IOptima wins CE approval for laser glaucoma treatment; aims for FDA clearance in 2010
AUGUST 10, 2009--IOPtima (Ramat Gan, Israel) says it has received CE approval for its laser based system for noninvasive treatment of glaucoma. IOPtima designed its novel CO2 laser system, IOPtiMate OT-134, to enable a fast, simplified, efficient and cost-effective filtration procedure to alleviate intra-ocular pressure, which is the primary cause of damage to the optic nerve in glaucoma patients. The approach, says IOPtima, is expected to compete as the preferred first line of glaucoma treatment.
"…we are gearing ourselves towards commercializing the product," said CEO Dr. Joshua Degani. "The company has an agreement with a US based producer for an initial supply of the IOPtiMate and is preparing for the distribution phase of the product." IOPtima is simultaneously working toward approval of the IOPtiMate by the US Food and Drug Administration (FDA), and hopes to win the approval next year.
IOPtiMate is the company's first product, though IOPtima is in advanced stages of completion of the OT-135, the next generation of the IOPtiMate. Degani says that the CE regulatory approval was achieved in a relatively short period due to the compelling safety and efficacy data achieved in multi center clinical trials conducted across three continents. The outcome of the CE regulatory approval is that the IOPtiMate can now be clinically and commercially implemented in all European and other jurisdictions which accept the CE as a binding regulatory guideline.
IOptima is currently setting the foundations for distributing and implementation of the IOPtiMate in Europe, where the company intends to implement a pay-per-procedure model through cooperation with a strategic partner. The company has already begun implementation of this model in India, in conjunction with a strategic partner.
Approximately 57.5 million people worldwide suffer from glaucoma, which is a chronic disease requiring constant treatment. The cost of medication treatment of glaucoma, the currently most common form of treatment, is estimated to be above $3 billion every year. Such medications, though initially effective, are challenged by very poor patient compliance and, at times, limited long term efficacy.
In the US, glaucoma is said to be the second most common cause for blindness and more than 3 million people over the age of 40 are afflicted.
IOptima is a subsidiary of Bio-Light, Israeli Life Sciences Investments Ltd., a management and holding company specializing in developing Life Sciences developments. Bio-Light is traded on the Israeli Stock Exchange under the symbol TASE:BOLT.
For more information, please see the IOPtima page on Bio-Light's website.
Posted by Barbara G. Goode, [email protected], for BioOptics World.