVIEN 190 micrograms intravitreal implant in applicator. Smpc information. https://www.medicines.org.uk/emc/product/3061 Last updated 28 March 2019. Accessed May 2019.
  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.

Date of preparation: June 2019                                                           Document number: UK-ILV-MMM-1458      

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

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Last Updated: 25-Jun-2019