ATLANTA, May 01, 2017 (GLOBE NEWSWIRE) -- Alimera Sciences, Inc. (NASDAQ: ALIM ) (Alimera), a leader in commercialization and development of prescription ophthalmic pharmaceuticals, today announced that data from 25 ILUVIEN pivotal and post-marketing studies and two presentations on diabetic retinopathy have been accepted for presentation during the 2017 Annual Meeting of the Association for Research in Vision and Ophthalmology (ARVO) to be held May 7 through 11 in Baltimore, Md.
"We are particularly excited about the ILUVIEN data being presented this year at ARVO," said Dan Myers, CEO of Alimera. "For the first time, not only will additional positive European real world data be highlighted, but other highlights include the first presentations of data from U.S. studies in a broad range of categories, including IOP safety data, data on the reduction in treatment burden, as well as data on ILUVIEN's impact on the progression of diabetic retinopathy."
The studies, listed below in alphabetical order by first author, are scheduled to be presented at ARVO on the following dates and times:
Sunday, May 7, 2017, from 8:30 a.m. to 10:15 a.m.
- One-Year Safety Outcomes of Intravitreal Implant of Fluocinolone Acetonide 0.19 Mg in Clinical Practice Assessed by Intraocular Pressure Measurement, authored by António Figueiredo, José António Dias, Carlos Marques-Neves, Rufino Silva, and Angelina Meireles.
- Real-Life Visual and Anatomical Outcomes with Fluocinolone Acetonide (Fac) and Cumulative Cost of Treatment in the Treatment of Chronic Diabetic Macular Edema (DME), authored by Rita Gonçalves, Pedro Coelho, Carla Teixeira, Rui Carvalho, Bruna Vieira, and Tiago Maio.
- Switching Corticosteroids Therapy for Diabetic Macular Edema, authored by Carlos Marques-Neves, João Paulo Castro e Sousa, David Martins, António Sampaio, and Paulo Kaku.
- Efficacy and Safety of Fluocinolone Acetonide Implant Use for the Treatment of Refractory Diabetic Macular Oedema and Its Impact on the Hospital Diabetic Eye Services, authored by Anastasios Sepetis and Spyridon Mourtzoukos.
Sunday May 7, 2017, from 3:15 p.m. to 5:00 p.m.
- Intravitreal Fluocinolone Acetonide and Intraocular Pressure: 1 Year of Follow-up in a Clinical Setting, authored by Ana Carolina C. Abreu, João Coelho, Bernardete Pessoa, Maria João Menéres, and Angelina Meireles.
- The First European Report of Real-Life Clinical Outcomes after 3 Years of Treatment with ILUVIEN ® (Fluocinolone Acetonide) in Patients with Chronic Diabetic Macular Edema (DME), authored by Albert J. Augustin and Jenny Atorf.
- ICE-UK - The Evaluation of the Fluocinolone Acetonide Intravitreal Implant for the Treatment of Chronic Diabetic Macular Edema (DME) in NHS Clinical Practice, authored by Daniela Collins.
- Early Versus Long-Term Changes in Visual Acuity (VA) with Continuous 0.2 µg/Day Fluocinolone Acetonide (Fac) Microdosing, authored by Vishak J. John.
- Efficacy and Safety Outcomes Following the Use of Fluocinolone Acetonide – An Ongoing Prospective Clinical Study, authored by Ramin Khoramnia, Karolina Ceglowska, Joanna Wasiak, Ivanka Dacheva, Katharina Linz, Tamer Tandogan, Saadettin Sel, Fritz Hengerer, and Gerd Auffarth.
- Early Central Subfield Thickness and Long-Term Visual Acuity Changes with Fluocinolone Acetonide (Fac)-Associated Continuous Microdosing in Diabetic Macular Edema, authored by Caesar Luo.
- Initial Efficacy, Anatomic and Safety Outcomes after Fluocinolone Acetonide 0.2 µg/Day Implant in Patients with DME: The PALADIN Real-World Observational Study, authored by Sam Mansour.
- Real-Life Efficacy with ILUVIEN ® (Fluocinolone Acetonide [Fac]) in Diabetic Macular Edema (DME) Patients in 4 Portuguese Ophthalmology Units, authored by Angelina Meireles, Bernardete Pessoa, João Coelho, Carla Teixeira, Manuel Alberto Falcão, Rita Gonçalves, Marta Ines Silva, and João Paulo Castro e Sousa.
- The CONSTANT Study: Area-Under-The-Curve (AUC) Analysis Comparing Fluocinolone Acetonide 0.2µg/Day (ILUVIEN ® ) Implant with Ranibizumab Plus Deferred Laser Over a 36-Month Study Period, authored by Daniel M. Miller.
- Selective Laser Trabeculoplasty (SLT) for the Reduction of Elevated Intraocular Pressure (IOP) Associated with Fluocinolone Acetonide (Fac) Intravitreal Implants, authored by Nathan M. Radcliffe.
- Clinical Outcomes in Treatment of Diabetic Macular Edema with Fluocinolone Acetonide Intravitreal Implant, authored by Matthew West, Samuel Kim and Aziz Khanifar.
- Treatment of Refractory Diabetic Macular Edema with Intravitreal Injection of a Fluocinolone Acetonide Implant by Shaina M. Rubino, Chris B. Komanski, and Vishak J. John.
- One-Year Follow Up Results of Fluocinolone Acetonide Intravitreal Implant for Diabetic Macular Edema (DME) in Highly Treated Eyes by Nisha Dhawlikar, Sumit P. Shah, David L. Yarian, Jonathan Prenner, Eric S. Friedman, H. M. Wheatley, Howard F. Fine, Dimosthenis Mantopoulos, and Daniel B. Roth.
Monday, May 8, 2017, 11:00 a.m. to 12:45 p.m.
- The Use of Fluocinolone Acetonide Implant (ILUVIEN) in Patients with Diabetic Macular Edema (DME) Previously Treated with Dexamethasone Intravitreal Implant (OZURDEX) – Efficacy and Safety Outcomes from Clinical Practice in Glasgow, Scotland, authored by Sridevi Rajasekaran, Umaima Mulla, Suzannah Drummond, Mike Gavin, and William Wykes.
Tuesday, May 9, 2017, 8:30 a.m. to 10:15 a.m.
- Efficacy and Safety Outcomes Following the Use of ILUVIEN in Vitrectomized Eyes – Results from the University Eye Clinic Frankfurt In Germany, authored by Frank H. Koch, Pankaj Singh, Adonis Chedid, Michael Mueller, Thomas Kohnen, and Svenja K. Deuchler.
- The Use of Intravitreal Implant ILUVIEN ® (Fluocinolone Acetonide) after Prior OZURDEX ® Implant (DEX) (Dexamethasone) in Patients with Diabetic Macular Edema (DME) - Efficacy and Safety Outcomes from the University Eye Clinic in Frankfurt, Germany, authored by Pankaj Singh, Adonis Chedid, Svenja Deuchler, Thomas Kohnen, Michael Mueller, and Frank H. Koch.
Tuesday, May 9, 2017, 11:00 a.m. to 12:45 p.m.
- Progression of Diabetic Retinopathy in Patients Treated with 0.2 Μg/Day Fluocinolone Acetonide (Fac) Implants for Diabetic Macular Edema (DME): A Fellow Eye-Controlled Analysis, authored by Raymond Iezzi, Barry Kapik, and Ken E. Green.
- Continuous Submicrogram Fluocinolone Acetonide (Fac) Therapy for the Treatment of Diabetic Retinopathy, authored by Charles C. Wykoff.
Wednesday, May 10, 2017, 11:00 a.m. to 12:45 p.m.
- UK Multi-Centre Medisoft EMR Audit of Intra-Operative Pressure Event Following Implant of ILUVIEN ® (Fluocinolone Acetonide 190 Μg), authored by Fahd Quhill, Clare Bailey, Usha Chakravarthy, Andrew J. Lotery, Geeta Menon, and James Talks.
- The Impact of Prior Steroid Therapy on Safety Outcomes Following Treatment with ILUVIEN (Fluocinolone Acetonide) – An Analysis of Intra-Ocular Outcomes (IOP) from UK Electronic Medical Records, authored by Serena Salvatore, Clare Bailey, Usha Chakravarthy, Andrew J. Lotery, Geeta Menon, and James Talks.
Wednesday, May 10, 2017, 3:45 p.m. to 5:30 p.m.
- Safety and Efficacy of Fluocinolone Acetonide Intravitreal Implant (Iluvien ® ) in Patients with Chronic Diabetic Macular Edema in a Real-Life Setting, authored by Monica Santos, António Campos, Arminda Neves, Pedro Alfaiate, Joana Pereira, and João Paulo Castro e Sousa.
Thursday, May 11, 2017, 8:30 a.m. to 10:15 a.m.
- Differential Effect of Corticosteroids on Müller Glial Cells, authored by Audrey Giocanti Auregan, Lourdes Siqueiros-Marquez, Hugo Charles-Messance, Romain Bénard, Cecilia Montañez, José Alain sahel, Florian Sennlaub, Xavier Guilloneau, Bahram Bodaghi, Ramin Tadayoni, and Alvaro Rendon.
Thursday, May 11, 2017, 11:30 a.m. to 1:15 p.m.
- Fluocinolone Acetonide (Fac): Pharmacokinetics and Clinical Relevance, authored by David Eichenbaum.
About ILUVIEN
ILUVIEN'S U.S. Indication
ILUVIEN (fluocinolone acetonide intravitreal implant) 0.19 mg is a sustained release intravitreal implant approved in the U.S. to treat diabetic macular edema in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure. Each ILUVIEN implant is designed to release submicrogram levels of fluocinolone acetonide, a corticosteroid, for 36 months.
ILUVIEN'S E.U. Indication
ILUVIEN is indicated for the treatment of vision impairment associated with chronic diabetic macular oedema, considered insufficiently responsive to available therapies.
About Diabetic Macular Edema (DME)
DME, the primary cause of vision loss associated with diabetic retinopathy, is a disease affecting the macula, the part of the retina responsible for central vision. When the blood vessel leakage associated with diabetic retinopathy results in swelling of the macula, the condition is called DME. The onset of DME is painless and may go unreported by the patient until it manifests with the blurring of central vision or acute vision loss. The severity of this blurring may range from mild to profound loss of vision. The Wisconsin Epidemiologic Study of Diabetic Retinopathy found that over a 10-year period approximately 19% of people with diabetes included in the study were diagnosed with DME. All people with type 1 or type 2 diabetes are at risk of developing DME. As the population of people with diabetes increases, Alimera expects the annual incidence of diagnosed DME to increase, as well.
In the United Kingdom and parts of Europe, diabetic macular edema is instead referred to as diabetic macular oedema or DMO.
About Alimera Sciences, Inc.
Alimera, founded in June 2003, is a pharmaceutical company that specializes in the commercialization and development of prescription ophthalmic pharmaceuticals. 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. Alimera’s commitment to retina specialists and their patients is manifest in Alimera’s product and development portfolio designed to treat early- and late-stage diseases. For more information, please visit www.alimerasciences.com .
For press inquiries: Katie Brazel for Alimera Sciences 404-317-8361 kbrazel@bellsouth.net For investor inquiries: CG Capital for Alimera Sciences 877-889-1972 investorrelations@cg.capital
