IOPtima's novel laser therapy aces initial clinical study for glaucoma
June 12, 2008 -- IOPtima (Ramat Gan, Israel) says it has successfully completed the three-month follow-up for the initial human clinical study using its OT134 device and procedure. The laser-based therapy enables eye surgeons to operate and reduce intra-ocular pressure without penetrating the eye membrane. "Our non-penetrating technology could revolutionize the way glaucoma is treated," said IOPtima's CEO.
June 12, 2008 -- IOPtima (Ramat Gan, Israel), a subsidiary of Bio-Light Life Science Investments (TASE:BOLT), says it has successfully completed the three-month follow-up period for an initial human clinical study using the company's OT134 device and procedure. The 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.
And according to parent company Bio-Light's CEO Dr. Ami Eyal, 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." Eyal also noted that the system shows promise as an alternative to current drug therapies, "many of which involve heavy medication regimens with poor patient compliance," he said.
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.
IOPtima's aim is to achieve the effect of non-penetrating deep sclerectomy (NPDS) surgery while removing the risk of perforating the membrane and minimizing the risk of perforating the scleral tissue via its CO2 laser-based system which is self-terminating once the desired scleral thickness has been achieved. This elegant self-regulation is possible because the CO2 laser essentially stops ablating as soon as it comes in contact with the intra-ocular percolated liquid, which is what occurs as soon as the laser reaches the optimal residual intact layer thickness.
The company hopes its OT134 will make non-penetrating deep sclerectomy surgery accessible to all eye surgeons in a safe, fast and cost effective manner.
Currently the most efficient currently-used surgical approach is trabeculectomy; NPDS is a similar but modified procedure causing a significantly smaller number of side effects. Both approaches reduce intraocular pressure, the key cause of glaucoma, by removing scleral tissue in a small flap of the eye. Whereas in conventional trabeculectomy, the surgeon penetrates through the wall of the eye, in the NPDS procedure, the surgeon penetrates only to approximately 95% of the scleral depth while leaving a residual intact thin layer of several dozen microns. Doing so without inadvertently perforating the thin trabecular membrane is at present very demanding, very time consuming and requires great skill and vast experience. Consequently only a small number of eye surgeons are able to perform this procedure, and the potential benefits of the non-penetrating surgical approach are not widely available to glaucoma patients.