ATLANTA, Nov. 01, 2022 (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, announces that Alimera Sciences Europe Limited, its Ireland-based European subsidiary, has been granted reimbursement for ILUVIEN ® (fluocinolone acetonide intravitreal implant) 0.19 mg sustained release intravitreal implant for non-infectious uveitis, through its distribution partner, Medis Pharmaceutical Company. After the National Health Insurance Fund (NHIF) agreed to the unmet need and budget impact, the State Institute for Drug Control (SUKL) in the Czech Republic issued a positive decision that ILUVIEN is reimbursed for the prevention of the relapse in adult patients with recurrent non-infectious uveitis affecting the posterior segment of the eye.
“We are pleased to gain this reimbursement in the Czech Republic and thankful to our partner Medis for this achievement and for their upcoming launch,” said Rick Eiswirth, President and Chief Executive Officer of Alimera. “The positive assessment coming from SUKL and the recognition of this unmet need by the NHIF will help physicians in the Czech Republic prevent the relapse of recurrent non-infectious uveitis affecting the posterior segment.”
The ILUVIEN sustained release intravitreal implant is indicated in Europe for the treatment of vision impairment associated with chronic diabetic macular edema (DME) considered insufficiently responsive to available therapies and for prevention of relapse in recurrent non-infectious uveitis affecting the posterior segment of the eye (NIU-PS).
About ILUVIEN
The Company’s primary product ILUVIEN is a 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. The non-infectious uveitis affecting the posterior segment indication for ILUVIEN was launched in Germany and the U.K. in late 2019, Belgium in 2021 and Ireland, Spain, and Italy in 2022. ILUVIEN is not approved for treatment of uveitis in the United States.
About Non-Infectious Uveitis Affecting the Posterior Segment (NIU-PS)
It is a diverse group of non-infectious uveitic inflammatory conditions that can affect the posterior segment of the eye. NIU-PS can affect people of all ages, producing swelling and destroying eye tissues, which can lead to severe vision loss and blindness and is a leading cause of working age blindness in many countries. Patients with NIU-PS 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 may also 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 these inflammatory eye conditions.
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.
About Medis d.o.o.
Medis Pharmaceutical Company is a leading independent medical marketing company focused on commercialization of innovative pharmaceutical products, with emphasis on specialty drugs, medical equipment and self-care brands. Medis aims at making the most advanced and effective medical treatments accessible to every patient in the Central and Eastern Europe (CEE) region that represent up to 70 million potential customers. Its fully owned subsidiaries across the CEE region are leveraging its marketing know-how, scientific expertise and product knowledge. It is headquartered in Ljubljana, Slovenia, founded in 1989, and employs more than 350. Learn more about Medis at www.medis.health/en/
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 reimbursement of the ILUVIEN (fluocinolone acetonide intravitreal implant) 0.19 mg sustained release intravitreal implant for non-infectious uveitis affecting the posterior segment in the Czech Republic. 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, Medis’s ability to launch ILUVIEN in the Czech Republic for non-infectious uveitis affecting the posterior segment, that ILUVIEN will help prevent the relapse of recurrent non-infectious uveitis affecting the posterior segment, and the willingness of healthcare professionals and organizations in the Czech Republic to adopt ILUVIEN for this indication, 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, 2021 and the Quarterly Reports on Form 10-Q for the quarters ended March 31, 2022 and June 30, 2022, which are on file 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 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: Jules Abraham for Alimera Sciences 917-885-7378 julesa@coreir.com | For investor inquiries: Scott Gordon for Alimera Sciences scottg@coreir.com |
