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Paladin Phase 4 study confirms fluocinolone acetonide intravitreal implant patients' reduced need for multiple treatments


Data from the Phase 4 observational real-world safety study of the intravitreal implant were presented at the annual American Academy of Ophthalmology’s 2022 annual conference in Chicago.

Alimera Sciences Inc. announced today that post-hoc analyses from the PALADIN Phase 4 Safety Study demonstrate that median treatment frequency in diabetic macular edema (DME) patients treated with the fluocinolone acetonide intravitreal implant (ILUVIEN) 0.19 mg was lower than from patients on other regimens.

According to the company, fluocinolone acetonide intravitreal implant provides DME patients with continuous therapy for up to 36 months. As part of the PALADIN phase 4 study, investigators sought to quantify the treatments required by eyes prior to fluocinolone acetonide intravitreal implant and after injection of fluocinolone acetonide intravitreal implant.

Fluocinolone acetonide intravitreal implant treatment significantly reduced the number of eyes requiring anti-VEGF, corticosteroid, and laser therapy and reduced the total number of therapies administered by 46%.

Moreover, the comapny noted that 25% of eyes remained supplemental treatment free through 36 months.

"The ILUVIEN implant provides an advantage over shorter-acting therapies where patient adherence and durability are of concern," said Sam E. Mansour, MD, Medical Director of the Virginia Retina Center, Warrenton, Virginia. "This analysis from the 3-year PALADIN phase 4 study provides further evidence of the utility of ILUVIEN by demonstrating a significant reduction in the eyes requiring additional DME therapy as well as the number of treatments needed to manage DME symptoms post-FAc."

The company also noted that PALADIN phase 4 data demonstrate fluocinolone acetonide intravitreal implant patients experienced on average an increase in visual acuity, a significant decrease in retinal thickness and a predictable and manageable safety profile over 36 months. Combined with the evidence from prior studies, the PALADIN study data further support fluocinolone acetonide intravitreal implant’s value as a durable DME therapy.

"The treatment burden for DME patients is high and many factors contribute to medication noncompliance when it comes to therapy, increasing the chances of sub-optimal outcomes" Rick Eiswirth, Alimera president and CEO, said in the news release. "Dr. Mansour's abstract provides real-world evidence that ILUVIEN patients have the opportunity to enjoy more time between injections while on continuous treatment."

According to the comapny, the intravitreal implant is a sustained release implant indicated in the United States 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.

The PALADIN study was a phase 4, open-label, prospective, observational study conducted over 36 months at 41 sites across the United States. This study was designed and developed to confirm the benefit of using a prior course of corticosteroid as indicated in the ILUVIEN U.S. label, to mitigate the risk of uncontrolled IOP elevation. Researchers enrolled 202 eyes in 159 patients with DME who had previously received corticosteroid treatment without a clinically significant rise in IOP.

All eyes were treated with ILUVIEN and patients were followed for up to 36 months. Additionally, secondary outcomes included on average improvement in vision and reduction in treatment burden and retinal thickness variability.

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