ATLANTA, Oct. 1 Alimera Sciences, Inc., a privately heldbiopharmaceutical company that specializes in the research, development andcommercialization of prescription ophthalmic pharmaceuticals, today reportedthe interim month six safety and efficacy results from the first humanpharmacokinetic (PK) study of Iluvien(TM).
Iluvien is an intravitreal insert being developed for the treatment ofdiabetic macular edema (DME). DME is a disease of the retina, which affectsindividuals with diabetes and can lead to severe vision loss and blindness.Each Iluvien insert is designed to provide a sustained therapeutic effect, upto 36 months for the low dose and up to 24 months for the high dose. Iluvienis inserted into the patient's eye with a 25-gauge needle, which allows for aself-sealing wound. This insertion is very similar to an intravitrealinjection, a procedure commonly employed by retinal specialists.
This 36-month, open-label, Phase 2 PK study, running concurrently with thepivotal Phase 3 FAME(TM) Study of Iluvien (Fluocinolone Acetonide in DiabeticMacular Edema), is designed primarily to assess systemic exposure of thecorticosteroid, fluocinolone acetonide, after administration of Iluvien inpatients with DME. Secondarily, the PK study is designed to provideinformation 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 lowdose of Iluvien (an approximate 0.23 micrograms per day dose), and 17 patientson the high dose of Iluvien (an approximate 0.45 micrograms per day dose).
The six-month interim readout from the PK study showed 18 percent of thehigh dose patients had an improvement in best corrected visual acuity (BCVA)of 15 letters or greater over baseline. This is consistent with the three-month readout. The percentage of low dose patients that had an improvement inBCVA of 15 letters or greater from baseline decreased from 20 percent at thethree-month readout to 10 percent because one patient developed a cataract andone patient developed an epiretinal membrane involving the macula prior to thereadout. The development of cataracts and epiretinal membranes in a diabeticpopulation are not unusual and are commonly addressed with surgicalintervention.
In addition, the six-month readout showed 25 percent of the low dosepatients and 41 percent of the high dose patients had an improvement in BCVAof 10 letters or greater from baseline. This is an improvement from thethree-month data where 20 percent of low dose patients and 29 percent of highdose patients had gained more than 10 letters compared to baseline.
"It is very encouraging that the number of patients with greater than10-letter improvement has increased for both doses when comparing the six-month data to the three-month data," said Ken Green, Ph.D., chief scientificofficer of Alimera.
From a safety perspective, no adverse events related to intraocular, orinner eye, pressure were seen in the low dose patients, while 12 percent ofthe high dose patients experienced intraocular pressure increases of 30 mmHgor greater at some time point. Further, 10 percent of the low dose patientsand 12 percent of the high dose patients reported an adverse event related tocataract formation, and one additional patient in each dose group underwent acataract extraction.
"The six-month readout from the Iluvien PK study continues to support thepremise that corticosteroids, delivered in low doses in a consistent andsustained manner directly into posterior segment of the eye, can be anefficacious treatment for DME," said Dan Myers, president and CEO of AlimeraSciences, "We are also pleased with Iluvien's safety profile as evidenced bythe low IOP rates and the lack of filtration procedures at the month 6 timepoint."
Data from the PK Study will continue to be evaluated with interim looks atmonths 12, 18, 24, 30 and 36. Except for the month 12 and final month 36looks when the database will be fully locked, interim evaluations will bebased on unaudited data. The last patient was enrolled in this study at theend of February 2008.
About Alimera Sciences, Inc.
Alimera Sciences is a biopharmaceutical company that specializes in theresearch, development and commercialization of prescription ophthalmicpharmaceuticals. Presently the company is focused on diseases affecting theback of the eye, or retina. Its most advanced product candidate isIluvien(TM), which is being developed for the treatment of diabetic macularedema, or DME. DME is a disease of the retina, which affects individuals withdiabetes and can lead to severe vision loss and blindness. Under oneprotocol, enrollment was completed in October 2007 in two Phase 3 pivotaltrials for the use of Iluvien in the treatment of DME conducted across theU.S., Canada, Europe and India, with a combined total enrollment of 956patients.
Alimera also has entered into an exclusive worldwide agreement with EmoryUniversity to explore oxidative stress management -- specifically thereduction of reactive oxygen species (ROS) -- as a treatment strategy forophthalmic diseases. Under this agreement, Alimera has acquired options toexclusive, worldwide licenses for two classes of nicotinamide adeninedinucleotide phosphate reduced form (NADPH) oxidase inhibitors, which Alimerais studying as potential treatments for conditions such as the dry form ofage-related macular degeneration (AMD), particularly the late stage of thiscondition known as geographic atrophy. Alimera has exercised its option toacquire a license with respect to one of these classes of NADPH oxidaseinhibitors.
For more information on Alimera Sciences, visithttp://www.alimerasciences.com.
SOURCE Alimera Sciences, Inc.