Alimera Announces Pricing and Reimbursement of Uveitis Indication Granted for ILUVIEN® in France
Alimera Sciences announces the upcoming launch of ILUVIEN in France for treating non-infectious posterior uveitis, partnering with Horus Pharma. This product, which recently received pricing and reimbursement approval, aims to reduce disease recurrence. ILUVIEN is already successful in treating diabetic macular edema and is now expanding to address uveitis, a leading cause of blindness. This launch marks a significant achievement in the company’s European strategy, expanding its market presence in major countries.
- Launch of ILUVIEN for non-infectious posterior uveitis in France enhances market presence.
- Horus Pharma's success in France contributes to expected demand for ILUVIEN.
- ILUVIEN is already established in multiple European countries for treating diabetic macular edema.
- Dependence on Horus Pharma's successful launch and acceptance of ILUVIEN in France.
- Potential risks associated with forward-looking statements regarding product performance.
Partner Horus Pharma to launch ILUVIEN for non-infectious uveitis affecting the posterior segment indication later in Q3
ATLANTA, July 22, 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 France, through its distribution partner, Horus Pharma S.A.S. (Horus). Horus has been granted pricing and reimbursement approval for ILUVIEN for prevention of relapse in recurrent non-infectious uveitis affecting the posterior segment of the eye from the Economics Committee for Health Products, CEPS.
“With France, we have now expanded the posterior uveitis indication to the largest western European countries as planned,” said Rick Eiswirth, President and Chief Executive Officer of Alimera. “Horus Pharma has grown France into the second largest ILUVIEN market for DME, based on demand, so we are now excited to see them launch behind this new indication, bringing reduced recurrence of this disease to many French patients.”
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 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 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 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 Horus Pharma S.A.S.
Founded in 2003, Horus Pharma is an independent French laboratory specialized in ophthalmology. Horus Pharma develops, patents and markets products designed to facilitate eye and eyelid healthcare. Horus Pharma operates in most segments related to ophthalmology and develops practical innovations that combine efficacy and safety. Focused on patient safety, our laboratory has developed recognized expertise in the development of preservative-free formulations and product delivery systems. For further details, please visit www.horus-pharma.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 and reimbursement of the ILUVIEN (fluocinolone acetonide intravitreal implant) 0.19 mg sustained release intravitreal implant for uveitis in France. 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, Horus’s ability to launch ILUVIEN in France for uveitis, the expectation that this launch will be successful like the DME launch, that ILUVIEN will bring reduced recurrence of this disease to many French patients, and the willingness of healthcare professionals and organizations in 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 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: | For investor inquiries: | |
| Jules Abraham | Scott Gordon | |
| for Alimera Sciences | for Alimera Sciences | |
| 917-885-7378 | scottg@coreir.com | |
| julesa@coreir.com |
FAQ
What is ILUVIEN and its purpose for patients in France?
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What company is partnering with Alimera Sciences for the ILUVIEN launch?
What approval did ILUVIEN receive before its launch?
How does ILUVIEN differ from current treatments for uveitis?
