Roanoke, VA (1888PressRelease)
July 14, 2009 - OcuCure Therapeutics, Inc., a biopharmaceutical company specializing in the treatment of eye disease, reported final results from primate testing of its lead compound OC-10X, currently under development as a topical eye drop treatment of age-related macular degeneration (AMD). Results indicated a 43 percent inhibition of ocular neovascularization in primate eyes treated with OC-10X. The laser-induced choroidal neovascularization (CNV) primate model is considered the gold standard to demonstrate AMD efficacy.
These compelling results follow earlier successful safety and efficacy studies in rabbits and rats. OC-10X demonstrated both antiangiogenic (inhibition) and angiolytic (regression) properties in animal models of AMD when administered as a topical eye drop. OC-10X is also being evaluated for the treatment of diabetic retinopathy (DR).
“This primate efficacy data is very impressive and suggests that OC-10X may have an important role in the management of exudative AMD in humans,” commented Craig M. Greven, MD, Professor and Chairman of the Department of Ophthalmology at Wake Forest University, consulting Chief Medical Officer for OcuCure.
The primate studies were conducted at the Eastern Virginia Medical School T.R. Lee Center for Ocular Pharmacology. CNV was induced (using laser photocoagulation) in both eyes of eight primates followed by intravitreal injection of OC-10X in one eye; the other eye served as the control. Two weeks later, a second injection was administered. Four weeks after the initial laser injury, the areas of CNV lesions were measured. The 43 percent difference between the smaller CNV lesion in the OC-10X treated eyes when compared to the larger lesions in the untreated control eyes was statistically significant (t-test, p=0.025).
“This primate experiment corroborates our previous animal efficacy studies,” stated Patricia B. Williams, PhD, OcuCure’s Chief Scientific Officer. “Most other AMD therapies work at the cell signaling level by inhibiting growth factor effects. In contrast, OC-10X works independently of growth factors and thus could provide better long term visual outcome and overall efficacy,” she added.
This successful primate study follows long-term OC-10X safety studies recently presented at the annual meeting of the Association for Research in Vision and Ophthalmology, held in Fort Lauderdale, Fla. After long-term topical administration of six to nine months, no changes in corneal or retinal histology or function were observed. Electroretinogram (ERG) studies showed that retinal function remained normal during this long- term testing. Additionally, complete blood counts, clinical blood chemistry panels, and gross necropsy indicated no evidence of major organ dysfunction.
“We’re encouraged by these findings, because the primate model is a reasonable predictor of human clinical data,” said OcuCure’s President and CEO Sunder Malkani. “Given the robustness of the efficacy and safety data, coupled with the unique properties of OC-10X, OcuCure is an attractive opportunity, with the potential to change the AMD therapeutic landscape.”
About OcuCure
OcuCure Therapeutics is a biopharmaceutical company, formed in August 2005 based on initial drug discovery research supported by the Carilion Biomedical Institute. The Company’s lead compound, OC-10X, targets Age-related Macular Degeneration (AMD), the leading cause of blindness in developed countries, and diabetic retinopathy (DR), the leading cause of blindness in the U.S. among adults age 24-70. OcuCure’s management team and Board of Directors are comprised of individuals experienced in creating and growing eye care businesses. Its intellectual property is protected by several U.S. and foreign patent applications. OcuCure has met with the FDA to review current progress, the requirements for clinical trials, and the regulatory pathway. More information on OcuCure is available on the Company's web site at http://www.ocucure.com.
About Age Related Macular Degeneration (AMD)
AMD is a debilitating eye disease and is the leading cause of legal blindness in developed countries. Nearly one in three people over the age of 65 develop AMD. As the number of elderly people increases, so will the prevalence of AMD. There are two forms of AMD, dry and wet. About 10 to 15 percent of AMD patients develop the wet form. In wet AMD, the growth of new abnormal fragile blood vessels under the retina can lead to rapid vision loss and blindness.
About Diabetic Retinopathy (DR)
Like AMD, diabetic retinopathy is a major cause of blindness in American adults and also is caused by the growth of abnormal blood vessels. These new blood vessels are fragile and may leak fluid and blood into the retina. DR affects up to 80 percent of all diabetics who have had diabetes for 15 years or more. There are no drugs approved for the treatment of DR.
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