ATLANTA, Jan. 04, 2018 (GLOBE NEWSWIRE) -- Alimera Sciences, Inc. (NASDAQ:ALIM) (Alimera), a leader in the commercialization and development of prescription ophthalmic pharmaceuticals, today announced that it received validation of a Type II variation for ILUVIEN submitted on December 12, 2017. The Type II variation was submitted through the Mutual Recognition Procedure with the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom as the Reference Member State. The submission to the MHRA and sixteen European member states seeks to add the indication of recurrent and persistent non-infectious uveitis affecting the posterior segment (NIU-PS) to the ILUVIEN label in Europe. All seventeen bodies have accepted the submission. ILUVIEN is Alimera’s sustained release intravitreal implant currently indicated in Europe to treat vision impairment associated with chronic DME considered insufficiently responsive to available therapies.
“We are very pleased to have filed for this variation in 2017 ahead of schedule,” said Dan Myers, president and CEO of Alimera. “We are grateful to our partner pSivida for the support they have provided and we look forward to working with the regulatory authorities to make ILUVIEN available for uveitis patients in these 17 countries.”
Alimera submitted the results from two, randomized, double-masked, multi-center phase 3 clinical trials, with the primary endpoint at six months comparing the proportion of patients who do not experience a recurrence of NIU-PS. In both studies, the primary endpoint was met.
About Non-Infectious Posterior Uveitis
Posterior segment non-infectious uveitis is a chronic, inflammatory disease affecting the posterior segment of the eye, often involving the retina, which is a leading cause of blindness in the developed and developing countries. It affects people of all ages, producing swelling and destroying eye tissues, which can lead to severe vision loss and blindness. Patients with posterior uveitis are typically treated with systemic steroids, which are very effective but over time frequently lead to serious side effects, ranging from acne, weight gain, sleep and mood disorders to hypertension and osteoporosis that can limit effective dosing. Patients then often progress to steroid-sparing therapy with systemic immune suppressants or biologics, which themselves can have severe side effects, including an increased risk of cancer and infections.
One problem for patients and clinicians is that recurrence of uveitis is very common. In chronic uveitis, recurrence often occurs within six months of withholding treatment, and patients and clinicians are forced to go through cycles of treatment initiation and cessation with the accompanying complexity of managing several drug classes, and their side effects, at once.
For patients with recurring or chronic uveitis, locally delivered (intravitreal) steroids present an attractive treatment strategy, which allows for effective delivery of steroid at the point of need, while minimizing the risk of systemic side effects. ILUVIEN has been shown in clinical trials to significantly reduce the recurrence of non-infectious uveitis and accompanying vision loss, while at the same time reducing the need for systemic drug treatment.
ILUVIEN (fluocinolone acetonide intravitreal implant) 0.19 mg is a sustained release intravitreal implant indicated in Europe 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.
The seventeen countries reviewing the submission are the UK, Germany, France, Italy, Spain, Portugal, Ireland, Austria, Belgium, Denmark, Norway, Finland, Sweden, Poland, Czech Republic, the Netherlands and Luxembourg.
About Alimera Sciences, Inc.
Alimera, founded in June 2003, 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 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 availability of ILUVIEN to patients with uveitis in Europe. 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, Alimera’s ability to obtain regulatory approval in the various European countries of the uveitis indication for ILUVIEN, the willingness of physicians in those countries to accept ILUVIEN for use with their uveitis patients, 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 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 September 30, 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 Annual Report on Form 10-K for the year ended December 31, 2017, to be filed in the first quarter of 2018 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.
| For press inquiries: Katie Brazel for Alimera Sciences 404-317-8361 kbrazel@bellsouth.net | For investor inquiries: CG Capital for Alimera Sciences 877-889-1972 investorrelations@cg.capital |