ILUVIEN APPROVED FOR A SECOND INDICATION

What does this mean for you, your
office, and your patients?

Find out

ILUVIEN APPROVED FOR A
SECOND INDICATION

What does this mean for you, your
office, and your patients?

Find out

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Reference

  1. ILUVIEN. Prescribing information. Alimera Sciences, Inc.

References

  1. 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(10):2125-2132.
  2. Campochiaro PA et al. for the FAMOUS Study Group. Aqueous Levels of FAc after Administration of FAc Inserts or FAc Implants. Ophthalmology 2013; 120:583-587.
  3. Kane F and Green K. Ocular Pharmacokinetics of Fluocinolone Acetonide Following ILUVIEN Implantation in the Vitreous Humor of Rabbits. J Ocul Pharmacol Ther. 2015; 31 (1):11-16.
  4. Merrill PT, et al. The 0.19-mg Fluocinolone Acetonide Intravitreal Implant Reduces Treatment Burden in Diabetic Macular Edema. Am J Ophthalmol. 2023;248:16-23.

References

  1. Campochiaro PA, et al. Ophthalmol. 2013;120:583-587.
  2. Romera-Aroca et al. Journal of Diabetes Research. 2016;2016:2156273.
  3. Rübsam et al. International Journal of Molecular Sciences. 2018;19(4):942.
  4. Merrill PT, et al. The 0.19-mg Fluocinolone Acetonide Intravitreal Implant Reduces Treatment Burden in Diabetic Macular Edema. Am J Ophthalmol. 2023;248:16-23.
  5. Data on file. Alimera Sciences, Inc. MI-DOF-064

Reference

  1. ILUVIEN® (fluocinolone acetonide intravitreal implant) 0.19 mg full US Prescribing Information. Alimera Sciences, Inc. 

Phakic Eyes

Consider ILUVIEN for phakic patients with DME, particularly those aged > 50 years and/or with developing cataracts

Patients with diabetes are 2 to 5 times more prone to cataract development2

In the ILUVIEN Phase 3 clinical trials:

  • 92% of patients were aged > 50 years3,4
  • 65% of all patients were phakic5
  • 83% of phakic patients had evidence of some cataract at baseline3
  • After cataract extraction, phakic patients treated with ILUVIEN had long-term VA outcomes similar to those observed in pseudophakic patients in the Phase 3 clinical trials6

References

  1. ILUVIEN® [package insert]. Alpharetta, GA: Alimera Sciences, Inc.
  2. Javadi MA, Zari-Ghanavati S. Cataracts in diabetic patients: A review article. J Ophthalmic Vis Rec. 2008;3(1):52-65.
  3. Data on file. Alimera Sciences, Inc.
  4. Mordi JA, Ciuffreda KJ. Statis aspects of accommodation: age and presbyopia. Vision Res. 1998;38:1643-1653.

Vitrectomized Eyes

Observations from a small, real-world cohort of vitrectomized patients with DME treated with ILUVIEN

  • In this retrospective study of 26 vitrectomized eyes treated with ILUVIEN, visual acuity and retinal thickness improved (mean follow-up 8.5 months)1
  • 31% of patients had increases in intraocular pressure (IOP) that were managed with drops; none required surgery at the time of study publication
  • 2 patients in this study experienced migration of the ILUVIEN implant to the anterior chamber. In both cases, there was a history of capsular tear and ILUVIEN was surgically repositioned without further complication
  • Patients in whom the posterior capsule of the lens is absent or has a tear are at risk of implant migration into the anterior chamber1

Reference

  1. Meireles A, Goldsmith C, El-Ghrably I, et al. Efficacy of 0.2 µg/day fluocinolone acetonide implant (ILUVIEN) in eyes with diabetic macular edema and prior vitrectomy. Eye (Lond). 2017;31(5):684-690.

References

  1. Singer MA, et al. Three-Safety and Efficacy of the 0.19-mg Fluocinolone Acetonide Intravitreal Implant for Diabetic Macular Edema: The PALADIN Study. Ophthalmology. 2022;129(6):605-613.
  2. Eaton A, et al. The USER Study: A Chart Review of Patients Receiving a 0.2 µg/day Fluocinolone Acetonide Implant for Diabetic Macular Edema. Ophthalmol Ther. 2019;8(1):51-62.
  3. Data on file. Alimera Sciences, Inc. MI-DOF-064.

Limitations of the USER Study

  • Data are based on clinical practice, where the reporting of data is not standardized, and the data may not be as rigorous as in a clinical trial where the data collected are monitored.
  • USER involved the collection of data up to 3 years prior to ILUVIEN (when available) and all available data post-ILUVIEN — Mean follow-up after ILUVIEN was 403 days, with 102 eyes followed up for 6 months, 92 for 12 months, and 50 for 18 months.
  • Optical coherence tomography (OCT) data were only available for 120 eyes.

Limitations of the Study

  • This is a small, retrospective study
  • Data were based on clinical practice, where there is reporting of non-standardized data, and the data may not be as rigorous as in a clinical trial where the data collection is monitored
  • The effect of the vitrectomy procedure on the duration of the intravitreal therapy is not fully understood
  • Further studies are required to confirm the current findings and assess the effect of ILUVIEN over a longer period of follow-up
  • The collection and reporting of this retrospective data with a relatively small number of patients and short period of follow-up post-therapy with ILUVIEN (mean = 8.5 months) should not be compared with the FAME pivotal studies, which provided 36 months of follow-up data
  • Study was performed in Europe, where clinical practice may be different. In Europe, ILUVIEN is approved for the treatment of visual impairment due to chronic DME considered insufficiently responsive to available therapies

Conflicts of Interest

Authors of this study received compensation from Alimera. Two authors received speaker honoraria from Alimera, and two authors were consultants. One author received reimbursement of travel expenses and study support from Alimera.

Studies Design: FAME

FAME A and B were randomized, double-masked, sham injection–controlled, parallel-group, multicenter studies conducted under a single protocol over 36 months.

Study arms:

561 subjects randomized 2:1

  • 0.2 μg/day FAc intravitreal insert
  • Sham injection

Primary endpoint:

Proportion of subjects with improvement in BCVA ≥ 15 letters at 24 months

Inclusion criteria:

Foveal thickness ≥ 250 μm despite ≥ 1 prior focal/grid macular laser photocoagulation treatments and BCVA in ETDRS letter score between 19 and 68 (20/50-20/400).

Exclusion criteria:

Glaucoma, ocular hypertension, IOP > 21 mm Hg, or using IOP-lowering drops.

Reference:

  • Campochiaro PA, Brown DM, Pearson A, et al. Sustained delivery fluocinolone acetonide vitreous inserts provide benefit for at least 3 years in patients with diabetic macular edema. Ophthalmology. 2012;119(10):2125-2132.

Reference

1. ILUVIEN® [package insert]. Alpharetta, GA: Alimera Sciences, Inc.

References

1. ILUVIEN® [package insert]. Alpharetta, GA: Alimera Sciences, Inc.

2. Parrish RK, Campochiaro PA, Pearson PA, Green K, Traverso CE, FAME Study Group. Characterization of intraocular pressure increases and management strategies following treatment with fluocinolone acetonide intravitreal implants in the FAME trials. Ophthalmic Surg Lasers Imaging Retina. 2016;47:426-435.

References

  1. 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(10):2125-2132.
  2. ILUVIEN® (fluocinolone acetonide intravitreal implant) 0.19 mg full US Prescribing Information. Alimera Sciences, Inc.

Reference

  1. ILUVIEN® (fluocinolone acetonide intravitreal implant) 0.19 mg full US Prescribing Information. Alimera Sciences, Inc. 

Reference

1. Meireles A, Goldsmith C, El-Ghrably I, et al. Efficacy of 0.2 µg/day fluocinolone acetonide implant (ILUVIEN) in eyes with diabetic macular edema and prior vitrectomy. Eye (Lond). 2017;31(5):684-690.

References

1. ILUVIEN® [package insert]. Alpharetta, GA: Alimera Sciences, Inc.

2. Javadi MA, Zari-Ghanavati S. Cataracts in diabetic patients: A review article. J Ophthalmic Vis Rec. 2008;3(1):52-65.

3. Data on file. Alimera Sciences, Inc.

4. Mordi JA, Ciuffreda KJ. Statis aspects of accommodation: age and presbyopia. Vision Res. 1998;38:1643-1653.

5. Campochiaro PA, Brown DM, Pearson A, et al. Long-term benefit of sustained-delivery fluocinolone acetonide vitreous inserts for diabetic macular edema. Ophthalmology. 2011;118:626-635.

6. Yang Y, Bailey C, Holz FG, et al. Long-term outcomes of phakic patients with diabetic macular oedema treated with intravitreal fluocinolone acetonide (FAc) implants. Eye (Lond). 2015;29:1173-1180.

Reference

1. Data on file. Alimera Sciences, Inc.

Reference

1. Data on file. Alimera Sciences, Inc.