OcumatRx, an early stage company that is developing a medical device that represents a new concept for the permanent treatment of patients with glaucoma, has announced the successful completion of clinical trials for their first device with favourable preliminary safety and tolerability. As a result, the company is now moving forward with a more sophisticated design of the device, with plans to launch new clinical trials later this year.
Dr Bernard Press, president of OcumatRx, said that after years of research and development, the CaPRI device, named after its inventor, Dr David Castillejos, an ophthalmologist, who pioneered the pressure reduction implant (PRI) technology, showed significant results in lowering intraocular pressures during recent trials conducted in Mexico. During the trials involving 10 patients aged from 40 to 75, the first generation of the CaPRI device was inserted into one eye and the other eye was used as the control.
Press said the subjects were tested over a 12 month period and at the end of the trial the average drop in pressure was 6.4 millimeters, an achievement, he claims, which is better than the current standard of care for increased intraocular pressure, which is using prescription drops.
"We are encouraged by the early results and are now finalising the next generation of the device, designed by Dr Castillejos after further research and development," said Press. "For glaucoma patients, having a permanent implant has the potential to stabilize pressure without the need for expensive drops, which can lose efficacy over time."
The CaPRI is inserted in a minimally invasive procedure, stabilizes intra-ocular pressure and stops the progression of Glaucoma in the early stages, before it begins advancing toward tunnel vision and eventual blindness, according to Dr Castillejos, chief medical officer of OcumatRx. By taking advantage of the unique shape of the device, it creates multiple draining sites, thus decreasing the chance of scar tissue, blocking the effect of the device and improving stability of the implant.
Castillejos is working with custom device manufacturers on the technologically advanced new design.
"The second generation device can be implanted more easily, adds more surface area and we believe it will increase both effectiveness and patient comfort," said Dr Castillejos. "As soon as we complete evaluation of a new prototype, we will be scheduling a series of pre-clinical and clinical trials as soon as possible.
Given the results of the clinical trials this year in foreign countries, OcumatRx will be filing to market the new device in Europe and Asia in early 2010 while it pursues the clinical and regulatory steps necessary to market in the US and other countries, Press said.