MAY 13, 2009--IOPtima (Ramat Gan, Israel) says its laser-based therapy for reducing intraocular pressure (IOP) without penetrating the eye membrane has proven safe and effective. The statement references a 12-month followup to human clinical trials in Mexico and India investigating glaucomatreatment. The company's OT134 carbon dioxide laser to ablate the scleral membrane to an optimal thickness that allows percolation of intraocular fluid.
"The long-term maintenance of the IOP reduction, compiled with the high safety profile, as demonstrated in our clinical studies, place IOPtima's system for glaucoma treatment in the first line of accepted glaucoma treatments," said IOPtima CEO Dr. Joshua Degani.
Combined results showed an average reduction in IOP from 25.5 mm Hg to 14.6 mm Hg (43%). Data also showed that the procedure reduced the average number of glaucoma medications from 2.6 to 0.6. The procedure kept IOP below 18 mm Hg regardless of medication use in 95% of patients and under 18 mm Hg with no additional medications in 67% of patients.
IOPtima's goal 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.
IOPtima is a subsidiary of Bio-Light Life Sciences. For more information see the IOPtima page on the Bio-Light website.