MIAMI, Oct. 10 /PRNewswire-FirstCall/ -- OPKO Health Inc. today announced that it has acquired exclusive worldwide rights for ophthalmic uses to a topical clinical stage compound with potential utility in the treatment of dry eye.
“Dry eye is an increasingly common condition that can disrupt the lives of those afflicted. It can cause significant discomfort and interfere with vision and everyday activities,” said Sam Reich, Executive Vice President of Ophthalmologics at OPKO. “There is only one FDA approved prescription product currently available for dry eye, and we look forward to moving quickly to develop this product as a new and potentially better treatment option.”
The compound, civamide, a proprietary TRPV-1 receptor modulator and neuronal calcium channel blocker, is in Phase III clinical trials in an intranasal formulation to treat various types of pain. Increased tear production was observed in over 50% of the patients receiving civamide, and no systemic side effects were noted. Preliminary evidence suggests that civamide’s effects on tear production result from its ability to modify signal transduction pathways present in the human lacrimal gland.
“Acquiring rights to this late stage drug candidate reflects our strategy of proactively seeking new products and businesses to help fuel growth at OPKO,” said Phillip Frost, M.D., Chairman and CEO of OPKO Health. “This late stage, topically administered compound with demonstrated safety has the potential to reach the market relatively quickly. It addresses a significant unmet need which creates a sizeable opportunity.”
Terms of the agreement were not disclosed.
About Dry Eye
Dry eye syndrome is caused by a variety of conditions such as insufficient tear production. It is estimated that 30 to 40 million Americans suffer from the symptoms of dry eyes. Dry eye syndrome is more common with advancing age and the incidence appears to be increasing. Our aging population and the increasing popularity of procedures that can cause dry eye, such as vision- correction surgery and cosmetic eyelid surgery, may be contributing to the increased incidence. Symptoms of dry eye include itching and pain, light sensitivity and stinging. Dry eye patients can experience vision impairment and can have trouble keeping their eyes open for prolonged periods. Current treatments include over-the-counter and prescription eye drops, which can cause irritation, often work only after many weeks of administration and are often ineffective.
About OPKO Health, Inc.
Miami-based OPKO is a specialty healthcare company. Its lead investigational drug, the pioneering gene silencing agent bevasiranib, has entered a pivotal Phase III trial after successfully completing Phase II trials for wet age-related macular degeneration and diabetic macular edema. OPKO is developing a preclinical pipeline of novel agents for ophthalmic diseases and presently markets diagnostic systems that complement its therapeutic products.
This press release contains “forward-looking statements,” as that term is defined under the Private Securities Litigation Reform Act of 1995 (PSLRA), regarding product development efforts and other non-historical facts about our expectations, beliefs or intentions regarding our business, technologies and products, financial condition, strategies or prospects. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements. These factors include those described in our filings with the Securities and Exchange Commission, as well as risks inherent in funding, developing and obtaining regulatory approvals of new, commercially-viable and competitive products and treatments, including the risks that that any of our compounds under development, including civamide, may fail, may not achieve the expected results or effectiveness and may not generate data that would support the approval or marketing of products for the indications being studied or for other indications, that civamide may not reach the market quickly, or at all, or have effectiveness comparable to or better than currently used treatments for dry eye. In addition, forward-looking statements may also be adversely affected by general market factors, competitive product development, product availability, federal and state regulations and legislation, the regulatory process for new products and indications, manufacturing issues that may arise, patent positions and litigation, among other factors. We do not undertake any obligation to update forward-looking statements. We intend that all forward- looking statements be subject to the safe-harbor provisions of the PSLRA.
CONTACT: Corporate, Steven D. Rubin, +1-305 575-6015, or Media, Barbara
Lindheim, +1-212 918-4650
