- Significant number of U.K. patients with chronic diabetic macular edema achieved the level of vision required in the U.K. to legally drive a car
- At 24 months, 86.7% of these patients maintained or gained vision after receiving ILUVIEN® in routine clinical practice.
ATLANTA, July 25, 2017 (GLOBE NEWSWIRE) -- Alimera Sciences, Inc. (NASDAQ:ALIM) (Alimera), a leader in the commercialization and development of prescription ophthalmic pharmaceuticals, today announced that data from an ongoing audit of real-world U.K. clinical practice, published online July 18, 2017 in Eye, show a significant number of patients with chronic diabetic macular edema (DME) met the vision level requirement to drive after receiving a single ILUVIEN® implant. In the U.K., the Driver and Vehicle Licensing Agency requires a minimum of 6/12 (equivalent to 20/40) visual acuity to drive. The study data showed that at 24 months, the percentage of patients with 20/40 visual acuity increased from a baseline of 18.1% to 39.6% after receiving the ILUVIEN implant.
The data were collected on 345 eyes (305 patients) from the Medisoft™ electronic medical record data systems used in 14 U.K. centers. At the 24-month point, the data show 86.7% of patients maintained or gained visual acuity after receiving ILUVIEN in routine clinical practice. The mean visual acuity increased from 51.9 letters at baseline to 57.2 letters at 24 months, an average gain of 5.3 letters. Fifteen percent of the patients achieved a ≥15 letter improvement at 12 months, increasing to 20.8% of patients at 24 months.
These visual acuity outcomes were comparable to the ILUVIEN Phase III clinical trial (FAME) results at 24 months despite patients from this audit having had more prior intravitreal treatments and hence more chronic DME. In the FAME trials, all patients had received prior laser therapy, but few had received anti-vascular endothelial growth factor (anti-VEGF) therapies. However, in the Medisoft audit, 84.6% of treated eyes had received at least one prior intravitreal treatment with a mean of 7.36 prior intravitreal treatments administered.
Safety issues in the audit were also consistent with the FAME results. Emergent intraocular pressure (IOP) related events (defined as use of IOP-lowering medication, a change in IOP ≥10 mmHg from baseline and a rise in IOP >30mmHg, or IOP-lowering surgery) were consistent with those seen in FAME at a similar time-point, and within the known safety profile for intravitreal corticosteroids.
“Often real-world vision outcomes of clinical treatment with intravitreal anti-VEGF injections are lower than reported in clinical trials, as fewer injections are often given in real-world practice. Because one injection of ILUVIEN delivers a continuous microdose to the retina for up to three years, compliance and clinical capacity issues are reduced, and we have found that routine clinical practice achieves similar outcomes to the Phase III trials,” said Clare Bailey, Consultant Ophthalmologist from Bristol Eye Hospital, who is leading the Medisoft audit.
About the Medisoft Audit
The ongoing audit collects real-world data on routine clinical treatment of diabetic macular edema (DME) patients in the U.K. with 0.2µg / day dose of the corticosteroid fluocinolone acetonide (FAc). The data were collected at 14 U.K. clinical sites using the Medisoft electronic medical record data system, which is used by more than 80 National Health System trusts. To meet the requirement to be included in the audit, these patients must have had chronic DME considered insufficiently responsive to available therapies. Retrospective safety data, best-recorded visual acuity and a limited amount of data from optical coherence tomography have been gathered on 345 eyes (305 DME patients).
About ILUVIEN
In the European Union, ILUVIEN is indicated to treat vision impairment associated with chronic DME 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.
About Alimera Sciences, Inc.
Alimera, founded in June 2003, is a pharmaceutical company that specializes in the commercialization, research, 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. Alimera or its subsidiaries now operate directly in the U.S., U.K., Ireland, Germany, Austria and Portugal and through third party distribution agreements in Spain, Italy and the Middle East.
For more information, please visit www.alimerasciences.com.