Alimera Completes Recruitment for its Landmark NEW DAY Study
Study has Now Reached Goal of 300 Patients Enrolled to Evaluate ILUVIEN as First Line, Baseline Therapy for Diabetic Macular Edema
ATLANTA, May 24, 2023 (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, today announces that it has completed enrollment for the company’s NEW DAY clinical trial, a randomized, controlled, multi-center study designed to generate prospective data for ILUVIEN® (fluocinolone acetonide intravitreal implant) 0.19 mg as a baseline therapy in patients diagnosed with diabetic macular edema (DME).
“We believe that this study is the largest head-to-head comparison of any corticosteroid therapy and anti-VEGF therapy in the treatment of newly diagnosed patients suffering from DME. From this study, we look forward to sharing data in early 2025, which we expect will support a change to the current paradigm of DME treatment, offering patients a first-line treatment option that can maintain vision longer with fewer injections than other therapies,” said Rick Eiswirth, Alimera’s President and Chief Executive Officer. “We continue to have great confidence in this study as our most recent PALADIN data further indicated that the benefits of ILUVIEN are realized earlier when used early in DME treatment. We would like to thank all the investigators, staff and patients who are participating in our NEW DAY Study.”
About the NEW DAY Study
The NEW DAY Study is a multicenter, single-masked, randomized, controlled trial designed to generate prospective data evaluating ILUVIEN as a baseline therapy in the treatment of DME and demonstrate its potential advantages over the current standard of care of repeat anti-VEGF (aflibercept) injections. The NEW DAY Study currently has enrolled approximately 300 treatment-naïve, or near naïve, DME patients in approximately 42 sites around the U.S.
Patients who meet the entry criteria are randomized to receive either five injections of intravitreal aflibercept 2 mg at four-week intervals for the first 16 weeks as a loading dose or an ILUVIEN intravitreal implant. After the initial 16-week period, both arms are evaluated every 4 weeks and receive supplemental intravitreal injections of aflibercept 2 mg only as needed. Criteria for supplemental treatment is set by protocol and identical in both treatment arms. The treatment period in the study is 18 months.
The primary outcome measure for the NEW DAY Study is the mean number of supplemental aflibercept injections needed during the trial between treatment groups. Key secondary endpoints include mean best corrected visual acuity (BCVA) score over time, time to first supplemental treatment, measures of retinal thickness variability based on optical coherence tomography (OCT), and diabetic retinopathy scores. In addition, the study will collect patient-reported outcome measures evaluating the effect on patients’ quality of life and level of functioning. Exploratory endpoints include neuronal functional measures and OCT imaging measures of retinal nerve layer thickness.
Full study details are available at https://clinicaltrials.gov
About ILUVIEN
www.ILUVIEN.com
The Company’s primary 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, enabling patients to maintain vision longer with fewer injections. ILUVIEN is approved in the U.S., Canada, Kuwait, Lebanon and the U.A.E. to treat 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. In 17 European countries, ILUVIEN is indicated for the treatment of vision impairment associated with chronic DME considered insufficiently responsive to available therapies. In March 2019, ILUVIEN received approval in the 17 countries under the Mutual Recognition Procedure for prevention of relapse in recurrent non-infectious uveitis affecting the posterior segment of the eye. The 17 European countries include the U.K., Germany, France, Italy, Spain, Portugal, Ireland, Austria, Belgium, Denmark, Norway, Finland, Sweden, Poland, Czechia, the Netherlands, and Luxembourg.
ILUVIEN is marketed for the non-infectious posterior uveitis indication in Germany, France, the U.K., the Netherlands, Portugal, Spain, Austria, Ireland and Italy. ILUVIEN is not approved for treatment of uveitis in the United States.
About Alimera Sciences, Inc.
Alimera Sciences is 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 with respect to the anticipated results of the NEW DAY Study. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties (some of which are beyond Alimera’s control), including factors that could delay, divert or change any of them, and could cause actual results to differ materially from those projected in these forward-looking statements. 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 recently filed Quarterly Report on Form 10-Q, most recently filed Annual Report on Form 10-K, and any of Alimera’s subsequent filings with the Securities and Exchange Commission (SEC) and available on the SEC’s website at www.sec.gov.
All forward-looking statements contained in this press release are expressly qualified by the cautionary statements contained or referred to herein. Alimera cautions investors not to rely on the forward-looking statements Alimera makes or that are made on its behalf as predictions of future events. These forward-looking statements speak only as of the date of this press release. Alimera undertakes no obligation, and specifically declines any obligation, to publicly update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws.
| For press inquiries: Jules Abraham for Alimera Sciences 917-885-7378 julesa@coreir.com | For investor inquiries: Scott Gordon for Alimera Sciences scottg@coreir.com |
