Real-world data on a fluocinolone acetonide intravitreal implant show sustained benefits of switching to the treatment in pseudophakic eyes that are insufficiently responsive to other therapies.
By Dr Clare Bailey
A 0.2 μg/day dose of a fluocinolone acetonide (FAc) intravitreal implant (Iluvien, Alimera Sciences) can be used in the treatment of vision impairment associated with chronic diabetic macular oedema (DMO) considered insufficiently responsive to available therapies1 and is approved by the National Institute for health and Care Excellence (NICE) in the United Kingdom for use in pseudophakic eyes.2
The latest data from real-life UK clinical practice show that the drug is a useful treatment option for DMO, offering visual benefits in this group of patients.3
Since the pivotal FAc Phase III clinical trials (FAME) were conducted in 2005-2011, the management of patients with chronic DMO has changed significantly. First-line treatment was traditionally focal laser photocoagulation, but this rarely resulted in an improvement in visual acuity.
Intravitreal vascular endothelial growth factor (VEGF) inhibitors are now the most widely used first-line option, and in the UK, NICE has approved their use for eyes with a central macular thickness of more than 400 μm.4,5 Monthly treatments are indicated initially, until the fluid no longer improves. The disadvantage of the VEGF treatment regimens is that numerous patient visits are required. Moreover, not all patients respond to anti-VEGF treatment.
In the Phase III clinical trials, the FAc implant was shown to be efficacious in the treatment of DMO, with benefits lasting for up to 36 months.6 The implant has a long-term microdose delivery system, which shows it has the potential to reduce the burden of managing the condition on the patient and health service, while improving visual outcomes.3,7
All patients included, however, had prior laser therapy and very few had received anti-VEGF therapies, whereas in real-world clinical practice the FAc implant is usually not considered until previous anti-VEGF treatments have failed to deliver a sufficient response. It was unclear, therefore, how it would perform outside of a clinical trial in real-world practice.
Using an electronic medical record data system (Medisoft), data has now been collected on real-world clinical treatment of chronic DMO for up to 24 months after patients have received a single FAc implant. These data, collected from 14 UK centres, show that 18.1% of treated eyes had 6/12 vision at baseline, rising to 39.6% at 24 months.3 86.7% of patients maintained or gained vision 24 months after receiving the implant, and 15% of patients achieved a ≥15 letter improvement at 12 months, which increased to 20.8% at 24 months.3
These efficacy findings confirm that the FAc implant is a useful treatment option for chronic DMO, even in patients who had a long duration of DMO and had received numerous prior DMO therapies. Additionally, they show a favourable safety profile with a similar frequency of intraocular pressure-related emergent adverse events to the Phase III trials.3
The key difference with the FAc implant over other DMO treatment options is the duration of action. In the Phase III trials, the FAc implant was shown to deliver visual benefits for up to 3 years, and current results show clinical practice achieves similar outcomes for up to 24 months.7 The Medisoft audit will continue to run in order to demonstrate whether results continue to be consistent with the clinical trials up to 36 months.
This real-world data has helped to build the evidence to show the sustained benefits of switching to the FAc implant in pseudophakic eyes that are insufficiently responsive to other therapies. The long duration of action of the product can also help to reduce the burden of treatments on the patient and health service.
1. Iluvien, Summary of Product Characteristics.
2. National Institute for Health and Care Excellence. Fluocinolone acetonide intravitreal implant for treating chronic diabetic macular oedema after an inadequate response to prior therapy (rapid review of technology appraisal guidance 271). NICE technology appraisal guidance 301, 2013. Available at: www.nice.org.uk/guidance/ta301. [Accessed October 2017]
3. Bailey C, et al. Real-world experience with 0.2μg/day fluocinolone acetonide intravitreal implant (ILUVIEN) in the United Kingdom. Eye. 21st July 2017. [Epub ahead of print]. Available at: http://www.nature.com/eye/journal/vaop/ncurrent/full/eye2017125a.html?foxtrotcallback=true
4. National Institute for Health and Care Excellence. Aflibercept for treating diabetic macular oedema. Technology appraisal guidance [TA346], 2015. Available at: https://www.nice.org.uk/guidance/ta346/chapter/1-Guidance [Accessed October 2017]
5. National Institute for Health and Care Excellence. Ranibizumab for treating diabetic macular oedema. Technology appraisal guidance [TA274], 2013. Available at: https://www.nice.org.uk/guidance/ta274/chapter/1-Guidance
6. Campochiaro PA, et al. Sustained delivery fluocinolone acetonide vitreous inserts provide benefit for at least 3 years in patients with diabetic macular edema. Ophthalmology. 2012;119:2125-2132.
7. Quhill F, Beiderbeck A. Cost advantage of fluocinolone acetonide implant (ILUVIEN) versus ranibizumab in the treatment of chronic diabetic macular oedema. Global & Regional Health Technology Assessment. 2017;4(1):e155-e164.
Dr Clare Bailey, MD FRCP FRCOphth
Dr Bailey is a consultant ophthalmologist at Bristol Eye Hospital, specialising in retinal disorders. She has been the clinical director of the retinal treatment and research unit since 2012, undertaking clinical research into retinal disorders, particularly age-related macular degeneration, diabetic retinopathy and retinal vein occlusion. She is the NIHR West of England lead for ophthalmology.
Dr Bailey participates in occasional advisory board meetings for Bayer, Novartis, Alimera Sciences, Roche and Allergan. Bristol Eye Hospital has undertaken clinical research funded by Bayer, Allergan, Roche, Novartis and Alimera Sciences.