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at the PALADIN Study results

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.

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

  • 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.

  • The 94 eyes that completed 36 months 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. *

  • 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.
*Data on file. Alimera Sciences, Inc. MI-DOF-062

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

  • A subgroup analysis of BCVA suggested that, overall, the highest gains in vision occurred in patients with fewer treatments prior to ILUVIEN.
 
  • Patients with 6 or fewer prior treatments had a mean gain of 5.7 letters while patients who received more than 6 prior treatments had a mean gain of only 1.8 letters.

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

  • 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 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.

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

  • IOP increases that occurred were considered manageable with standard treatments.

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

  • 20% of eyes required IOP-lowering medication.

  • 2.97% of eyes required IOP-lowering surgery, half of which were due to neovascular glaucoma. This compares favorably 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.

     

Key Messages from PALADIN Study:

  • 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.

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%).

Please see full Prescribing Information.

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