Alimera Announces Approval and Pricing Granted for ILUVIEN® for Uveitis in Italy
Alimera Sciences announces the approval of ILUVIEN for treating non-infectious uveitis affecting the posterior segment in Italy, with pricing and reimbursement confirmed by the Italian Medicines Agency (AIFA). This new indication aims to reduce uveitis recurrence and is set to launch with distribution partner SIFI. ILUVIEN utilizes CONTINUOUS MICRODOSING™ technology, allowing sustained release for 36 months. The launch marks an expansion as Italy becomes the fifth market for ILUVIEN's new indication, enhancing patient care in managing this chronic eye condition.
- Approval of ILUVIEN for non-infectious posterior uveitis in Italy
- Positive pricing and reimbursement determination by AIFA
- Launch in Italy adds to existing markets, expanding revenue potential
- SIFI partnership for enhanced distribution in Italy
- None.
ILUVIEN receives approval and pricing for non-infectious uveitis affecting the posterior segment indication in July; launch to follow
ATLANTA, July 08, 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 received approval, including a positive determination for the pricing and reimbursement, for ILUVIEN for the prevention of relapse in recurrent non-infectious uveitis affecting the posterior segment of the eye from the Italian Medicines Agency, AIFA.
“With this new indication ILUVIEN will help us in significantly reducing rates of uveitis recurrence and increasing duration of recurrence-free time in our patients with non-infectious uveitis affecting the posterior segment,” said Elisabetta Miserocchi, Associate Professor at San Raffaele University, Milan, Italy.
Alimera will launch ILUVIEN® (fluocinolone acetonide intravitreal implant) 0.19 mg sustained release intravitreal implant behind its new uveitis indication in Italy, through its distribution partner, SIFI.
“This is excellent news as Italy will be our fifth market and the second launch this year for this ILUVIEN indication,” said Rick Eiswirth, President and Chief Executive Officer of Alimera. “We look forward to providing patients in Italy with non-infectious uveitis affecting the posterior segment with the ability to prevent the recurrence of their disease, enabling them to see better and longer with fewer injections.”
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. NIPU affects people of all ages, producing retinal 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, Alimera believes 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 invaluable to patients, physicians and partners concerned with retinal health and maintaining better vision longer. For more information, please visit www.alimerasciences.com.
About SIFI
SIFI is the leading Italian ophthalmic company, focused on eye care since 1935. SIFI concentrates its R&D and manufacturing in Italy exporting to more than 20 countries with a direct presence in Italy, Spain, France, Romania, Mexico and Turkey. Since June 2015, SIFI is backed by 21 Invest, a private equity firm, to support the company’s expansion strategy, based on establishing direct commercial operations in major European markets and expanding its network of international distributors. Headquartered in Catania, Sicily, SIFI has a staff of over approximately 400 people worldwide. For more information, please visit www.sifigroup.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 for the launch of ILUVIEN’s non-infectious posterior uveitis indication in Italy. 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, SIFI’s ability to launch ILUVIEN in Italy for non-infectious posterior uveitis, and the willingness of healthcare professionals and organizations in Italy 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 Report on Form 10-Q for the quarter ended March 31, 2022, which is 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
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