RAMAT GAN, Israel — IOPtima, a Bio-Light Life Sciences subsidiary, has received CE approval for its OT-134 laser-based therapy for treating glaucoma, the company announced in a press release.
The novel CO2-based system, known as IOPtiMate, allows for noninvasive filtration to reduce IOP, the release said.
The approval will allow IOPtima to market the IOPtiMate in all European countries and other countries that recognize the CE mark. Accordingly, IOPtima has begun preparations to distribute the IOPtiMate in Europe, where the company plans to cooperate with a strategic partner to utilize a pay-per-procedure model for the platform. A pay-per-procedure model with a strategic partner in India is under way.
IOPtima expects to receive U.S. Food and Drug Administration approval of the IOPtiMate next year.
"The company has an agreement with a U.S.-based producer for an initial supply of the IOPtiMate and is preparing for the distribution phase of the product," Dr. Joshua Degani, CEO of IOPtima, said in the release.