EyeTechCare SA, a company developing non-invasive therapeutic medical devices using ultrasound technology for ophthalmology market,  has announced the preliminary results of EyeMUST, a multicenter study of the use of its EyeOP1 device in glaucoma.
 
The study, launched in September 2011 was carried out on 60 patients in nine centres in France (Lille, Paris, Dijon, Lyon and Grenoble). The aim was to confirm the positive results of the pilot study on a larger population and with patients having a less advanced form of glaucoma.
 
Preliminary study results were presented on June 19, 2012 at the European Glaucoma Society congress in Copenhagen. They confirm all the conclusions of the pilot study. The main points were: Treatment with UC3 (Ultrasonic Circular Cyclo-Coagulation) showed that between 82–90 per cent of patients responded favorably, depending on the group, with an average reduction in intra-ocular pressure (IOP) of 42– 49 per cent;.The method shows efficacy even with patients presenting advanced glaucoma and having undergone several unsuccessful surgical interventions, a large number of medications and a high initial IOP (average = 29mm Hg, normal pressure is below 20).; The new therapy confirms, as in the pilot study, an extremely favourable risk profile as no major side effects have been observed almost two years after the start of treatments and with more than 70 patients treated; Similarly, the remarkable tolerability of the treatment was confirmed. Eyes present very few signs of inflammation. There were no post-operative IOP spikes or pain in the vast majority of patients (more than 95 per cent).
EyeTechCare has recently begun an extensive international study, EyeMUST2, which will ultimately involve 12 centres in six countries (Italy, Israel, Switzerland, United Kingdom, Germany and Spain). It will cover 120 patients. The aim is to gather clinical data from different centres of excellence, on patients more representative of the standard glaucoma population and with a longer elapsed time. The first results should be available in early 2013.
 
Prof. Shlomo Melamed, professor of ophthalmology, director of the Sam Rothberg Glaucoma Center, Israel has recently performed eight HIFU interventions as part of the EyeMUST2 post-market study. Asked if new technologies like HIFU are really needed, he said: "Absolutely, yes. We certainly need to improve. HIFU may offer a gentler alternative to current cycloablative procedures, which are associated with severe complications, relatively low success rate and excessive need for retreatments. If studies are positive, we should consider application in earlier and less severe cases.”
 
In a presentation at the Copenhagen conference, and referring to the eight patients he had treated using the EyeOP1 device, he observed: “All the patients came back smiling the next day. That’s very rare in glaucoma patients.”