Alimera Announces Reimbursement of Uveitis Indication Granted for ILUVIEN® in Portugal
Alimera Sciences has received reimbursement approval without label restrictions for its ILUVIEN® (fluocinolone acetonide) implant in Portugal, as granted by INFARMED. The company plans to launch the product in Q3 2022, expanding its market presence in treating non-infectious uveitis affecting the posterior segment.
CEO Rick Eiswirth stated that this marks a significant step in making ILUVIEN accessible to patients across various markets, enhancing treatment options for chronic inflammatory conditions.
- Reimbursement approved with no restrictions for ILUVIEN in Portugal.
- Launch planned for Q3 2022, expanding availability in direct and distributor markets.
- Product aims to provide improved treatment for patients with non-infectious uveitis.
- None.
Reimbursement granted with no restrictions to the label
Alimera to begin selling later in Q3
ATLANTA, Aug. 09, 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 affecting the posterior segment in Portugal. Reimbursement was granted by the National Authority of Medicines and Health Products (INFARMED) with no change to the current label.
“This summer has been a productive one for expanding availability of our non-infectious uveitis indication in our International Segment with it soon to be accessible to patients in all of our direct markets in addition to our key distributor markets,” said Rick Eiswirth, President and Chief Executive Officer of Alimera. “We are looking forward to the third quarter launches in Portugal and France to make ILUVIEN available for patients suffering from this persistent inflammatory condition and give physicians in these countries a better tool to help their patients see better, longer, with fewer injections.”
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 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.
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 Portugal. 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 launch ILUVIEN in Portugal and France for non-infectious uveitis affecting the posterior segment, that ILUVIEN will help uveitis patients see better, longer with fewer injections, and the willingness of healthcare professionals and organizations in Portugal and France 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 |
FAQ
What reimbursement was granted to Alimera Sciences for ILUVIEN?
When will Alimera launch ILUVIEN in Portugal?
What is ILUVIEN used to treat?
Which regulatory body approved the reimbursement for ILUVIEN?
