Sustained Delivery Fluocinolone Acetonide Vitreous Inserts Provide Benefit for at Least 3 Years in Patients with Diabetic Macular Edema

Long-Term Outcome of Approved Pharmacotherapy for Diabetic Macular Edema: A Review of Randomized Controlled Trials in Fluocinolone Acetonide Implants, Dexamethasone Implants, Aflibercept and Ranibizumab

“…Cataract requiring surgery happened in 74.9%, 84.5%, and 23.1% of the lowdose, high-dose, and sham groups. At three-year outcome, the visual gain remained stable and significant better in two different dosing treatment groups (+5.3 letters) than in the sham injections (+2 letters) [14]. But more adverse reactions were reported: nearly all treated phakic patients developed cataract; the incidence of incisional glaucoma surgery increased to 4.8% in the low-dose group and 8.1% in the high-dose group.…”

“…Intravitreal injections of anti-VEGF, including ranibizumab [2][3][4][5][6][7][8], bevacizuamb [9], pegaptanib [10], aflibercept [11] are proven to be effective for managing DME. Intravitreal injections of corticosteroids, potent anti-inflammatory agents, such as fluocinolone acetonide implants (Retisert) [12], fluocinolone acetonide inserts (Iluvein) [13,14], dexamethasone implants [15,16], and triamcinolone acetonide [2] have been shown to be beneficial to DME. The Food and Drug Administration of US and European Medicines Agency have approved intravitreal injections of fluocinolone acetonide inserts (Iluvein), dexamethasone implants, aflibercept, and ranibizumab for treating DME.…”

“…The insert is nonbiodegradable, which can be delivered into the vitreous cavity through a 25-gauge needle. Iluvein showed an anti-edematous effect persisting as long as three years after single injection [14]. The FAME study collected subjects with persistent DME despite at least 1 macular laser treatment.…”

Diabetic macular oedema: pathophysiology, management challenges and treatment resistance

“…Chronic DMO may also be more likely to be driven by inflammatory cytokines. In the long-term follow-up of the FAME study, eyes with DMO for longer than 3 years had superior visual outcomes to those with a shorter history [61]. Switching therapy from anti-VEGF agents, which may be more efficacious earlier in the natural history of DMO, to steroid therapy follows this rationale.…”

“…The Fluocinolone Acetonide for Macular Edema (FAME) study (ClinicalTrials.gov: NCT00344968) was a randomised trial of 953 eyes that compared 0.2 or 0.5 μg/day Iluvien implants delivered via an intravitreal injection with sham injections [61]. After 24 months, eyes gained an average of 4.4 and 5.4 letters in the low-and high-dose fluocinolone groups, respectively, compared with 1.7 letters in the sham group.…”