IOPtima Successfully Completes Initial Clinical Study For Glaucoma Using Novel Laser-Based Therapy
IOPtima, a subsidiary of Bio-Light Life Science Investments, announced that it has successfully completed the 3 month follow-up period for an initial human clinical study using the company\'s OT134 device and procedure. The novel, laser-based therapy enables eye surgeons to operate and reduce internal eye pressure without penetrating the eye membrane.
"The absence of any safety issues during the study and the impressive reduction in intra-ocular pressure suggest that our non-penetrating technology could revolutionize the way glaucoma is treated," said Dr. Joshua Degani, CEO of IOPtima.
"The study suggests that IOPtima\'s laser filtration system may offer significant efficacy and safety advantages, as well as reduces the potential risks, side effects and complications, over current surgical procedures. In addition our system may present an alternative to current drug therapies, many of which involve heavy medication regimens with poor patient compliance," said Dr. Ami Eyal, CEO of Bio-Light.
In the course of the study 13 patients were treated at a leading glaucoma center in Mexico City, under the supervision of Professor Felix Gil Carrasco, a prominent eye surgeon.
IOPtima intends to further monitor the patients for at least one year.
The study is the first leg in a multi-national clinical trial at leading ophthalmology centers around the world aimed at obtaining regulatory approval for Europe.
In addition, IOPtima plans to meet with the FDA in the near future in order to initiate procedures aimed at US regulatory approval.
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