Diabetic eye disease (DED) poses a significant health challenge due to its potential to cause significant visual loss. Due to population ageing and the rise in the number of patients with diabetes, all countries around the world are affectedCitation1. Approximately a quarter of those with diabetes develop diabetic macular edema (DME) within 10 years of diagnosisCitation2. The vast number of patients pose a significant financial and societal problem in treating DMECitation3. Neither focal/grid thermal laser photocoagulationCitation4 nor intravitreal anti-vascular endothelial growth factor (VEGF) therapy achieve the desired outcomes for all patientsCitation5,Citation6, although even patients with less than optimal response after these treatments do better than allowing the devastating natural history of the disease to take holdCitation7.
In those who do not respond well to laser therapy or anti-VEGF injections, intravitreal corticosteroid implants can be used. The reports in this issue of Current Medical Research and OpinionCitation8–11 show that the 0.2 μg/day fluocinolone acetonide (FAc) intravitreal implant (Iluvien1) was effective in treating DME for up to 12 monthsCitation12, a significant clinical outcome. Apart from this improvement, as corticosteroids’ biological activity is longer in duration than that of anti-VEGF, its administration allows for a less frequent injection regime, resulting in fewer clinic visits, fewer intravitreal procedures and, consequently, lower risk of endophthalmitisCitation11. The primary side-effects of treatment with the FAc implant were intraocular pressure (IOP) elevation and cataract formationCitation3, neither of which was unexpected.
Clearly, when treated with FAc implants, patients with chronic DME and poor vision benefited, an important point to take into consideration when treatment is rolled out to those who are yet to gain vision using the “classical” treatment modalitiesCitation8,Citation12. Those with the poorest visual acuity did well in the clinical setting, providing the clinician with an additional potential therapeutic option where none existed previously. Recipients of the FAc implant also required fewer anti-VEGF injections in the period after implantation, another important consideration with both clinical and financial implications. In addition, the severity of diabetic retinopathy was haltedCitation12, just as it was with anti-VEGFCitation5,Citation6.
Amongst the recorded clinical cases, neither cataract formation nor IOP rise proved to be as great an issue as might be expected based on findings from clinical trialsCitation8–12. The authors reported that most recipients were pseudophakic at the time of FAc implant, or they had cataract surgery at the time of implantation and therefore cataract formation was no longer a concern for most patientsCitation12. Whilst in clinical trials of FAc, IOP rise was recorded more frequently in the actively treated arm, once the drug was used in the clinical setting, most cases with elevated IOP could be managed with pressure-lowering drugs, and only in rare cases was surgery requiredCitation12. Patients responded well to treatment, and both the implant and the IOP-lowering procedures were well tolerated.
Overall, data from a real-life UK setting showed that patients benefited from the FAc treatment even if they had poor visual acuity at the time of implantation, that the limitation for pseudophakia was easily overcome and that IOP rise was not of major concern. These factors, coupled with the fact that the current reviews suggest significant cost savings, truly support the inclusion of the FAc implant into routine clinical practice.
Transparency
Declaration of funding
This editorial is part of a series of articles supported by Alimera Sciences, the manufacturer of Iluvien 190 µg intravitreal implant.
Declaration of financial/other relationships
T.P. has disclosed that she has no significant relationships with or financial interests in any commercial companies related to this study or article.
CMRO peer reviewers on this manuscript have received an honorarium from CMRO for their review work, but have no other relevant financial relationships to disclose.
Note
Notes
1 Iluvien is a registered trade name of Alimera Sciences Limited, Aldershot, UK
References
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- Currie CJ, Holden SE, Owens DR. Patterns of retinal thickness prior to and following treatment with fluocinolone acetonide 190 µg intravitreal implant for diabetic macular edema. Curr Med Res Opin 2017;33(Suppl):33-43
- Holden SE, Currie CJ, Owens DR. Health economic evaluation of fluocinolone acetonide 190 µg implant in people with diabetic macular edema. Curr Med Res Opin 2017;33(Suppl):45-52
- Bailey C, Chakravarthy U, Lotery A, et al.; Medisoft Audit Group. Real-world experience with 0.2 μg/day fluocinolone acetonide intravitreal implant (ILUVIEN) in the United Kingdom. Eye (Lond) 2017: published online 24 July 2017, doi: 10.1038/eye.2017.125