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

This site is intended for US healthcare professionals only

AccessPlus

Helping Patients Access the Treatment They Need

ILUVIEN AccessPlus Program offers patient reimbursement support services that can be integrated into your patient processing system.

Benefits Investigation

Reimbursement Support

Financial Assistance Resources

Product Acquisition Flexibility

Get an overview of the ILUVIEN AccessPlus program.

DOWNLOAD

The ILUVIEN AccessPlus program steps:

  1. Prescribing physician enrolls one time with a simple, one-page Prescriber Information Form.
  2. The Patient Enrollment Form collects information needed for coverage coordination (benefits investigation, prior authorization, product acquisition options, and financial assistance).
  3. The Prescribing Physician receives a Summary of Patient Benefits for each patient benefits investigation with detailed information on ILUVIEN coverage for your patient.

Alimera is committed to supporting your practice. Our Field Reimbursement Managers are available to partner with you as you navigate the ILUVIEN reimbursement process.

Phone: 1-844-445-8843, Option 3

  • AccessPlus Case Managers are available Monday – Friday, 8 AM – 8 PM EST
  • Fax: 1-844-501-7161

Download Prescriber Information Form

Download

Benefits Investigation

Let us help you determine your patients’ coverage for ILUVIEN

  • Complete Patient Enrollment Form to initiate benefits investigation
  • A Summary of Patient Benefits will be provided, typically within 48 hours
  • Prior authorization requirements with payer-specific processes and forms will be provided
  • Patient out-of-pocket responsibility and financial assistance options for ILUVIEN are available

Get the Patient Enrollment Form

English Download
Spanish Download

Reimbursement Support

Field Reimbursement Managers are dedicated to providing proactive reimbursement support to your practice for patient coverage scenarios, including:

  • Coding and billing guidance
  • Prior authorization assistance
  • Claims follow-up
  • Appeals support
  • Specialty pharmacy prescription referral routing and follow-up

Reimbursement support materials are available:

BILLING & CODING GUIDE

Download

Sample Letter of medical necessity

Download

Sample Letter of appeal

Download

Financial Assistance Resources

ILUVIEN offers programs to support patient access:  ILUVIEN CoPay and ILUVIEN Patient Assistance.

ILUVIEN CoPay Program

The ILUVIEN CoPay Program provides assistance toward product-specific copay, co-insurance and insurance deductibles for ILUVIEN that exceed $25.* Qualifying patients are responsible for a maximum of $25.00 out-of-pocket costs.

To help your patients with their out-of-pocket costs for ILUVIEN, the ILUVIEN CoPay Program is available for eligible patients who have commercial or private insurance.  There is no income eligibility requirement and no maximum assistance level. Eligibility requirements include:

  • Patient must have commercial or private insurance that covers ILUVIEN for the FDA-labeled indication
  • Patient out-of-pocket cost for ILUVIEN must exceed $25
  • Patient must provide household income and number in household
  • Patient must be a resident of the United States

*The program does not cover or provide support for procedures, supplies, or physician-related services associated with ILUVIEN. Only product-specific copay, co-insurance and insurance deductibles are covered. This program is not valid where prohibited by law, taxed or restricted. Alimera Sciences reserves the right to change or cancel this offer or eligibility terms at any time without notice.

Download the ILUVIEN CoPay Program Brochure

English Download
Spanish Download

ILUVIEN Patient Assistance Program

The ILUVIEN Patient Assistance Program provides ILUVIEN free of charge to eligible patients who are uninsured or lack coverage for ILUVIEN. Eligibility requirements include:

  • Uninsured or lack coverage for ILUVIEN
  • ILUVIEN must be prescribed per the FDA-labeled indication
  • Patient must be a resident of the United States
  • Patient must have a financial need
  • Based on total adjusted annual household income of $100,000 or less

The process:

    1. Fax the completed and signed PAP application to AccessPlus at 1-844-501-7161.
    2. The application will be reviewed, and an approval decision will be made within 5 business days.
    3. The provider office and the patient will receive a letter with the approval status of the application.
    4. AccessPlus will coordinate shipment of ILUVIEN to your office upon approval of the patient application.

Download the ILUVIEN Patient Assistance Program (PAP)

Download

Product Acquisition

There are a number of acquisition options for ILUVIEN. Choose the one that best suites your practice.

  • Distributors for the buy-and-bill process
    • Besse Medical Ophthalmology
    • McKesson Specialty Health
  • Specialty Pharmacy Network

To order ILUVIEN, contact today one of the distributors listed below.

Besse Medical Ophthalmology

1-888-767-7123 | View Besse online catalog | ILUVIEN Order No. 44083

McKesson Specialty Health

1-855-477-9800 | View McKesson’s Ophthalmology site | ILUVIEN Order No. 5004970

Veterans Administration Drug Acquisition: McKesson Plasma and Biologics LLC

Phone Orders: 1-877-625-2566 | Fax Orders: 1-888-752-7626 | Email:  mpborders@McKesson.com | Online: Connect.McKesson.com ILUVIEN Order No. 3428968

Department of Defense Drug Acquisition: DMS Pharmaceutical Group, Inc.

(Accessible through DoD web portal)

Consignment Replacement

See options here

IMPORTANT SAFETY INFORMATION AND INDICATION

IMPORTANT SAFETY INFORMATION

Contraindications

  • ILUVIEN is contraindicated in patients with active or suspected ocular or periocular infections including most viral diseases of the cornea and conjunctiva including active epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, mycobacterial infections and fungal diseases.
  • ILUVIEN is contraindicated in patients with glaucoma who have cup to disc ratios of greater than 0.8.
  • ILUVIEN is contraindicated in patients with known hypersensitivity to any components of this product.

Warnings and Precautions

  • Intravitreal Injection-related Effects: Intravitreal injections, including those with ILUVIEN, have been associated with endophthalmitis, eye inflammation, increased or decreased intraocular pressure, and choroidal or retinal detachments. Patients should be monitored following the intravitreal injection. Patients may experience temporary blurred vision after injection of the implant.
  • Intraocular Pressure (IOP) Increase: Prolonged use of corticosteroids may result in the development of glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision. Steroids should be used with caution in the presence of glaucoma. Intraocular pressure should be routinely monitored during the course of the treatment.
  • Cataracts: The use of corticosteroids may result in posterior subcapsular cataract formation.
  • Delayed Corneal Wound Healing: The use of corticosteroids after cataract surgery may delay healing and increase the incidence of bleb formation.
  • Corneal and Scleral Melting: Various ocular diseases and long-term use of topical corticosteroids have been known to cause corneal and scleral thinning. Use of ophthalmic corticosteroids in the presence of thin corneal or scleral tissue may lead to perforation of the globe.
  • Bacterial Infections: Prolonged use of corticosteroids may suppress the host response and thus increase the hazard of secondary ocular infections. Acute purulent or parasitic infections of the eye may be masked or activity enhanced by the presence of corticosteroid medication. If signs and symptoms fail to improve after 2 days, the patient should be reevaluated.
  • Viral Infections: Use of ocular corticosteroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex). Employment of a corticosteroid medication in the treatment of patients with a history of herpes simplex requires great caution; frequent slit lamp microscopy is recommended.
  • Fungal Infections: Fungal infections of the cornea are particularly prone to develop coincidentally with long-term local corticosteroid application. Fungus invasion should be suspected in any persistent corneal ulceration where a corticosteroid has been used or is in use. Fungal cultures should be taken when appropriate.
  • Risk of Implant Migration: Patients in whom the posterior capsule of the lens is absent or has a tear are at risk of implant migration into the anterior chamber.
  •  

Adverse Reactions

Diabetic Macular Edema
Ocular adverse reactions reported by greater than or equal to 1% of patients in the two combined 3-year clinical trials following injection of ILUVIEN for diabetic macular edema include: cataract (82%), myodesopsia (21%), eye pain (15%), conjunctival hemorrhage (13%), posterior capsule opacification (9%), eye irritation (8%), vitreous detachment (7%), conjunctivitis (4%), corneal oedema (4%), foreign body sensation in eyes (3%), eye pruritus (3%), ocular hyperaemia (3%), optic atrophy (2%), ocular discomfort (2%), photophobia (2%), retinal exudates (2%), anterior chamber cell (2%), and eye discharge (2%). Non-ocular adverse reactions reported by greater than or equal to 5% of patients include: anemia (11%), headache (9%), renal failure (9%), and pneumonia (7%)

Increased Intraocular Pressure: IOP elevation greater than or equal to 10 mm Hg from baseline at any visit was seen in 34% of ILUVIEN patients versus 10% of sham patients. IOP elevation greater than or equal to 30 mm Hg was seen in 20% of ILUVIEN patients versus 4% of sham patients. 38% of the patients who received ILUVIEN were subsequently treated with IOP-lowering medications during the study versus 14% of sham patients. 5% of the patients who received ILUVIEN needed surgical intervention for elevated IOP versus 1% of sham patients

Cataracts and Cataract Surgery: The incidence of cataract development in patients who had a phakic study eye was higher in the ILUVIEN group (82%) compared with sham (50%). The median time of cataract being reported as an adverse event was approximately 12 months in the ILUVIEN group and 19 months in the sham group. Among these patients, 80% of ILUVIEN subjects versus 27% of sham-controlled subjects underwent cataract surgery, generally within the first 18 months (median month 15 for both ILUVIEN group and for sham) of the studies.

INDICATION

ILUVIEN is a corticosteroid indicated for:

  • the treatment of diabetic macular edema (DME) in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure.

Please see full Prescribing Information.

IMPORTANT SAFETY INFORMATION

Contraindications

  • ILUVIEN is contraindicated in patients with active or suspected ocular or periocular infections including most viral disease of the cornea and conjunctiva including active epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, mycobacterial infections and fungal diseases.
  • ILUVIEN is contraindicated in patients with glaucoma who have cup to disc ratios of greater than 0.8.
  • ILUVIEN is contraindicated in patients with known hypersensitivity to any components of this product.

Warnings and Precautions

  • Intravitreal Injection-related Effects: Intravitreal injections, including those with ILUVIEN, have been associated with endophthalmitis, eye inflammation, increased or decreased intraocular pressure, and choroidal or retinal detachments. Patients should be monitored following the intravitreal injection. Patients may experience temporary blurred vision after injection of the implant.
  • Intraocular Pressure (IOP) Increase: Prolonged use of corticosteroids may result in the development of glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision. Steroids should be used with caution in the presence of glaucoma. Intraocular pressure should be routinely monitored during the course of the treatment.
  • Cataracts: The use of corticosteroids may result in posterior subcapsular cataract formation.
  • Delayed Corneal Wound Healing: The use of corticosteroids after cataract surgery may delay healing and increase the incidence of bleb formation.
  • Corneal and Scleral Melting: Various ocular diseases and long-term use of topical corticosteroids have been known to cause corneal and scleral thinning. Use of ophthalmic corticosteroids in the presence of thin corneal or scleral tissue may lead to perforation of the globe.
  • Bacterial Infections: Prolonged use of corticosteroids may suppress the host response and thus increase the hazard of secondary ocular infections. Acute purulent or parasitic infections of the eye may be masked or activity enhanced by the presence of corticosteroid medication. If signs and symptoms fail to improve after 2 days, the patient should be reevaluated.
  • Viral Infections: Use of ocular corticosteroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex). Employment of a corticosteroid medication in the treatment of patients with a history of herpes simplex requires great caution; frequent slit lamp microscopy is recommended.
  • Fungal Infections: Fungal infections of the cornea are particularly prone to develop coincidentally with long-term local corticosteroid application. Fungus invasion should be suspected in any persistent corneal ulceration where a corticosteroid has been used or is in use. Fungal cultures should be taken when appropriate.
  • Risk of Implant Migration: Patients in whom the posterior capsule of the lens is absent or has a tear are at risk of implant migration into the anterior chamber.

Adverse Reactions

Diabetic Macular Edema
Ocular adverse reactions reported by greater than or equal to 1% of patients in the two combined 3-year clinical trials following injection of ILUVIEN for diabetic macular edema include: cataract (82%), myodesopsia (21%), eye pain (15%), conjunctival hemorrhage (13%), posterior capsule opacification (9%), eye irritation (8%), vitreous detachment (7%), conjunctivitis (4%), corneal oedema (4%), foreign body sensation in eyes (3%), eye pruritus (3%), ocular hyperaemia (3%), optic atrophy (2%), ocular discomfort (2%), photophobia (2%), retinal exudates (2%), anterior chamber cell (2%), and eye discharge (2%). Non-ocular adverse reactions reported by greater than or equal to 5% of patients include: anemia (11%), headache (9%), renal failure (9%), and pneumonia (7%)

Increased Intraocular Pressure: IOP elevation greater than or equal to 10 mm Hg from baseline at any visit was seen in 34% of ILUVIEN patients versus 10% of sham patients. IOP elevation greater than or equal to 30 mm Hg was seen in 20% of ILUVIEN patients versus 4% of sham patients. 38% of the patients who received ILUVIEN were subsequently treated with IOP-lowering medications during the study versus 14% of sham patients. 5% of the patients who received ILUVIEN needed surgical intervention for elevated IOP versus 1% of sham patients

Cataracts and Cataract Surgery: The incidence of cataract development in patients who had a phakic study eye was higher in the ILUVIEN group (82%) compared with sham (50%). The median time of cataract being reported as an adverse event was approximately 12 months in the ILUVIEN group and 19 months in the sham group. Among these patients, 80% of ILUVIEN subjects versus 27% of sham-controlled subjects underwent cataract surgery, generally within the first 18 months (median month 15 for both ILUVIEN group and for sham) of the studies.

INDICATION

ILUVIEN is a corticosteroid indicated for:

  • the treatment of diabetic macular edema (DME) in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure.

Please see full Prescribing Information.

Customer Support

Tel: 1-844-445-8843

Email: customerservice@alimerasciences.com

Access Plus

Tel: 1-844-445-8843, Option 3

Summary Overview of AccessPlus

Adverse event reporting, medical inquiry, product returns or replacements

Tel: 1-844-445-8843

Fax: 1-678-990-5740

Email: pvalimerasciences@alimerasciences.com
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This site is for US audiences only. © Copyright 2025 ANI Pharmaceuticals, Inc. All rights reserved.
ILUVIEN is a registered trademark of Alimera Sciences, Inc., an ANI Pharmaceuticals, Inc. Company.
US-IL-2400025 10/2025

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.