Bio-Light Israeli Life Sciences Investments Ltd. (TASE:BOLT) portfolio company IOptima Ltd. yesterday reported the 12-month monitoring results of clinical trials for its OT134 device and procedure for glaucoma. The company said that the intermediate results were encourageing.
The safety and effectiveness trials are being conducted in Mexico and India. The OT134 is a laser-based non-invasive surgical procedure of the eyeball to treat glaucoma.
In the Mexico study, IOptima reports a 37% average reduction in internal eye pressure from 23 millimeters of mercury (mm Hg) to 14.3 mm Hg. Success in the trial is defined as an average reduction in pressure of at least 20% and to below 21 mm Hg. No side effects have been reported among the patients one year after the procedure.
Use of OT134 also reduced the quantity of medication used by the patients from an average of three drugs per patient to 0.8.
The intermediate results represent a "qualified success" rate of 95%, with qualified success defined as eye pressure less than 18 mm Hg with or without medication, and a "complete success" rate of 45%, defined as eye pressure less than 18 mm Hg without any medication.
In the Indian study, the average reduction in internal eye pressure fell 51% from 29.3 mm Hg to 14.9 mm Hg. The results represent a 100% qualified and complete success.
IOptima is now waiting for the 12-month monitoring results from a trial in Russia, as well as the results from recently begun trials at leading medical centers in Western Europe.
Published by Globes [online], Israel business news - www.globes-online.com - on April 21, 2009
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