Phase 4 PALADIN Study with ILUVIEN® Published in Peer-Reviewed Journal Ophthalmology
- Best corrected visual acuity and central subfield thickness were significantly improved at 36 months
- ILUVIEN treatment resulted in a 70.5% reduction in treatment burden
- Results confirm that use of prior corticosteroid per the U.S. label mitigates the risk of IOP lowering surgery
ATLANTA, Feb. 23, 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 the 3-year results of the PALADIN study have been published in the peer-reviewed journal Ophthalmology.
These study results show that patients with diabetic macular edema (DME) who received a single dose of the sustained release implant ILUVIEN (fluocinolone acetonide intravitreal implant) 0.19 mg demonstrated statistically significant improvements in best corrected visual acuity, central subfield thickness, and treatment burden at 36 months. Treatment frequency for patients in the PALADIN Study was reduced by 70.5% from a median of 3.4 treatments per year in the 36 months preceding the injection of ILUVIEN to a median of 1.0 treatments per year in the 36 months following the ILUVIEN injection. Further, 2.97% of eyes required IOP lowering surgery, only half of which were due to steroid induced ocular hypertension following the administration of ILUVIEN in accordance with the U.S. label. This compares favorably to the 4.8% in the pivotal FAME Studies. For full publication click Here.
A post hoc analysis of 36-month data from PALADIN found that patients with ≤6 treatments for DME before ILUVIEN administration experienced significantly higher visual acuity gains from baseline compared with patients who had >6 treatments before receiving ILUVIEN (5.70 letters, P=.0048 vs 1.78 letters, P = .8337). These findings suggest that use of ILUVIEN earlier in a treatment algorithm for DME could lead to more desirable visual acuity outcomes.
“We are very pleased to see confirmation from the PALADIN study that the side effect risk of intraocular pressure can be effectively mitigated when ILUVIEN is used in accordance with our U.S. FDA label,” said Rick Eiswirth, Alimera’s President and CEO. “Additionally, we are excited that the PALADIN Study provides another data set demonstrating ILUVIEN’s ability to improve visual acuity with fewer treatment interventions and further supports the hypothesis of our NEW DAY Study.”
The PALADIN study was a phase 4, open-label, prospective, observational study conducted over 36 months at 41 sites across the United States. The 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 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.
“The 3-year results of the PALADIN study demonstrate ILUVIEN’s ability to safely and effectively improve visual acuity and retinal anatomy while also reducing the recurrence of edema as evidenced by the decreased treatment burden in patients with DME,” said Michael Singer, MD, Clinical Professor of Ophthalmology, University of Texas Health Science Center, San Antonio, and Director of Clinical Research Medical Center Ophthalmology, San Antonio, Texas. “This is especially important for the diabetic population. Many diabetics are actively working and would otherwise be subject to a high treatment burden of injections that are currently required with anti-vegf therapy alone These findings further support that earlier use of ILUVIEN in a treatment algorithm for DME could lead to more desirable anatomical and functional outcomes.”
Primary outcomes included changes in IOP and interventions to manage IOP elevations; secondary outcomes examined visual, anatomic, and treatment burden–related outcomes. Among the findings at 36 months:
- Mean best corrected visual acuity increased by 3.61 letters (P = .0222) from baseline.
- Mean central subfield thickness decreased by 60.69 µm (P < .0001) from baseline.
- Patients received median 1.0 treatment per year after receiving ILUVIEN. In the 36-month period immediately preceding ILUVIEN administration, patients received median 3.4 treatments per year. Thus, ILUVIEN treatment resulted in a 70.5% reduction in treatment burden.
- Surgery to address elevated IOP occurred in 2.97% of eyes; only 1.49% of patients received surgery due to steroid related IOP elevation, with the remaining cases of IOP elevation chiefly attributed to neovascular glaucoma.
- IOP response ≤25 mm Hg after the steroid challenge predicted a similar outcome after ILUVIEN treatment at the final visit in 96.9% of eyes.
- Mean IOP remained stable throughout the study, and IOP increases of >30 mm Hg occurred in only 10.9% of eyes. IOP increases that occurred were considered manageable with standard treatments, according to the study authors.
Full study details are available here.
About Diabetic Macular Edema (DME)
DME, the primary cause of vision loss associated with diabetic retinopathy, is a disease affecting the macula, the part of the retina responsible for central vision. When the blood vessel leakage associated with diabetic retinopathy results in swelling of the macula, the condition is called DME. The onset of DME is painless and may go unreported by the patient until it manifests with the blurring of central vision or acute vision loss. The severity of this blurring may range from mild to profound loss of vision. The Wisconsin Epidemiologic Study of Diabetic Retinopathy found that over a 10-year period, approximately 19% of people with diabetes included in the study were diagnosed with DME. All people with type 1 or type 2 diabetes are at risk of developing DME.
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.
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.
Forward Looking Statements
This press release contains “forward-looking statements,” within the meaning of the Private Securities Litigation Reform Act of 1995, regarding, among other things, Alimera’s expectations regarding (i) the receptiveness of physicians to PALADIN data suggesting that use of ILUVIEN earlier in a treatment algorithm for DME could lead to more desirable visual acuity outcomes and (ii) the ability of the NEW DAY study to demonstrate the efficacy of ILUVIEN as a baseline therapy for early treatment of diabetic macular edema (DME).
Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual results to differ materially from those projected in its forward-looking statements. Meaningful factors which could cause actual results to differ include, among other things, (a) uncertainties associated with the acceptance of the PALADIN study results and physicians’ willingness to modify their treatment decisions accordingly, (b) the continued effects of COVID-19 on physicians and their practices and patients, and (c) the possibility that the NEW DAY Study may fail to demonstrate the efficacy of ILUVIEN as baseline therapy in patients with early DME or to generate data demonstrating the benefits of ILUVIEN when compared to the current leading therapy for DME, as well as the other factors are discussed in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of Alimera’s Annual Report on Form 10-K for the year ended December 31, 2020 and Quarterly Reports on Form 10-Q for the quarters ended March 31, 2021, June 30, 2021, and September 30, 2021 which are on file with the Securities and Exchange Commission (SEC) and available on the SEC’s website at www.sec.gov. Additional factors will also be described in those sections, and in the Summary of Principal Risk Factors section, of Alimera’s Annual Report on Form 10-K for the year ended December 31, 2021, to be filed with the SEC soon.
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