ATLANTA, Feb. 07 11, 2022 (GLOBE NEWSWIRE) — Alimera Sciences, Inc. (Nasdaq: ALIM) (“Alimera”), a global pharmaceutical company whose mission is to be of invaluable value to patients, physicians and partners concerned with retinal health and maintain better vision for longer, announces that Alimera Sciences Europe Limited, its European subsidiary based in Ireland, will launch ILUVIEN® for non-infectious posterior uveitis in Spain, through its distribution partner, Brill Pharma (Brill). Brill has received a positive decision for the approval of the price and reimbursement of ILUVIEN for the prevention of relapses of recurrent non-infectious uveitis affecting the posterior segment of the eye from the Spanish Ministry of Health.
“We are excited to start 2022 with this launch in Spain, our third major market to add the posterior uveitis indication,” said Rick Eiswirth, President and CEO of Alimera. “ILUVIEN is the first and only treatment to deliver medication for up to thirty-six months, reducing the recurrence of disease symptoms and allowing patients to see better, longer with fewer injections.
ILUVIEN is an extended-release intravitreal implant indicated in Europe for the treatment of visual impairment associated with chronic diabetic macular edema (DME) considered insufficiently responsive to available therapies and for the prevention of relapses in recurrent non-infectious uveitis affecting the posterior segment of the eye ( NIPU).
The Company’s lead product is ILUVIEN (fluocinolone acetonide intravitreal implant) 0.19mg sustained release intravitreal implant, injected into the back of the eye. Using its CONTINUOUS MICRODOSING™ technology, ILUVIEN is designed to deliver sub-microgram levels of fluocinolone acetonide, a corticosteroid, for 36 months to reduce disease recurrence, allowing patients to maintain vision longer with fewer injections. ILUVIEN is approved in the United States, Canada, Kuwait, Lebanon and the United Arab Emirates for the treatment of diabetic macular edema (DME) in patients who have previously been treated with corticosteroids and who have not experienced clinically significant increase in intraocular pressure. In 17 European countries, ILUVIEN is indicated for the treatment of visual impairment associated with chronic DME considered insufficiently responsive to available therapies. In March 2019, ILUVIEN was approved in all 17 countries under the Mutual Recognition Procedure for the prevention of relapses of recurrent non-infectious uveitis affecting the posterior segment of the eye. The 17 European countries include UK, Germany, France, Italy, Spain, Portugal, Ireland, Austria, Belgium, Denmark, Norway, Finland, Sweden , Poland, the Czech Republic, the Netherlands and Luxembourg. The non-infectious posterior uveitis indication for ILUVIEN was launched in Germany and the UK in Q3 2019. ILUVIEN is not approved for the treatment of uveitis in the United States.
About Noninfectious Posterior Uveitis (NIPU)
Noninfectious posterior segment uveitis 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 tissue, which can lead to severe vision loss and blindness. Patients with NIPU are usually treated with systemic steroids, which are effective, but over time frequently lead to serious side effects, ranging from acne, weight gain, trouble sleeping and mood to hypertension and osteoporosis which may limit the effectiveness of the assay. Patients then often progress to steroid-sparing therapy with systemic immunosuppressants or biologics, which can also have serious side effects, including an increased risk of cancer and infection. Accordingly, there remains a significant need for new therapies with improved efficacy, tolerability, and safety profiles to manage this disease.
About Alimera Sciences, Inc.
Alimera Sciences is a global pharmaceutical company whose mission is to be of invaluable value to patients, physicians and partners concerned with retinal health and maintaining better vision, longer. For more information, please visit www.alimerasciences.com.
About Brill Pharma SL
Brill Pharma, the Spanish subsidiary of Bristol Laboratories UK, is based in Barcelona, Spain and was established in September 2012. It markets innovative products in ophthalmology, ranks second in this specific segment of the Spanish pharmaceutical market and has been recognized as fastest growing company. Spanish pharmaceutical company in its segment. The company employs more than 80 medical representatives covering Spain. For more details, please visit www.brillpharma.com.
This press release contains “forward-looking statements”, within the meaning of the Private Securities Litigation Reform Act of 1995, relating to, among other things, Alimera’s expectations regarding the price of ILUVIEN in Spain. These forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or modify any of them, and could cause actual results to differ materially from those projected. in its forward-looking statements. Significant factors that could cause actual results to differ include, but are not limited to, Brill’s ability to launch ILUVIEN in Spain for uveitis, and the willingness of healthcare professionals and organizations in Spain 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 fiscal year ended December 31, 2020 and quarterly reports on Form 10-Q for the quarters ended March 31, 2021, June 30, 2021 and September 30, 2021 which are filed 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 place undue reliance on any 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 disclaims any obligation, to publicly update or revise these forward-looking statements, whether as a result of new information, future events or otherwise.
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