Alimera Sciences Announces Launch of ILUVIEN® for Uveitis in Spain
Alimera Sciences announced the pricing approval for ILUVIEN for the treatment of non-infectious posterior uveitis in Spain, marking its third major market for this indication. The approval allows Brill Pharma to launch ILUVIEN, a sustained release intravitreal implant designed to reduce symptoms for up to 36 months. With this launch, ILUVIEN continues to establish its presence in Europe, following previous approvals in Germany and the U.K. Alimera aims to enhance patient care in retinal health, addressing a significant need for effective treatments for chronic inflammatory eye diseases.
- ILUVIEN launch in Spain enhances market presence in Europe.
- Approval for pricing and reimbursement increases potential revenue from the NIPU indication.
- ILUVIEN's unique sustained release technology offers long-term symptom relief.
- Dependence on Brill Pharma's capability to successfully launch ILUVIEN in Spain.
- Market risks associated with adoption rates among healthcare professionals in Spain.
ILUVIEN received pricing approval for non-infectious posterior uveitis indication in December
ATLANTA, Feb. 07, 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, will launch ILUVIEN® for non-infectious posterior uveitis in Spain, through its distribution partner, Brill Pharma (Brill). Brill has received a positive resolution for the pricing and reimbursement approval for ILUVIEN for prevention of relapse in recurrent non-infectious uveitis affecting the posterior segment of the eye from the Spanish Ministry of Health.
“We are pleased to begin 2022 with this launch in Spain, our third major market to add the posterior uveitis indication,” said Rick Eiswirth, President and Chief Executive Officer of Alimera. “ILUVIEN is the first and only treatment to deliver drug for up to thirty-six months, reducing the recurrence of symptoms of disease, and enabling patients to see better, longer with fewer injections.”
ILUVIEN is a sustained release intravitreal implant 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 (NIPU).
About ILUVIEN
The Company’s primary product is ILUVIEN (fluocinolone acetonide intravitreal implant) 0.19 mg 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 posterior uveitis indication for ILUVIEN was launched in Germany and the U.K. in 3Q 2019. ILUVIEN is not approved for treatment of uveitis in the United States.
About Non-Infectious Posterior Uveitis (NIPU)
Posterior segment non-infectious 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 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.
About Alimera Sciences, Inc.
Alimera Sciences 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 Brill Pharma S.L
Brill Pharma, the Spanish subsidiary of Bristol Laboratories U.K., is based in Barcelona, Spain and was established in September 2012. It markets innovative products in ophthalmology, is ranked second in this specific segment of the Spanish pharma market and was recognized as the fastest growing Spanish pharma company in its segment. The company employs more than 80 medical representatives covering Spain. For further details, please visit www.brillpharma.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, Alimera’s expectations with respect to pricing of ILUVIEN in Spain. 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, 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 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 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 |
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