Paladin Phase 4 Study Confirms ILUVIEN® Patients' Reduced Need for Multiple Treatments

Rhea-AI Summary

Alimera Sciences (Nasdaq: ALIM) presented findings from the PALADIN Phase 4 Safety Study at the annual American Academy of Ophthalmology conference. The study reveals that patients with diabetic macular edema (DME) treated with the ILUVIEN® implant experienced a 46% reduction in additional therapies required compared to other treatments. Notably, 25% remained treatment-free for 36 months, and patients showed significant improvements in visual acuity and retinal thickness. This data reinforces ILUVIEN's effectiveness in reducing treatment burdens and enhancing patient outcomes in DME management.

Positive

• ILUVIEN implant significantly reduces the need for anti-VEGF, corticosteroids, and laser therapy by 46%.
• 25% of patients remained free of supplemental treatment over a 36-month period.
• Patients experienced average improvements in visual acuity and a decrease in retinal thickness.

Negative

• None.

Data from the Phase 4 observational real-world safety study of the intravitreal implant were presented at the annual American Academy of Ophthalmology (AAO) conference.

ATLANTA, Oct. 06, 2022 (GLOBE NEWSWIRE) -- Alimera Sciences, Inc. (Nasdaq: ALIM) (“Alimera”), a global pharmaceutical company whose mission is to be invaluable to patients, physicians, and partners concerned with retinal health and maintaining better vision longer, 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 ILUVIEN® (fluocinolone acetonide intravitreal implant) 0.19 mg was lower than from patients on other regimens. ILUVIEN 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 ILUVIEN and after injection of ILUVIEN.

• ILUVIEN treatment significantly reduced the number of eyes requiring anti-VEGF, corticosteroid, and laser therapy and reduced the total number of therapies administered by 46%.
• 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."

Also of note, PALADIN phase 4 data demonstrate ILUVIEN 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 ILUVIEN’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" said Rick Eiswirth, Alimera President and Chief Executive Officer. "Dr. Mansour's abstract provides real-world evidence that ILUVIEN patients have the opportunity to enjoy more time between injections while on continuous treatment."

ILUVIEN is a sustained release intravitreal 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.

About PALADIN
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. Full study details are available here.

About ILUVIEN
www.ILUVIEN.com
The Company’s sole product is ILUVIEN (fluocinolone acetonide intravitreal implant) 0.19 mg sustained release intravitreal implant, injected into the back of the eye. With its CONTINUOUS MICRODOSING™ technology, ILUVIEN is designed to release sub-microgram levels of fluocinolone acetonide, a corticosteroid, for 36 months, to reduce the recurrence of disease and number of treatments required, enabling patients to maintain vision longer with fewer injections. ILUVIEN® (fluocinolone acetonide intravitreal implant) 0.19 mg is indicated in the U.S. 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. For safety information please visit https://iluvien.com/#isi and scroll down the page.

About Alimera Sciences, Inc.
www.alimerasciences.com
Alimera Sciences a global pharmaceutical company whose mission is to be invaluable to patients, physicians and partners concerned with retinal health and maintaining better vision longer. For more information, please visit www.alimerasciences.com.

For press inquiries: Cassy Dump for Alimera Sciences 619-971-1887 cassy.dump@precisionvh.com

For investor inquiries: Scott Gordon for Alimera Sciences scottg@coreir.com

FAQ

What were the findings of the PALADIN Phase 4 Safety Study presented by Alimera Sciences?

The PALADIN study showed that ILUVIEN significantly reduced the need for additional therapies in DME patients by 46%.

How long can ILUVIEN provide treatment for diabetic macular edema?

ILUVIEN provides continuous therapy for up to 36 months.

What percentage of patients using ILUVIEN did not require supplemental treatment?

25% of patients remained free of supplemental treatment through 36 months.

What is the significance of the results from the PALADIN study for DME patients?

The study indicates ILUVIEN's effectiveness in reducing treatment burden and improving patient outcomes.

When was the data from the PALADIN study presented?

The data was presented at the annual American Academy of Ophthalmology conference on October 6, 2022.