Alimera Obtains Marketing Authorization for ILUVIEN® in Portugal for the Treatment of Non-Infectious Posterior Uveitis
Company continues strategy to grow the use of ILUVIEN internationally through geographic expansion and further penetration into existing markets
ATLANTA, Oct. 03, 2019 (GLOBE NEWSWIRE) -- Alimera Sciences, Inc. (Nasdaq: ALIM) (“Alimera”), a leader in the commercialization and development of prescription ophthalmology treatments for the management of retinal diseases, announces that INFARMED, the governmental agency that oversees the availability of medical products in Portugal, granted marketing authorization on October 1, 2019 for ILUVIEN® for the prevention of relapse in recurrent non-infectious uveitis affecting the posterior segment (NIPU).
Alimera will market the product directly to physicians in Portugal through its European sales organization. Alimera currently sells ILUVIEN in Portugal for the treatment of diabetic macular edema (DME). Once reimbursement for the new indication is granted, Alimera will begin marketing ILUVIEN in Portugal for NIPU as well.
“We expect the European rollout of ILUVIEN’s newly approved indication for the treatment of NIPU to be a growth driver of our business,” said Rick Eiswirth, president and CEO of Alimera. “We believe that having this second indication will continue to raise physician awareness as we have two indications in which to discuss ILUVIEN’s ability to help patients see better, longer with fewer injections. We look forward to providing updates on our launch of ILUVIEN for this new indication throughout Europe and other international territories.”
See www.ILUVIEN.com for important safety information.
About Non-Infectious Posterior Uveitis
Posterior segment non-infectious uveitis (NIPU) is a chronic, inflammatory disease affecting the posterior segment of the eye, often involving the retina, and is a leading cause of blindness in 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 NIPU are typically treated with systemic steroids, which are 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 also can have severe side effects, including an increased risk of cancer and infection. As a result, there remains a significant need for new therapies with improved efficacy, tolerability, and safety profiles to manage this disease.
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. 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, Czech Republic, the Netherlands, and Luxembourg. The regulatory process is now in the national phase in which the European member states have finalized or are expected to finalize the label for the new indication to meet each country’s local requirements. Timeline to this goal varies by each country. ILUVIEN is not approved for treatment of uveitis in the United States.
About Alimera Sciences, Inc.
Alimera, founded in June 2003, is a pharmaceutical company that specializes in the commercialization and development of prescription ophthalmic pharmaceuticals for the management of retinal diseases. 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. 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, regarding Alimera’s expectation that the European roll out of ILUVIEN’s newly approved indication for the treatment of NIPU will be a growth driver of Alimera’s business. 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, (a) whether physicians and patients will be receptive to using ILUVIEN for NIPU in Portugal and other countries as Alimera expects, (b) whether and when reimbursement for the new indication is granted in Portugal and other countries where Alimera is seeking and may seek to market ILUVIEN for NIPU, and (c) 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, 2018 and its Quarterly Report on Form 10-Q for the quarter ended June 30, 2019, which are on file with the Securities and Exchange Commission and available on its website at http://www.sec.gov.
|For press inquiries:
for Alimera Sciences
|For investor inquiries:
for Alimera Sciences