IOPtima, a subsidiary of Bio-Light, the developer of a laser-based surgical device for reducing intra ocular pressure for the treatment of glaucoma, has 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 internal eye pressure (IOP) without penetrating the eye membrane. The procedure, utilizing IOPtima technology, after 12 months follow-up, demonstrated to be both safe and efficacious as a means to reduce IOP.
According to IOPtima, the combined results of the study in Mexico and India demonstrated an average reduction of 43% in IOP from 25.5mmHg pre procedure to 14.6mmHg 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, (IOP of less than 18mmHg, regardless of medication) of 95% of those treated in the study, and complete success, (IOP of less then 18mmHg with no additional medications), of 67%. These 12-month follow-up results are considered reflective of long-term success in IOP reduction, and indicative maintaining of lower IOP for extended periods, the company said.
Joshua Degani, CEO of IOPtima, said: 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.