IOPtima: Successful Results in Novel Glaucoma Treatment Using Laser-Based Therapy

RAMAT GAN, Israel-(Business Wire)-January 26, 2009 - IOPtima, the developer of an innovative laser based surgical device for reducing internal eye pressure for the treatment of glaucoma, successfully completed and analyzed the results of its first 6 month follow-up period of human clinical trials. IOPtima’s novel, laser-based technology enables eye surgeons to perform a simple and safe surgery and reduce internal eye pressure without penetrating the eye membrane. Elevated internal eye pressure, or intra-ocular pressure (“IOP”), is a key cause / risk factor of glaucoma, which in many cases causes the deterioration in the visual field and ultimately can lead to blindness without proper treatment to reduce and control IOP. The procedure, utilizing IOPtima technology, was performed with local anesthesia on an out-patient basis, and was demonstrated in these trials to be both safe and efficacious as a means to reduce IOP.

“The impressive reduction in intra-ocular pressure, the excellent safety profile demonstrated over a substantial period of time, and the ease of performing the operation, are all clear indications that our non-penetrating technology offers a major breakthrough in the way that glaucoma is treated,” said Dr. Joshua Degani, CEO of IOPtima.

Study results show compelling findings for all the main criteria:

Of the 30 patients who have completed the procedure and 6 months follow-up period, absolute internal eye pressure was reduced, on average, from 26.0 mmHg pre-operation to 14.0 mmHg post-operation.
The study "Complete Success" rate, defined as reducing internal eye pressure below 18 mmHg along with the complete elimination of any need for medications, was 86.7%.
The study "Qualified Success" rate, defined as reducing internal eye pressure below 18 mmHg, including cases where some post-operation medications were used, was of 93.5%.
The average number of medications per patient dropped from baseline of 2.28 to 0.27 at 6 months.
The post-operation adverse side effects reported were minor, as compared with contemporary glaucoma treatments.

“In addition to showing dramatic efficacy and safety advantages over current therapies, the study also demonstrated the simplicity of the procedure with which eye surgeons could be trained to use IOPtima’s laser filtration system. Our non–penetrating technology and procedure is very easy to perform, unlike other non-penetrating methods which, because of their difficulty, can only be implemented by a small number of highly-trained surgeons,” added Dr. Degani.

Noting the large market potential for the IOPtima system, Dr. Ami Eyal, Medical Director of IOPtima commented: “The patients in this study were all surgery-indicated but the IOPtima System may also be a welcome alternative for large numbers of patients currently using drug therapies, as patient compliance often is quite poor by most patients under drug therapies regimens, not to mention cost and side effects.”

IOPtima intends to further monitor the patients for at least one year post-operation. The study is a multi-national clinical trial aimed at obtaining regulatory approval for Europe. In addition, IOPtima has initiated discussions with the FDA aimed at US regulatory approval.

Prof. Mark Sherwood, a leading glaucoma surgeon, added: "Non-penetrating glaucoma surgery has generally demonstrated lower short-term complication rates than the gold-standard trabeculectomy surgery. However, it is a more challenging procedure to perform, requiring a high surgical skill-level and in some comparative trials has demonstrated less efficacy in achieving low-normal IOPs. The initial clinical study results using this new CO₂laser technique are exciting, with good post-operative mean IOP levels on few supplemental eye drops and a very low adverse event rate. The procedure is relatively easy to perform and the laser ablation is self-limiting, thus providing a more uniform surgical end-point. Further long term prospective studies are clearly warranted based on these initial results."

About IOPtima’s Technology

The most efficient currently-used surgical approach is known as Trabeculectomy. Non-Penetrating Deep Sclerectomy (“NPDS”) surgery is a similar but modified procedure causing a significantly smaller number of side effects. Both techniques 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 only penetrates to approximately 95% of the scleral depth while leaving a residual intact thin layer of several dozen microns. The benefit if this non-penetrating procedure is the significantly smaller rate of related adverse events as compared with Trabeculectomy. However, 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’s aim is to achieve the effect of NPDS while removing the risk of perforating the membrane 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 IOPtima System is expected to make NPDS surgery accessible to all eye surgeons in a safe, fast and cost effective manner.

The Market

It is estimated that nearly 67 million people worldwide suffer from glaucoma. Glaucoma is a chronic disease that requires life-long therapy. Medication treatments, amounting to $2-3 billion spent globally each year, often fail because of low patient compliance and because in many cases it has limited long term efficacy. Early surgical intervention is sometimes more effective than surgery performed after many years of drug therapy.

In the United States, glaucoma is the second leading cause of blindness. It is estimated that up to 3 million Americans, aged 40 and over, have glaucomaand 15 million more are at risk for vision loss from glaucoma. Today, about 500,000 surgical procedures are performed annually in the USA alone. The availability of a safe surgical procedure can be expected to significantly increase the number of surgical interventions.

About IOPtima

IOPtima Ltd. (formerly Optotech) focuses on the discovery, development and commercialization of innovative and proprietary technologies for the treatment of glaucoma – a common eye disease that leads to loss of sight. The company has developed an innovative non-penetrating, easy-to-use system, based on CO₂ laser technology, for the treatment of glaucoma. IOPtima believes that its innovative new system will offer significant advantages over traditional therapies for glaucoma, such as simplicity, higher efficacy, lower risks to the patient, fewer side effects and lower costs. The availability of a safe surgical procedure is expected to increase the number of surgical interventions. IOPtima holds a U.S. patent on the basic concept of the technology that it has developed for the treatment of glaucoma, and has filed requests for patent registration in additional countries and applications for additional patents.

IOPtima is a subsidiary of Bio-Light Life Science Investments, a management and holding company specializing in biomedical technologies. Bio-Light is traded on the Tel Aviv Stock Exchange under the symbol TASE:BOLT.

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