Alimera Reports Safety and Efficacy Results From the 18-Month Interim Readout of the Human PK Iluvien(R) Study
ATLANTA, Sept. 29 /PRNewswire/ -- Alimera Sciences, Inc., a privately held biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, today reported the interim 18-month safety and efficacy results from the first human pharmacokinetic study (PK Study) of Iluvien®.
This 36-month, open-label, Phase 2 study, running concurrently with the pivotal Phase 3 FAME(TM) Study (Fluocinolone Acetonide in Diabetic Macular Edema), is designed primarily to assess systemic exposure of the corticosteroid, fluocinolone acetonide (FA), after administration of Iluvien in patients with DME. Secondarily, the PK Study is designed to provide information on the safety and efficacy of Iluvien in a DME patient population. A total of 37 subjects were enrolled in the PK Study, 20 patients on the low dose of Iluvien (an approximate 0.23 micrograms per day dose), and 17 patients on the high dose of Iluvien (an approximate 0.45 micrograms per day dose).
In the 18-month interim readout, data from the subgroup of patients that reflect the same visual acuity inclusion criteria as that of the larger Phase 3 FAME trial being conducted by Alimera (FAME subgroup), demonstrated that 55 percent of the high dose patients had an improvement in best corrected visual acuity (BCVA) of 10 letters or greater from baseline and 36 percent of the high dose patients had an improvement in BCVA of 15 letters or greater over baseline.
Among the low dose patients in the FAME subgroup, 23 percent had an improvement in BCVA of 10 letters or greater from baseline while no patients showed an improvement in BCVA of 15 letters or greater from baseline at this time point.
From a safety perspective, no patients receiving the low dose of Iluvien experienced intraocular pressure (IOP) increases of 30 millimeters of mercury (mmHg) or greater at any time point, while 29 percent of the patients receiving the high dose of Iluvien experienced IOP increases of 30mmHg or greater at some time point.
"Although any comparison of visual acuity response between the doses is confounded by the significant differences in baseline mean visual acuity, as well as the small sample size which is susceptible to single patient variability, the trends continue to be consistent with our expectations that sub microgram levels of corticosteroids will benefit this population," said Ken Green, Ph.D., chief scientific officer of Alimera Sciences. "The most significant safety signal, namely changes in IOP, continues to favor the low dose vs. the high dose."
Iluvien is an investigative, extended release intravitreal insert that Alimera is developing for the treatment of diabetic macular edema (DME). Each Iluvien insert is designed to provide a sustained therapeutic effect of up to 36 months, for the low dose of Iluvien, and up to 24 months, for the high dose of Iluvien. Iluvien is inserted into the patient's eye with a 25-gauge needle, which allows for a self-sealing wound. This insertion is very similar to an intravitreal injection, a procedure commonly employed by retinal specialists.
About Alimera Sciences, Inc.
Alimera Sciences is a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals. Presently the company is focused on diseases affecting the back of the eye, or retina. Its most advanced product candidate is Iluvien®, which is being developed for the treatment of diabetic macular edema, or DME.
DME is a disease of the retina, which affects individuals with diabetes and can lead to severe vision loss and blindness. Under one protocol, enrollment was completed in October 2007 in two Phase 3 pivotal trials for the use of Iluvien in the treatment of DME conducted across the U.S., Canada, Europe and India.
Alimera also has entered into an exclusive worldwide agreement with Emory University to explore oxidative stress management -- specifically the reduction of reactive oxygen species (ROS) -- as a treatment strategy for ophthalmic diseases. Under this agreement, Alimera has acquired options to exclusive, worldwide licenses for two classes of nicotinamide adenine dinucleotide phosphate reduced form (NADPH) oxidase inhibitors, which Alimera is studying as potential treatments for conditions such as the dry form of age-related macular degeneration (AMD), particularly the late stage of this condition known as geographic atrophy. Alimera has exercised its option to acquire a license with respect to one of these classes of NADPH oxidase inhibitors.
For more information on Alimera Sciences, visit www.alimerasciences.com.
Source: Alimera Sciences, Inc.
CONTACT: Katie Brazel of Fleishman-Hillard,
firstname.lastname@example.org, for Alimera Sciences
Web Site: http://www.alimerasciences.com/
Posted: September 2009