Phase 4 PALADIN results confirm durability of fluocinolone acetonide intravitreal implant for DME

Alimera Sciences Inc. announced today that the PALADIN Phase 4 Study confirms the safety of fluocinolone acetonide intravitreal implant (Iluvien) 0.19 mg sustained release intravitreal implant and provides a durable treatment option that reduces the frequency of recurrence for patients with diabetic macular edema (DME).

Rick Eiswirth, president and CEO of Alimera, noted in a news release that the company is pleased to have had the opportunity to have great data from its PALADIN Study of fluocinolone acetonide intravitreal implant presented at the recent ASRS annual meeting in New York.

“For the last few years, we have been refocusing our messaging on the ability of Iluvien to treat DME consistently to gain better control,” Eiswirth said. “Dr. Riemann’s abstract correlating reduced retinal thickness variability and better visual acuity demonstrates the value of Iluvien’s continuous microdosing.”

According to the company, the 3-year phase IV, real-world observational PALADIN study evaluated the long-term safety of Iluvien for patients with DME. This study confirms 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.

The results were presented for two of the abstracts at the annual ASRS conference held earlier this month in New York, and one is available on the online demand portal and these include”

• Christopher Riemann, MD, a vitreoretinal surgeon at the Cincinnati Eye Institute in Ohio, presented the abstract he authored titled “Three-Year Outcomes of the PALADIN Phase IV Study: Comparison of Anatomical Metrics, Efficacy, and Treatment Burden Post FAc.”
• Victor Gonzalez, MD, a retina specialist at Valley Retina Institute in McAllen, Texas presented a second abstract, titled “0.19 mg Fluocinolone Acetonide Implant Leads to Superior Vision, Anatomical, and Treatment Burden Outcomes in Eyes with Better Baseline Visual Acuity (≤ 20/40).”
• Pauline Merrill, MD, physician emeritus with Illinois Retina and Associate Professor, Ophthalmology, Rush University Medical Center, "Three Year Outcomes from the PALADIN Phase IV Study: A Deep Dive into Eyes Requiring IOP Lowering Surgery."

Amongst the exploratory findings presented in these abstracts were:

• Eyes were under treated with 3.5 mean yearly treatments during the three years prior to the administration of ILUVIEN and lost on average 6.4 ETDRS letters during that time. Following the administration of ILUVIEN, eyes gained 4.5 ETDRS letters on average and treatment frequency was reduced to 1.7 mean yearly treatments.
• Significantly more eyes were able to achieve a dry retina (central subfield thickness (CST) ≤ 300 µm) following FAc administration when compared to baseline.
• Eyes experienced significantly less retinal thickness variability post-FAc treatment compared to baseline, as measured by retinal thickness amplitude (RTA) and standard deviation (RTSD).
• Reduced retinal thickness variability was shown to correlate with improved visual outcomes and better disease control.
• Eyes were able to maintain or improve their vision after receiving the 0.19 mg FAc implant regardless of their baseline visual acuity.
• Eyes with a baseline BCVA ≥ 20/40 maintained their good vision (baseline: mean 77.5 letters; month 36: mean 75.5 letters)
• Eyes with a baseline visual acuity < 20/40 significantly improved their vision by 8.2 letters on average (baseline: mean 53.1 letters; month 36: mean 61.3 letters)
• Better baseline visual acuity was also associated with a lower incidence of incisional IOP surgery and led to numerically fewer IOP-related events.
• In the eyes requiring IOP-lowering surgery (6 eyes), the IOP was managed and eyes gained 7.3 letters on average by the end of the study.

“The data verify that Iluvien provides physicians with a much-needed tool for safe and durable treatment of DME,” Riemann said in the news release. “The Iluvien implant lessens the burden of care for our patients, reducing their inflammation with fewer doctor visits while maintaining or even improving their vision.”

According to the company, the PALADIN study is 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 confirmed improvement in vision and reduction in treatment burden and retinal thickness variability.