Alimera Announces Submission of Marketing Authorization Application in Switzerland for ILUVIEN®
Alimera Sciences has announced the filing of a marketing authorization application in Switzerland for ILUVIEN®, a treatment for diabetic macular edema (DME), through its distribution partner Horus Pharma S.A.S. This marks a significant step in Alimera's geographic expansion efforts in Europe.
ILUVIEN is currently approved in 17 European countries and is also indicated in the U.S., Kuwait, and the U.A.E. The Swiss application seeks approval consistent with U.S. labeling, targeting patients previously treated with corticosteroids who have not experienced significant intraocular pressure increases.
- Filing of ILUVIEN® marketing authorization application in Switzerland expands market opportunities.
- Partnership with Horus Pharma has a successful track record in European markets.
- ILUVIEN is already approved in 17 European countries, showing existing market acceptance.
- None.
Switzerland is latest market for Alimera in continued geographic expansion
ATLANTA, Feb. 22, 2023 (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 its distribution partner, Horus Pharma S.A.S. (Horus) through its Swiss affiliate Horus Pharma Suisse SA, has filed a marketing authorization application dossier for ILUVIEN® for diabetic macular edema (DME) with the Swiss Agency for Therapeutic Products (Swissmedic).
“In our continued efforts for expanding our distribution, the partnership with Horus in Switzerland takes this critical first step toward an approval there,” said Rick Eiswirth, President and Chief Executive Officer of Alimera. “Horus Pharma has been a close partner for us, with proven success selling ILUVIEN in other European markets, and has worked very quickly with our team to develop this dossier.”
Claude Claret, CEO of Horus added, “Our teams are delighted to develop and expand their collaboration with Alimera. The good results recorded are the result of this daily partnership.”
The Swiss application seeks an indication consistent with the U.S. approved labeling, with the proposed wording “Treatment of 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.” ILUVIEN is currently indicated in 17 European countries 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.
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., 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. ILUVIEN is marketed for the non-infectious posterior uveitis indication in Germany, France, the U.K., the Netherlands, Portugal, Spain, Austria, Ireland and Italy. ILUVIEN is not approved for treatment of uveitis in the United States.
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 the opportunity for Horus to obtain marketing approval for ILUVIEN in Switzerland with a suitable indication for use and the likelihood of success for ILUVIEN in that market. 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. Other factors are 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 quarters ended March 31, 2022, June 30, 2022, and September 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
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