OT134, a laser therapy for the reduction of intraocular pressure, has completed the follow-up period of its first human clinical study.
OT134, a laser therapy for the reduction of intraocular pressure (IOP), has completed the follow-up period of its first human clinical study.
The trial of OT134, a CO2 laser produced by IOPtima, treated 13 patients in Mexico City. This is the first leg of a multicentre, multinational clinical trial. At three months, results have been impressive, with significant decreases in IOP and no reports of adverse events. Patients will be followed up for one year.
As OT134 does not require penetration of the eye membrane, IOPtima hopes that it will come to replace both sclerectomy and non-penetrating deep sclerectomy, which, despite being non-penetrating, nevertheless carries the risk of perforation.
Pending further clinical trials, IOPtima plans to submit the OT134 device and process for FDA and European approval.