Alimera Sciences Announces Data from 19 Iluvien(R) Studies to be Presented at 2018 ARVO

Alimera Sciences Announces Data from 19 Iluvien(R) Studies to be Presented at 2018 ARVO

Apr 24, 2018

ATLANTA, GA / ACCESSWIRE / April 24, 2018 / Alimera Sciences, Inc. (NASDAQ: ALIM) (Alimera), a leader in commercialization and development of prescription ophthalmic pharmaceuticals, today announced that data from 19 ILUVIEN pivotal and post-marketing studies have been accepted for presentation during the 2018 Annual Meeting of the Association for Research in Vision and Ophthalmology (ARVO) to be held Sunday, April 29 through Thursday, May 3 in Honolulu, Hawaii.

"At ARVO this year more real-world experience with ILUVIEN, including three-year outcomes, will be shared," said Dan Myers, CEO of Alimera. "Data from our two U.S. Phase 4 studies and other independent studies will be highlighted at the meeting. European studies will provide results after three years of clinical use in Germany and the United Kingdom. Studies from the U.S., Europe and the UAE will further demonstrate ILUVIEN safety and efficacy results."

The studies, listed below in alphabetical order by first author, are scheduled to be presented at ARVO on the following dates and times:

Sunday, April 29, 2018, from 1:00 p.m. to 2:45 p.m.

  • Best corrected visual acuity (BCVA) and central macular thickness (CMT) outcomes after fluocinolone acetonide intravitreal implant (FAc) injection in multi-treated chronic diabetic macular edema (DME) patients. Efficacy in a real-life setting in the United States, authored by Manuel Paez, Eric William Deupree, Michael John Tolentino, and Dana Madison Deupree.
  • Injectable 0.19 mg fluocinolone acetonide (FAc) intravitreal implant for the treatment of non-infectious uveitic macular edema - a retrospective case study analysis, authored by Ramin Khoramnia, Lea Weber, Stefanie Marx, Alexander Scheuerle, and Gerd Auffarth.

Monday, April 30, 2018, from 11:15 a.m. to 1:00 p.m.

  • Rapid structural and functional improvements following 0.19 mg fluocinolone acetonide (FAc) implant in diabetic macular edema patients with poor visual acuity: 6-month audit results from The United Arab Emirates, authored by Ahmed Elbarky.
  • Retinal nerve fiber layer thickness changes after intravitreal fluocinolone acetonide implant for chronic diabetic macular edema, authored by Manuel Falcao, Marta Inês Silva, Tânia Carolina Madeira, Vitor Adriano Fernandes, Vitor Rosas, Flávio Alves, and Fernando Falcao-Reis.
  • United Kingdom multicenter Medisoft™ electronic medical record real-world audit following implant of ILUVIEN® (fluocinolone acetonide 190 µg) - the first 3-year results from the UK, authored by Fahd Quhill, Clare Bailey, Usha Chakravarthy, Andrew Lotery, Geeta Menon, and James S. Talks.
  • Second-Line Treatment with ILUVIEN for persistent pre-treated Diabetic Macular Edema, authored by Michael Ulbig, Klaus Wehrmann, and Mathias Maier.

Wednesday, May 2, 2018, from 11:15 a.m. to 1:00 p.m.

  • Three-year outcome of fluocinolone acetonide intravitreal implant (ILUVIEN) in the treatment of chronic diabetic macular oedema: real-world results in the UK, authored by Fadi Alfaqawi, Ambreen Sarmad, Peck-Lin Lip, Samer Elsherbiny, Randhir Chavan, Arijit Mitra, and Bushra Mushtaq.
  • Retro-IDEAL study - results from real-world practice show that after substantial amounts of prior treatment with anti-VEGF and other therapies, a single ILUVIEN (fluocinolone acetonide; FAc) implant leads to sustained improvements lasting up to 36 months, authored by Albert Augustin.
  • Fluocinolone Acetonide (0.19 mcg/day) Intravitreal Implant and Improved Treatment Burden for Patients with Diabetic Macular Edema (DME), by Matthew Byun, Christopher D. Riemann, James Osher, and Yogin Patel.
  • Reduction in treatment burden and edema in patients with diabetic macula edema following 0.2 mg/day fluocinolone acetonide implant, authored by Clinton Ellingson, John William Kitchens, and Thomas W. Stone.
  • Optimization of diabetic macular edema (DME) therapy following 0.2 µg/day fluocinolone acetonide (FAc) implant administration, authored by Victor H. Gonzalez.
  • Real-life outcomes from the use of ILUVIEN in the treatment of refractory DMO, authored by Eleni Karatsai, Simon Taylor, and Katherine Atkins.
  • Prior steroid response as a predictor of real-world IOP safety with 0.2 µg/day fluocinolone acetonide (FAc) in diabetic macular edema (DME) therapy, authored by James C. Lai.
  • Fluocinolone acetonide (FAc) 0.2 mg intravitreal implant in the treatment of diabetic macular edema (DME), authored by John Liu, Joseph Coney, Jerome Schartman, David G. Miller, Hernando Zegarra, and Llewelyn Rao.
  • Real world data on the efficacy of Fluocinolone Acetonide (ILUVIEN) in eyes with diabetic macular oedema, authored by Haifa A. Madi, Yanmei Chen, David Steel, Jonathan Smith, Teresa Sandinha, and Maged S. Habib.
  • 36-months real-world experience in patients with refractory chronic diabetic macular edema (DME) treated with the 190 micrograms fluocinolone acetonide intravitreal implant (ILUVIEN), authored by Christine Anggun Putri, and Fahd Quhill.
  • Treatment burden associated with intravitreal injections in the real world: PALADIN Phase 4 trial with fluocinolone acetonide 0.2 µg/day, authored by Michael Singer.
  • Fluocinolone acetonide for persisting diabetic macular edema in routine clinical practice in the US. Long-term follow up, authored by Ana M. Suelves, Dominic Buzzacco, Louis Chorich III, and Sugat Patel.



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 edema, 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

For investor inquiries:

CG Capital
for Alimera Sciences

SOURCE: Alimera Sciences, Inc.