IOPtima: Successful Long-Term Results In The Use Of Its Novel Laser System For The Treatment Of Glaucoma

Main Category: Eye Health / Blindness
Also Included In: Medical Devices / Diagnostics
Article Date: 29 Apr 2009 - 0:00 PDT

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IOPtima, a subsidiary of Bio-Light (TASE:BOLT), the developer of an innovative laser-based surgical device for reducing intra ocular pressure (IOP) for the treatment of glaucoma, successfully completed and analyzed the results of its first 12-month follow-up period of human clinical trials conducted in Mexico and India.

IOPtima's novel, laser-based technology enables eye surgeons to perform a simple and safe surgery and reduce IOP without penetrating the eye membrane. Elevated internal eye 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. The procedure, utilizing IOPtima technology, after 12 months follow-up, demonstrated to be both safe and efficacious as a means to reduce IOP.

"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 Dr. Joshua Degani, CEO of IOPtima.

Study results show compelling findings for all the main criteria:

- The combined results of the study in Mexico and India demonstrated an average reduction of 43% in IOP from 25.5 mmHg' pre procedure to 14.6 mmHg' after 12 months follow-up.

- In addition, the Company's procedure reduced the number of medications taken by the treated patients from 2.6 medications to 0.6, on average.

- These results reflect a Qualified success, (i.e. IOP of less than 18 mmHg', regardless of medication) of 95% of those treated in the study, and Complete success, (i.e. IOP of less then 18 mmHg' with no additional medications), of 67%.

12-month follow-up results are considered reflective of long-term success in IOP reduction, and indicative maintaining of lower IOP for extended periods.

About IOPtima's Technology

IOPtima's technology utilizing a CO2 laser-based system to ablate the scleral membrane to a thinness which will enable the percolation of the intra ocular fluid, without penetrating the inner eye. The use of the CO2 laser 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 such non-penetrating 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 glaucoma and 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.

Source
IOPtima

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