BioLight Announces IND Filing with FDA for Phase I/IIa Clinical Study of its Controlled Release Latanoprost Insert for the Treatment of Glaucoma

TEL-AVIV, Israel, March 31, 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 ViSci, its wholly owned subsidiary, has filed an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) to conduct a Phase I/IIa clinical study with its subconjunctival Latanoprost controlled release insert for the treatment of glaucoma.

The 3-month study in 68 glaucoma patients is designed to prove the safety and efficacy of different doses of the insert containing its proprietary form of Latanoprost. Latanoprost is the most frequently prescribed glaucoma eye drop medication to lower Intra Ocular Pressure (IOP) in patients with glaucoma. Pending FDA approval, the study will be conducted at up to 7 investigative sites in the U.S.
Recently ViSci has successfully completed an ocular toxicology and safety study in animals. It holds an exclusive option from Novaer LLC to a worldwide exclusive license for any use of the insert's controlled release technology with any medication. Use of such insert is an effective solution to the well-known poor compliance with chronic eye-drop administration across the ophthalmic arena. Glaucoma, the first indication that the company has targeted, is estimated being a $4 billion USD worldwide market.
About BioLight
BioLight Life Sciences Investments invests in, manages and commercializes biomedical innovations grouped into "clusters" around defined medical conditions. The 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™, a laser-based noninvasive surgical treatment for glaucoma; TeaRx, a point-of-care dry-eye syndrome diagnostic test; and Eye-D™, a long-term controlled release drug-delivery implant platform. Micromedic diagnostic tests are designed to detect colorectal, cervical, breast, bladder, lung and other cancers. Base key investors, holding about 45% of BioLight's shares, are Mr. Israel Makov, Chairman of Sun Pharmaceuticals and Given Imaging, and former CEO and President of Teva Pharmaceuticals, with Mr. Dilip Shanghvi, founder 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 www.bio-light.co.il.
CONTACTS:
BioLight 
Itai Bar-Natan, CFO ([email protected]
Tel: 972-73-2753400
LHA 
Kim Sutton Golodetz ([email protected]
(212) 838-3777 
Or 
Bruce Voss ([email protected]
(310) 691-7100

SOURCE BioLight Israeli Life Sciences Investments Ltd.

Suggested Articles

The new digital Abilify is a breakthrough for Proteus Digital Health and its patient-tracking products, but not so much for Abilify's maker, Otsuka.

Adamis Pharmaceuticals' EpiPen contender Symjepi, which was rejected last year before the EpiPen havoc, won approval from the FDA.

Researchers in the U.K. have developed a technique to better predict results in liver cancer when drug-laden polymer beads are used to deliver medicines.