wow wowzer read peter/\Alimera Sciences (ALIM) Announces Regulatory Approval for ILUVIEN in Benelux Countries for Treatment of Non-Infectious Posterior Uveitis
Alimera Sciences, Inc. (Nasdaq: ALIM) (“Alimera”), a leader in the commercialization and development of prescription ophthalmology treatments for the management of retinal diseases, announces that the governmental agencies that oversee the availability of medical products in Belgium, The Netherlands and Luxembourg, collectively known as the Benelux countries, have each granted marketing authorization for ILUVIEN® for prevention of relapse in recurrent non-infectious uveitis affecting the posterior segment of the eye.
The complete Benelux approval was achieved when The Netherlands’ Medicines Evaluation Board informed Alimera of their approval on November 6, 2019. The approval by Belgium’s Federal Agency for Medicines and Health Products was received in May of 2019, and Luxembourg’s Heads of Medicines Agencies provided its confirmation of regulatory approval in late October. Alimera announced in September that it was expanding its relationship with French distribution partner, Horus Pharmaceuticals, who will help the Company achieve reimbursement in all three countries, after which it will oversee distribution throughout Benelux for the new indication.
“We are pleased to now have the approvals for this new indication for ILUVIEN across Benelux so that our partner, Horus Pharmaceuticals, can now pursue reimbursement in each of these markets for both diabetic macular edema and posterior segment non-infectious uveitis,” said Rick Eiswirth, president and CEO of Alimera.
“Following a strong launch in France for diabetic macular edema, we are excited to see what Horus can do with ILUVIEN in these countries, providing us with additional markets in Europe where we believe ILUVIEN can help physicians control the recurrence of disease in patients who have either of these conditions.”
COULD BE HUGE, BUYOUT COMING ????? Alimera Sciences to Participate in the LD Micro 12th Annual Main Event on December 10, 2019 GlobeNewswire Inc. - 12/4/2019 8:30:10 AM
Alimera Sciences to Participate in the LD Micro 12th Annual Main Event on December 10, 2019 Date : 12/04/2019 @ 8:30AM Source : GlobeNewswire Inc. Stock : Alimera Sciences Inc (ALIM) Quote : 9.1 1.58 (21.01%) @ 5:19PM Alimera Sciences to Participate in the LD Micro 12th Annual Main Event on December 10, 2019
Alimera Sciences, Inc. (Nasdaq: ALIM) (“Alimera” or “Company”), a leader in the commercialization and development of prescription ophthalmology treatments for the management of retinal diseases, today announces that Rick Eiswirth, President and Chief Executive Officer of Alimera, will be a featured presenter at the LD Micro Main Event on Tuesday, December 10, 2019 at 12:40 PM Pacific Time at the Luxe Sunset Boulevard Hotel in Los Angeles, CA. Mr. Eiswirth will provide an overview of the company’s business model and growth strategy and will be available for one-on-one meetings. In addition, his presentation will be webcast. To access the webcast, please visit http://wsw.com/ldmicro17/alim at the time of the presentation. The webcast will also be archived for 90 days and may be subsequently accessed on the Company’s website. For those interested in attending or for registered attendees who wish to request meetings, please contact David Scher at david@ldmicro.com or visit www.ldmicro.com for more information.
About Alimera Sciences, Inc.
Alimera, founded in June 2003, is a pharmaceutical company that specializes in the commercialization and development of prescription ophthalmic pharmaceuticals for the management of retinal diseases. Alimera is presently focused on diseases affecting the back of the eye, or retina, because these diseases are not well treated with current therapies and will affect millions of people in our aging populations. For more information, please visit www.alimerasciences.com.
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, Czech Republic, the Netherlands, and Luxembourg. The regulatory process is now in the national phase in which the European member states have finalized or are expected to finalize the label for the new indication to meet each country’s local requirements. Timeline to this goal varies by each country, and 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.
For press inquiries: For investor inquiries: Jules Abraham Scott Gordon for Alimera Sciences for Alimera Sciences 917-885-7378 scottg@coreir.com
ALIM surprises on Earnings. Gapping higher in the morning.
ALIM reported 2nd qtr 2020 earnings of $-0.51 per share on 7/29/20. This beat the $-1.62 consensus of the 2 analysts covering the company. Surprise %: 68.4%
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