Alimera Sciences Announces Data From 27 ILUVIEN® Studies to Be Presented at 2017 ARVO
May 01 2017 - 7:30AM
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
www.ILUVIEN.com.
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.
www.alimerasciences.com
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
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