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news.IOPtima, a subsidiary of Bio-Light Life Science Investments, has successfully completed the three month follow-up period for an initial human clinical study using the company's OT134 device and procedure.
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In the course of the study 13 patients were treated at a glaucoma center in Mexico City, under the supervision of Felix Gil Carrasco, an 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.
According to the company, the novel, laser-based therapy enables eye surgeons to operate and reduce internal eye pressure without penetrating the eye membrane. The OT134 is expected to make non-penetrating deep sclerectomy surgery accessible to all eye surgeons in a safe, fast and cost effective manner.
Ami Eyal, CEO of Bio-Light, said: “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.”