Alimera Sciences Announces Enrollment of First Patient in Landmark NEW DAY Clinical Trial to Evaluate ILUVIEN® as Baseline Therapy for Diabetic Macular Edema
Alimera Sciences (Nasdaq: ALIM) has commenced its NEW DAY clinical trial, enrolling its first patient to evaluate ILUVIEN as a baseline therapy for diabetic macular edema (DME). The randomized, controlled study will involve approximately 300 treatment-naïve patients across 42 U.S. sites. The primary aim is to compare the mean number of supplemental aflibercept injections needed between ILUVIEN and standard treatment. Previous studies have indicated ILUVIEN's potential for prolonged vision maintenance with fewer injections, marking a significant step in DME treatment strategies.
- Initiation of NEW DAY trial, a key step in evaluating ILUVIEN's efficacy.
- Potential for ILUVIEN to enhance DME treatment paradigm, possibly reducing injection frequency.
- The NEW DAY Study may not demonstrate ILUVIEN's efficacy as a baseline DME therapy.
- Challenges in recruiting sufficient clinical sites and patients for the NEW DAY Study.
ATLANTA, Sept. 01, 2020 (GLOBE NEWSWIRE) -- Alimera Sciences, Inc. (Nasdaq: ALIM) (Alimera), a global pharmaceutical company that specializes in the commercialization and development of prescription ophthalmic pharmaceuticals for the treatment of retinal diseases, announces that it has enrolled the first patient in 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).
“The first patient enrolled in our NEW DAY trial is an important milestone initiating the opportunity to generate data that we believe has the potential to change the paradigm of DME treatment by offering patients a first-line treatment option that can maintain vision longer with fewer injections,” said Rick Eiswirth, Alimera’s President and Chief Executive Officer. “We have great confidence in this study as our FAME Study data supported the approval of ILUVIEN as first-line therapy in the U.S., and our real-world data from both the U.S. and Europe indicate that the benefits of ILUVIEN are maximized when used early in DME.”
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 (afilbercept) injections. The NEW DAY Study is planned to enroll approximately 300 treatment-naïve, or almost naïve, DME patients in approximately 42 sites around the U.S.
Patients who meet the entry criteria will be 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 will be 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 will be identical in both treatment arms. The planned treatment period in the study is 18 months. Once the treatment period is concluded, patients will be given the option to participate in an open label extension study for up to 42 months.
The primary outcome measure for NEW DAY 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 up to 18 months, time to first supplemental treatment, retinal thickness amplitude on optical coherence tomography (OCT), and diabetic retinopathy scores. In addition, the study will collect patient-reported outcome measures to evaluate the effect on patients’ quality of life and level of functioning. Exploratory endpoints will include neuronal functional measures and OCT imaging measures of retinal nerve layer thickness.
Full study details are available at https://clinicaltrials.gov
About ILUVIEN
ILUVIEN (fluocinolone acetonide intravitreal implant) 0.19 mg is a sustained release intravitreal implant, injected into the back of the eye. With its CONTINUOUS MICRODOSINGTM technology, ILUVIEN is designed to release submicrogram levels of fluocinolone acetonide, a corticosteroid, for up to 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 and for prevention of relapse in recurrent non-infectious uveitis affecting the posterior segment of the eye. ILUVIEN is not approved for treatment of uveitis in the United States.
About Alimera Sciences, Inc.
Alimera Sciences is a pharmaceutical company that specializes in the commercialization and development of prescription ophthalmic pharmaceuticals. Alimera is presently focused on diseases affecting the back of the eye, or retina, because these diseases are not well treated with current therapies and affect millions of people in our aging populations. 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 belief that ILUVIEN has the potential to change the paradigm of DME treatment, and Alimera’s belief that the benefits of ILUVIEN are maximized when used early in DME.
Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change these expectations, and could cause actual results to differ materially from those projected in these forward-looking statements. Meaningful factors that could cause actual results to differ include but are not limited to, the NEW DAY Study may fail to demonstrate the efficacy of ILUVIEN as a baseline DME therapy, Alimera may be unable to recruit sufficient clinical sites and patients to participate in the NEW DAY Study; the NEW DAY Study may not meet favorable end points or otherwise establish ILUVIEN as a preferred first-line treatment, as well as the other factors discussed in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of (i) Alimera’s Annual Report on Form 10-K for the year ended December 31, 2019 and (ii) Alimera’s Quarterly Report on Form 10-Q for both the three months ended March 31, 2020 and June 30, 2020, which are on file with the Securities and Exchange Commission (SEC) and available on the SEC’s website at http://www.sec.gov. as well as Alimera’s website under Investor Relations.
The forward-looking statements in this press release speak only as of the date of this press release (unless another date is indicated). 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.
| For investor inquiries: For media inquiries: Scott Gordon Jules Abraham for Alimera Sciences for Alimera Sciences scottg@coreir.com julesa@coreir.com |
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