Positive consistent results spur move to cap study at 550 patients
Enrollment complete as of January 2017
ATLANTA, July 19, 2017 (GLOBE NEWSWIRE) -- Alimera Sciences, Inc. (NASDAQ:ALIM) (Alimera), a leader in the commercialization, research and development of prescription ophthalmic pharmaceuticals, today announced that the United Kingdom's Medicines and Healthcare Products Regulatory Agency (MHRA) has given final approval to reduce the size of its ILUVIEN Registry Safety Study (IRISS).
A post-marketing study, IRISS was originally designed to follow 800 ILUVIEN patients over five years. However, consistently positive real-world safety data from IRISS and other post-marketing studies led Alimera to seek a smaller sample size. Alimera enrolled the 550th patient in January of this year, making the anticipated last patient, last visit date January 2020.
"We are very pleased to receive final approval from MHRA to complete enrollment in IRISS as it stands today," said Dan Myers, CEO of Alimera. "Since the beginning, the results we've seen in our post-marketing studies have mirrored, and often exceeded, the results in our FAME™ clinical trials. From this, we concluded that we could potentially reduce the IRISS sample size without compromising on the study objective, and MHRA agreed. In addition to cost and time savings, our ability to produce data sets on safety, efficacy and disease burden reduction earlier than expected allows us to share this data with our customers."
About ILUVIEN
ILUVIEN (fluocinolone acetonide intravitreal implant) 0.19 mg is a sustained release intravitreal implant indicated in the E.U. to treat vision impairment associated with chronic DME considered insufficiently responsive to available therapies. Each ILUVIEN implant with its continuous microdosing is designed to release submicrogram levels of fluocinolone acetonide, a corticosteroid, for 36 months, enabling the physician to treat the disease consistently every day.
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.
About Alimera Sciences, Inc.
Alimera, founded in June 2003, is a pharmaceutical company that specializes in the commercialization, research, 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 will affect millions of people in our aging populations. Alimera’s commitment to retina specialists and their patients is manifest in Alimera’s product and development portfolio designed to treat early- and late-stage diseases. 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, the results of our post-marketing studies of ILUVIEN, the expected timing of the last patient visit for IRISS and the benefits to be realized from the reduced patient enrollment in IRISS. 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, but are not limited to, the ability of the reduced enrollment in IRISS to yield results consistent with the FAME™ clinical trials, our ability to capture the anticipated cost savings from the smaller sample size and our ability to accelerate the completion of IRISS, as well as other factors 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, 2016 and Quarterly Report on Form 10-Q for the quarter ended March 31, 2017, which are on file with the Securities and Exchange Commission (SEC) and available on the SEC’s website at www.sec.gov. Additional factors may be set forth in those sections of Alimera's Quarterly Report on Form 10-Q for the quarter ended June 30, 2017, to be filed in the third quarter of 2017 with the SEC. In addition to the risks described above and in Alimera’s Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the SEC, other unknown or unpredictable factors also could affect Alimera’s results. There can be no assurance that the actual results or developments anticipated by Alimera will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Alimera. Therefore, no assurance can be given that the outcomes stated in such forward-looking statements and estimates will be achieved.
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 too heavily on the forward-looking statements Alimera makes or that are made on its behalf. These forward-looking statements 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.