EyeTechCare SA, which is developing non-invasive therapeutic medical devices using ultrasound technology, announces 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 centers 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 (1.65), a large number of medications (3.2) and a high initial IOP (average = 29mm Hg, normal pressure is below 20).
- The new therapy confirms, as in the pilot study, an extremely favorable 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).
- Finally, the durability of the efficacy has now been documented with more than a year elapsed for the last patients in the pilot study, who still exhibit stable effects and excellent tolerability.
The pilot study started in March 2010 and involved 12 patients in three centers in France. Two were in Lyon and one in Paris. The results published in the IOVS journal in September 2011 were judged to be excellent by the ophthalmological community. They did, however, represent only a small number of patients (12) and the elapsed time was short (three months to a year), as a consequence the multicenter study EyeMUST was initiated.
Professor Philippe Denis
“This new treatment is of major interest for the treatment of glaucoma as it combines very good efficacy with excellent long term tolerability,” said Professor Philippe Denis, head of the ophthalmology service at the Croix-Rousse hospital in Lyon, France, and coordinating investigator for the study. “We now envision treating patients at an earlier stage of the illness. I was the first ophthalmologist to use the EyeOP1(R) device and the UC3 procedure on humans, and I find the system very simple to use, with a very short learning curve. I also like the fact that it is very quick – it takes no more than two minutes to carry out the treatment.”
EyeTechCare has recently begun an extensive international study, EyeMUST2, which will ultimately involve 12 centers 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 centers 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.”
Professor Shlomo Melamed
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.”
“Given the growing demand from patients and investigators in France and internationally, we hope we can soon apply UC3 treatment to patients who have never undergone surgery before,” said the chairman of EyeTechCare, Fabrice Romano. “We plan to put our device on the market when we release the final results of our EyeMUST study in the fourth quarter 2012 so as to respond to the considerable hopes that have been raised for the improvement of the overall treatment of patients suffering from glaucoma. We have the only totally non-invasive technique which seems to achieve efficacy comparable to surgery while substantially reducing the risks and drawbacks usually associated with it.”