Fluocinolone acetonide implant in diabetic macular edema: International experts' panel consensus guidelines and treatment algorithm.

Center-involving diabetic macular edema (DME) is a leading cause of vision impairment in working-age adults. While its management is particularly challenging in a poorly compliant population, continuous innovation and the advent of new molecules have improved its outcome. The control of glycemia and of systemic aggravating factors remain essential to slow down progression of disease complications including DME. The indications for macular laser photocoagulation has progressively been phased out as a standard of care and replaced by local intraocular anti-VEGFs biologics and glucocorticoids (GCs). Intravitreal GCs in controlled-release drug delivery systems have allowed to reduce injection frequency and treatment burden. The non biodegradable Fluocinolone Acetonide (FAc) implant allows a long-lasting stabilization of both functional and anatomic improvements. However, adequate patient selection and monitoring through regular follow-up are essential for optimal results. Based on their experience and the latest literature, the aim of the present review is to provide international expert panel consensus on the place of the FAc implant in the treatment algorithm of DME, as well as its safety profile and how to manage it.

Post-marketing surveillance study of the safety of dexamethasone intravitreal implant in patients with retinal vein occlusion or noninfectious posterior segment uveitis.

PURPOSE: To evaluate the long-term safety of dexamethasone intravitreal implant (DEX) in patients treated for macular edema associated with retinal vein occlusion (RVO) or noninfectious posterior segment uveitis (NIPSU) in clinical practice. PATIENTS AND METHODS: Multicenter (102 sites in France, Germany, Spain, UK), prospective, observational, post-authorization safety study in adult patients treated with DEX. Data collected up to 2 years after enrollment included serious adverse events (SAEs) and adverse events of special interest (AESIs; adverse drug reactions that are considered important risks associated with DEX and listed in the European Union Ozurdex Risk Management Plan). RESULTS: Overall, 803 patients (652 RVO, 151 NIPSU) received on-study DEX treatment, and 73.1% completed 24 months of follow-up; 72.6% were DEX-naïve. Median number of on-study injections per treated eye was 2 (range, 1-7); median reinjection interval was 27.1 weeks. Nonocular SAEs affected 9.5% of patients; none were considered DEX-related. Ocular SAEs (most common: cataract progression) occurred in 3.2% of treated eyes. SAEs were similar in eyes stratified by previous DEX use and number of on-study DEX injections (≤2 or >2), in both RVO and NIPSU. The most common AESIs were cataract formation and progression (20.0% and 19.2% of treated phakic eyes, n=551), increased intraocular pressure (19.0% of treated eyes), and vitreous hemorrhage (3.3% of treated eyes). Cataract progression was more frequent in baseline phakic eyes that were previously treated with DEX or received >2 on-study DEX injections. CONCLUSION: The long-term safety profile of DEX was acceptable. No new safety concerns were identified.