BioLight seeks FDA IND approval for subconjunctival Latanoprost controlled release insert Phase I/IIa study

Mar 31 2014

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.