Data highlight ILUVIEN’s advantages as the only therapy that consistently treats diabetic macular edema (DME) for up to 3 years
ATLANTA, Oct. 01, 2019 (GLOBE NEWSWIRE) -- Alimera Sciences, Inc. (ALIM) (Alimera), a leader in the commercialization and development of prescription ophthalmology treatments for the management of retinal diseases, announces that clinical data for ILUVIEN® (fluocinolone acetonide intravitreal implant 0.19mg) will be featured in multiple papers and discussions at the Annual Meeting of the American Academy of Ophthalmology, taking place at the Moscone Center in San Francisco from October 12-15, 2019.
Five ePosters featuring long-term clinical efficacy and safety data for ILUVIEN will be available for viewing at the conference, with three having subsequent discussion sessions following their initial availability.
“We are pleased to once again showcase the differentiated benefits of ILUVIEN for the treatment of DME in several new clinical papers and discussions at this year’s AAO conference,” said Rick Eiswirth, CEO of Alimera. “There continues to be a high level of interest from U.S. and international investigators to learn more about ILUVIEN and the therapy’s ability to control the recurrence of DME by continuously and consistently treating the disease for up to three years. We continue to invest in generating additional clinical data and real-world experience studies from the more than 20,000 ILUVIEN injections to date, and plan to share additional data at future ophthalmology conferences.”
Details for the posters and discussions are as follows:
Poster Number: PO412
Title: “Global Safety Update: Long Term IOP Outcomes in Patients Receiving the 0.2 ug/day Fluocinolone Acetonide (ILUVIEN) intravitreal implant”
Author: Caesar Luo, Bay Area Retina Associates
Discussion Topic/Date/Time: Retina, Vitreous; Saturday, October 12, 2019; 12:45 PM PT
Poster Number: PD27
Title: “Fluocinolone acetonide (Fac) intravitreal implant for refractory DME: 3 years and beyond”
Author: Anastasios Sepetis, University Hospital, Southampton, NHS, UK
Discussion Topic/Date/Time: Retina, Vitreous; Sunday, October 13, 2019; 12:45 PM PT
Poster Number: PO418
Title: “Switching Therapy for Refractory DME: Twelve- and 24-Month Results with Fluocinolone Intravitreal Implant”
Author: Argyrios Chronopoulos, Universite de Geneve, Germany
Discussion Topic/Date/Time: Retina, Vitreous; Monday, October 14, 2019; 12:00 PM PT
Remaining ePosters, which may be accessed during the entire meeting, include:
PO458: “Outcomes achieved with the intravitreal 0.19 mg fluocinolone acetonide implant – results from the German perspective IDEAL registry study”
Author: Ramin Khoramnia, Universtat Heidelberg, Germany
PO472: “Timing and Treatment Considerations for Reimplantation with 0.19-mg Fluocinolone Acetonide (ILUVIEN) implant”
Author: Matthew Manry, Eye Center of Northern Colorado
For those interested in attending or accessing the presentations, the conference program is available at https://www.aao.org/annual-meeting/program-highlights/program-highlights-2.
About The American Academy of Ophthalmology
The American Academy of Ophthalmology (AAO) is the world’s largest association of eye physicians and surgeons. A global community of 32,000 medical doctors, the AAO protects sight and empowers lives by setting the standards for ophthalmic education and advocating for its patients and the public. The AAO innovates to advance the ophthalmology profession and works to ensure delivery of the highest-quality eye care.
ILUVIEN (fluocinolone acetonide intravitreal implant) 0.19 mg is a sustained release intravitreal implant, injected into the back of the eye. With its CONTINUOUS MICRODOSINGTM technology, ILUVIEN is designed to release submicrogram levels of fluocinolone acetonide, a corticosteroid, for up to 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 same 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. ILUVIEN is not approved for treatment of uveitis in the United States.
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.
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, that Alimera will continue to invest in generating additional clinical data and real-world experience studies from the more than 20,000 ILUVIEN injections to date, and that Alimera will plan to share additional data at future ophthalmology conferences. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change these expectations, and could cause actual results to differ materially from those projected in these forward-looking statements. Meaningful factors that could cause actual results to differ include, but are not limited to, 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, 2018, which is on file with the Securities and Exchange Commission and available on its website at http://www.sec.gov.
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