OcuCure Therapeutics? Topical Vascular Targeting Agent Demonstrates Long Term Safety

Ophthalmic Drug’s Unique Properties to Benefit Patients with AMD, Diabetic Retinopathy

Roanoke, Va. (June 17, 2009)--OcuCure Therapeutics, Inc., an early stage biopharmaceutical company specializing in the treatment of eye disease, reported final results from its recently completed long-term (nine month) animal safety testing of OC-10X. OC-10X, OcuCure’s lead compound, is under development for the treatment of age-related macular degeneration (AMD). When administered as a topical eye drop, OC-10X has demonstrated both antiangiogenic (inhibition) and angiolytic (regression) properties in animal models of AMD. OC-10X is also being evaluated for the treatment of diabetic retinopathy (DR).

To demonstrate long term safety, the topical eye drop was administered three times a day to rats for nine months (1% OC-10X, t.i.d.). Studies were conducted at Eastern Virginia Medical School’s T.R. Lee Center for Ocular Pharmacology . “Most importantly, no significant changes in corneal or retinal histology or function were observed after long-term administration,” said Patricia B. Williams, PhD, OcuCure’s Chief Scientific Officer. “Complete blood counts, clinical blood chemistry panels, and gross necropsy showed no evidence of major organ dysfunction even after six to nine months. Additionally, electroretinogram (ERG) studies showed that retinal function remained normal during this long- term testing.” Findings were presented at the May 2009 meeting of the Association for Research in Vision and Ophthalmology, held in Fort Lauderdale, Florida.

“Absence of ocular and systemic toxicity is extremely important to the treatment of patients with AMD or DR due to the chronic nature of these diseases,” said OcuCure President and CEO Sunder Malkani. “These data represent an important milestone toward the demonstration of the safety of long-term OC-10X treatment.”

Unlike other therapies for AMD, OC-10X provides the efficacy of a vascular targeting agent without the traditional toxicity associated with such drugs. It is this uniqueness which makes OC-10X attractive for long-term therapy. OC-10X has demonstrated pre-clinical efficacy to regress choroidal neovascularization (a characteristic of the “wet” form of AMD) as well as to inhibit the growth of new blood vessels. Most other therapies work upstream at the cell signaling level by inhibiting growth factor effects.  OC-10X, as a tubulin inhibitor, works downstream independently of growth factors.  Thus, OC-10X could provide better long term visual outcome and overall efficacy.

Craig M. Greven, MD, Professor and Chairman of the Department of Ophthalmology at Wake Forest University is the consulting Chief Medical Officer for OcuCure. Dr. Greven commented, “Earlier studies on rats and rabbits with the OC-10X topical eye drop demonstrated penetration to the back of the retina at clinically significant concentrations. Administration of OC-10X as topical therapy, along with the novel mechanism, has the potential to provide benefits to patients with ocular diseases associated with angiogensis.”

OcuCure was formed in August 2005 based on initial drug discovery research supported by the Carilion Biomedical Institute. OcuCure’s skilled 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 conducted meetings with the FDA to review current progress, the requirements for clinical trials, and the regulatory pathway.

  About Age Related Macular Degeneration (AMD)

AMD is a debilitating eye disease and is the leading cause of legal blindness in developed countries. Almost 1 in 3 people over the age of 65 develop AMD. As the number elderly people increases, so will the prevalence of AMD. There are two forms of AMD, dry and wet. About 10 to 15 % 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 is also 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% of all diabetics who have had diabetes for 15 years or more. There are no drugs approved for the treatment of DR.

About OcuCure

 

OcuCure Therapeutics is an early stage biopharmaceutical company developing new proprietary drugs and technologies to reduce and prevent vision loss caused by eye diseases. 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. More information on OcuCure is available on the Company's web site at http://www.ocucure.com.

Contact: John Carlin, 540.204.4027, jcarlin@visitaccess.com

Posted: June 2009

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