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Clinical Studies & Data

ILUVIEN Clinical Studies

The clinical studies of ILUVIEN demonstrate the product’s effectiveness, safety and durability in IOP predictability, vision improvement, and the reduction in treatment burden and retinal thickness variability.

FAME Study

USER Study

PALADIN Study

FAME Study 1

In the ILUVIEN Phase 3 clinical trials (FAME), there was a sustained improvement in visual acuity (VA) and reduction in retinal edema for up to 3 years, indicating treatment durability.

ILUVIEN was evaluated in 2 prospective, randomized, multicenter, double-masked, parallel 3-year clinical trials (FAME A and FAME B).

ILUVIEN was studied in patients whose diabetic macular edema (DME) persisted or recurred despite treatment.

The ILUVIEN Phase 3 clinical trials assessed patients with DME who had previously been treated with laser photocoagulation.

Patients were treated with either ILUVIEN or sham injection (2:1).

All patients were allowed to receive rescue laser any time after week 6 for persistent edema or recurrent DME, if necessary, and an additional implant after month 12.

 

560 Patients

561 Eyes

103 Clinical Centers

To see the full study design, click below:

FAME STUDY DESIGN

Key Messages from the FAME Study:

  • In ILUVIEN Phase 3 clinical trials, mean retinal thickness was reduced and maintained throughout the 36-month study period.
  • In the pivotal ILUVIEN FAME studies, no patient treated after prior ophthalmic steroid injection required surgical intervention for elevated IOP.
  • 34% of ILUVIEN patients had IOP elevation ≥ 10 mmHg from baseline, as compared to 10% in the sham injection group.
  • 20% of ILUVIEN patients had IOP elevation ≥ 30 mmHg from baseline, as compared to 4% in the sham injection group.

FAME study data: Impact of prior ophthalmic corticosteroid injection on IOP-lowering surgery2

*For a minimum of 7 days

The FDA indication differs from the FAME study inclusion criteria due to the requirement for “a prior course of corticosteroid without a clinically significant rise in IOP.” Seventy-two patients in the pivotal ILUVIEN FAME studies previously had an ophthalmic steroid injection and did not fall into the exclusion criteria “patients with a history of uncontrolled IOP elevation with steroid use that did not respond to topical therapy.”2

In ILUVIEN Phase 3 clinical trials, mean retinal thickness was reduced and maintained throughout the 36-month study period1

Percent of patients with an increase of ≥ 15 letters in BCVA from baseline.

Change in mean center point thickness for all patients.

*Denotes significance compared to baseline, p<0.05.

USER Study3

The USER Study provides valuable, real-world clinical insights on visual acuity (VA), edema, and safety before and after ILUVIEN implantation. When used per label, ILUVIEN has a predictable IOP profile following a steroid challenge.

Results confirm the safety and efficacy profile of ILUVIEN. ILUVIEN significantly reduced treatment burden without significantly increasing the risk of steroid-induced pressure elevation.

USER was a retrospective study of 160 eyes in 130 patients receiving ILUVIEN.

130 Patients

160 Eyes

4 U.S. Clinical Centers

Key Messages from the USER Study:

  • Patients treated with ILUVIEN with good starting VA (≥ 20/40) maintained VA and those that started with poor VA had improved VA while experiencing a significant reduction in treatment frequency.
  • No additional DME treatment was required in 63% of eyes throughout follow-up (mean of 403 days).
  • Patients treated with ILUVIEN had a decrease in retinal thickness on average.
  • After treatment with ILUVIEN, the proportion of eyes with “normal” CST (≤ 300 microns) increased over time.
  • USER data showed no significant difference in rates of IOP-related events before and after ILUVIEN treatment.
  •  

Patients treated with ILUVIEN with good starting VA maintained VA and those that started with poor VA had improved VA while experiencing a significant reduction in treatment frequency. Regardless of VA at the time of ILUVIEN treatment, patients required fewer DME treatments on average after ILUVIEN.3

DME treatment frequency before and after ILUVIEN treatment, entire population
(N=160).

Mean follow-up after ILUVIEN was 403 days, with 102 eyes followed up for 6 months, 92 for 12 months, and 88 for 15 months. The number of patients available for follow-up at each time point varied.

Patients treated with ILUVIEN had a decrease in retinal thickness on average.3

Central subfield thickness (CST), OCT population (N=120 eyes).

The numbers in parentheses represent the number of eyes with data at those time points.

After treatment with ILUVIEN, the proportion of eyes with “normal” CST (≤ 300 microns) increased over time.3

Percentage of eyes with CST ≤ 300 microns, OCT population (N=120 eyes).

The numbers in parentheses represent the number of eyes with data at those time points.

USER data showed no significant difference in rates of IOP-related events before and after ILUVIEN treatment.3

IOP-related events before and after ILUVIEN, entire population
(N=160 eyes).

Patients who had an IOP response of ≤ 25 mmHg associated with a prior steroid treatment were 94% to 98% likely to have an IOP response ≤ 25 mmHg associated with ILUVIEN.

A 94% predictive value is calculated using the maximum IOP measured on ILUVIEN and a 98% predictive value is calculated using the last measured IOP value on ILUVIEN.

In patients treated per label, ILUVIEN had a predictable intraocular pressure (IOP) profile.3

IOP-lowering medication on day of and after ILUVIEN, entire population (N=160 eyes).

USER data showed no significant increase in the number of patients treated with IOP-lowering medication after ILUVIEN treatment (p=0.169).

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.

PALADIN Study 4

The three-year, phase IV, real-world observational PALADIN study evaluated the long-term safety of ILUVIEN for patients with DME. This study data supports the benefit of using a prior course of corticosteroid to mitigate the risk of uncontrolled IOP elevations. The study also reported secondary outcomes of vision improvement and reduction in treatment burden and retinal thickness variability.

There were a total of 202 eyes of 159 patients enrolled in the study. The mean follow-up length for these eyes was 27.6 months and 94 eyes completed 36 months of follow-up.

159 Patients

202 Eyes

38 U.S. Clinical Centers

Key messages from the PALADIN Study:

  • IOP response with ILUVIEN was stable, predictable, and manageable.
  • ILUVIEN significantly reduced retinal edema demonstrating management of DME caused by inflammation.
  • Patients on ILUVIEN had positive visual outcomes with significant gains in BCVA and best visual outcomes were in patients treated earlier in their DME treatment regimen.
  • ILUVIEN patients benefited from a significant reduction in their DME treatment burden throughout the 36-month follow-up period.

IOP response with ILUVIEN was stable, predictable, and manageable.4

IOP increases that occurred were considered manageable with standard treatments.

IOP increases of > 30 mmHg occurred in 10.9% of eyes.

30.19% of eyes required IOP-lowering medication.5

Incisional IOP-lowering surgical rate for all eyes was 3.96% with 2.47% due to steroid use and 1.49% due to neovascular glaucoma.5 This compares favorable to the 4.8% seen in the pivotal FAME Studies.

IOP response ≤ 25 mmHg after the steroid challenge predicted a similar outcome after ILUVIEN treatment at the final visit in 97% of eyes.

IOP data for all eyes (N=202) with mean follow-up duration of 27.6 months.

ILUVIEN significantly reduced retinal edema demonstrating sustained management of DME caused by inflammation.4

The 94 eyes that completed 36 months reached a statistically significant decrease in CST, a measure of edema, at all time-points measured in the study, compared to baseline.

Mean change in CST was -60.7 microns (p<0.0001).

Patients on ILUVIEN experienced meaningful gains in BCVA.4

At 36 months, eyes experienced a mean 3.6 letter increase in BCVA. Prior to ILUVIEN, eyes experienced a mean change of -8.4 letters despite most patients having received prior DME treatment.6

Eyes with a good starting vision (20/40 or better) were able to maintain their good vision. Eyes with a baseline BCVA of worse than 20/40 were able to significantly improve their vision (mean +6.5 letters, p=0.0069).

BCVA gains were significant at most time points throughout the study.

The PALADIN Study demonstrates the visual-outcome benefits of using ILUVIEN earlier in a DME treatment regimen.4

A subgroup analysis of BCVA looked at the number of prior treatments and retinal dryness at baseline as probable indicators for patients treated earlier in their DME treatment regimen.
 
The highest gains in visual acuity were noted in patients with fewer (≤ 6) prior treatments and in eyes with the driest retina at baseline (quartile 1, 163.0-281.0 µm) gaining 5.7 letters and 6.1 letters, respectively, compared with baseline.

ILUVIEN patients benefited from a significant reduction in their DME treatment burden throughout the 36-month follow-up period.4

In the up-to-3-year period prior to ILUVIEN, study eyes received a median of 3.4 treatments per year. During the 3-year follow-up period with the ILUVIEN implant in place, the median treatment frequency declined to just 1 supplemental treatment per year. This represents a 70.5% reduction in median yearly treatment burden for patients.

Among eyes that completed 36 months of the study, 25% of eyes did not require any supplemental treatments during the study.

INDICATION AND IMPORTANT SAFETY INFORMATION

Indication

ILUVIEN® (fluocinolone acetonide intravitreal implant) 0.19 mg is 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.

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.

Indication

ILUVIEN® (fluocinolone acetonide intravitreal implant) 0.19 mg is 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.

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 injections, including those with ILUVIEN, have been associated with endophthalmitis, eye inflammation, increased intraocular pressure, and retinal detachments. Patients should be monitored following the intravitreal injection.
  • Use of corticosteroids including ILUVIEN may produce posterior subcapsular cataracts, increased intraocular pressure and glaucoma. Use of corticosteroids may enhance the establishment of secondary ocular infections due to bacteria, fungi, or
    viruses. Corticosteroids are not recommended to be used in patients with a history of ocular herpes simplex because of the potential for reactivation of the viral infection.
  • 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

  • In controlled studies, the most common adverse reactions reported were cataract development (ILUVIEN 82%; sham 50%) and intraocular pressure elevation of ≥ 10 mm Hg (ILUVIEN 34%; sham 10%).

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Study 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:

956 subjects randomized 2:2:1

  • 0.2 μg/day FAc intravitreal insert
  • 0.5 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 treatment 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.

References:

  • 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;119:2125-2132.
  • 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.

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

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.

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

References

  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.

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References

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. Parrish RK, et al. 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.
  3. 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.
  4. Singer MA, et al. Three-Year 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.
  5. Data on file. Alimera Sciences, Inc. MI-DOF-068.
  6. Data on file. Alimera Sciences, Inc. MI-DOF-062.

References

  1. Rübsam A, et al. Role of Inflammation in Diabetic Retinopathy. Int J Mol Sci. 2018;19(4):942.
  2. Teodoro JS, et al. Therapeutic Options Targeting Oxidative Stress, Mitochondrial Dysfunction and Inflammation to Hinder the Progression of Vascular Complications of Diabetes. Front Physiol. 2019;9:1857.
  3. Ciulla TA and Hussain RM. Long-term outcomes of Anti-VEGF Therapy. Retina Today. 2021;November/December 2021:40-47.
  4. Starr MR, et al. Fluctuations in Central Subfield Thickness Associated With Worse Visual Outcomes in Patients With Diabetic Macular Edema in Clinical Trial Setting. Am J Ophthalmol. 2021;232:90-97.
  5. Kiss S, et al. Clinical utilization of anti-vascular endothelial growth-factor agents and patient monitoring in retinal vein occlusion and diabetic macular edema. Clin Ophthalmol. 2014;8:1611-1621.
  6. 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.
  7. Deuchler SK, et al. Vitreous cytokine levels following the administration of a single 0.19 mg fluocinolone acetonide (ILUVIEN®) implant in patients with refractory diabetic macular edema (DME)-results from the ILUVIT study. Graefes Arch Clin Exp Ophthalmol. 2022;260(8):2537-2547.
  8. Romero-Aroca P, et al. Diabetic Macular Edema Pathophysiology: Vasogenic versus Inflammatory. J Diabetes Res. 2016;2016:2156273.

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. Shah, P and Westwell A. The role of fluorine in medicinal chemistry, J Enzyme Inhib Med Chem 2007; 22 (5):527-540.
  5. Adán A, et al. Clinical-Decision Criteria to Identify Recurrent Diabetic Macular Edema Patients Suitable for Fluocinolone Acetonide Implant Therapy (ILUVIEN®) and Follow-Up Considerations/ Recommendations. Clinical Ophthalmology (Auckland, N.Z.) 2020; 14: 2091–2107.
  6. Sohn HJ, et al. Changes in aqueous concentrations of various cytokines after intravitreal triamcinolone versus bevacizumab for diabetic macular edema. Am J Ophthalmol. 2011;152(4):686-694.
  7. Deuchler SK, et al. Vitreous cytokine levels following the administration of a single 0.19 mg fluocinolone acetonide (ILUVIEN®) implant in patients with refractory diabetic macular edema (DME)-results from the ILUVIT study. Graefes Arch Clin Exp Ophthalmol. 2022;260(8):2537-2547.
  8. Rübsam A, et al. Role of Inflammation in Diabetic Retinopathy. Int J Mol Sci. 2018;19(4):942.
  9. 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. 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.

References

1. Data on file. Alimera Sciences, Inc.

References

1. Data on file. Alimera Sciences, Inc.