First Patient Enrolled In FDA Phase 1/2a Clinical Trial With Biolight's Controlled-Release Latanoprost Insert For The Treatment Of Glaucoma
6/30/2014 9:02:09 AM
TEL AVIV, Israel, June 30, 2014 /PRNewswire/ --
BioLight Israeli Life Sciences Investments Ltd. (TASE: BOLT)(OTCQX: BLGTY), a firm that invests in, manages and commercializes biomedical innovations grouped into clusters around defined medical conditions, announces that the first patient has been enrolled in the U.S. into a FDA Phase 1/2a clinical trial with Eye-D(R) , the company's controlled-release latanoprost insert for the treatment of glaucoma.
This randomized, dose-finding trial to evaluate the safety and ocular hypotensive efficacy of Eye-D(R) latanoprost controlled-release insert will enroll up to 68 glaucoma patients at seven investigative sites across the U.S. Patients will be studied for three months and will receive one of three doses of controlled-release latanoprost or once-daily dosed latanoprost eye drops. The study is expected to be completed in the first quarter of 2015.
Latanoprost is the most frequently prescribed eye drop medication to lower Intra Ocular Pressure (IOP) in patients with glaucoma or ocular hypertension. ViSci, Ltd., BioLight's wholly owned subsidiary, is the trial's sponsor.
"We are extremely pleased that our US clinical sites have begun recruiting patients for this trial," said Suzana Nahum-Zilberberg, BioLight's chief executive officer, "This trial is designed to provide us in a relatively short time frame clinical information regarding safety and efficacy that will support our future development program for glaucoma and other indications."
Keren Leshem, ViSci's CEO, said: "Enrollment of the first patient into this clinical study represents another significant milestone in the development of our novel Eye-D(R) controlled-release insert. We believe this insert will provide an effective solution to the well-known poor compliance associated with the chronic administration of eye drops commonly used today to treat glaucoma."
Richard L. Lewis, M.D., President of the American Society of Cataract and Refractive Surgeons (ASCRS) and a glaucoma specialist in Sacramento, Calif. who assisted the study design and procedure, said: "This is a very important step in a new direction for treating glaucoma using a medication. The Eye-D(R) has the potential to introduce an easy-to-administer, safe and highly effective solution that will assist patients worldwide, while being well accepted among clinicians."
BioLight, through its wholly owned subsidiary ViSci, holds an exclusive global option for exclusive license from Novaer LLC for use of the insert's proprietary technology. Recently Novear was granted a patent by the U.S. Patent and Trademark Office covering the proprietary formulation of latanoprost. The patent is intended to protect, inter alia, the chemical structure of the active ingredient for the treatment of glaucoma. The patent also covers the release of the active ingredient from the Eye-D(R) subconjunctival insert and its use in treating elevated IOP in patients with glaucoma or ocular hypertension. The patent and its registration will be in effect until at least April 2030.
Glaucoma, which is associated with increased pressure within the eye, causes damage to the optic nerve that may lead to full or partial blindness, and is considered the second most common cause of blindness worldwide. According to estimates commonly accepted in the field, there are now about 67 million people worldwide that suffer from the disease. Glaucoma is usually a chronic disease that requires lifelong treatment, and the global market for drug therapy and surgery is estimated at $4 billion annually.
BioLight Life Sciences Investments invests in, manages and commercializes biomedical innovations grouped into "clusters" around defined medical conditions. Its two current clusters are in ophthalmology via 100% ownership of XLVision Sciences and in cancer diagnostics via a 29% controlling ownership of Micromedic (TASE: MCTC). XLVision technologies include IOPtiMate(TM), a laser-based noninvasive surgical treatment for glaucoma; TeaRx, a point-of-care dry-eye syndrome diagnostic test; and Eye-D(R) , a long-term controlled release insert platform. Micromedic diagnostic tests are designed to detect colorectal, cervical, breast, bladder, lung and other cancers.
BioLight leading key investors, holding about 45% of BioLight's shares, are Mr. Israel Makov, Chairman of Sun Pharmaceuticals, former CEO and President of Teva Pharmaceuticals and former Chairman of Given Imaging, Mr. Dilip Shanghvi, founder and managing director of Sun Pharmaceuticals, India's largest pharmaceutical company, and Mr. Dan Oren, founder and CEO of Dexcel Pharma, the second-largest pharmaceutical manufacturer in Israel.
For more information please visit the Company's website at http://www.bio-light.co.il.
Itai Bar-Natan, CFO
Kim Sutton Golodetz
SOURCE BioLight Israeli Life Sciences Investments Ltd.
Help employers find you! Check out all the jobs and post your resume.
comments powered by