Tuesday, October 20, 2015

Oraya IRay Update 4: Oraya Therapeutics Receives Guidance for Use in Germany

When I last updated the progress of Oraya Therapeutics, in January of this year (Oraya IRay Update 3: Oraya Now Operating at Nine European Centers and Partnership with Carl Zeiss Meditec), I noted the collaboration agreement between Oraya and Carl Zeiss Meditec to provide funding to Oraya over a period of up to two years for the implementation of Oraya's growth strategy, and I reported on the three-year INTREPID safety results, presented the previous September. Here now is the latest information on the progress of the company to bring this adjunctive treatment for the wet form of AMD to the professions.

The German Ophthalmological Society, the Retina Society and the Professional Association of German Ophthalmologists (DOG) have issued a joint opinion on the adjunctive use of radiotherapy with Oraya Therapeutics' IRay Stereotactic Radiotherapy System for wet AMD. Their opinion makes it possible for ophthalmologists throughout Germany to identify patients that can benefit from Oraya Therapy in conjunction with anti-VEGF treatment.

Oraya Therapy is currently commercially available at eleven sites in Europe, with more than 550 patients treated to date with Oraya Therapy in three European countries - Germany, Switzerland and the United Kingdom.

According to the opinion, which takes the study data published to date into account, adjunctive stereotactic radiotherapy of neovascular AMD with the IRay system can be considered on an individual basis. Some of the parameters that ophthalmologists should consider include:

●    If symptoms of choroidal neovascularization (CNV) activity such as intra-retinal fluid of bleeding are present, corresponding to a recommendation of VEGF inhibitors;
●    If the ongoing anti-VEGF therapy has taken place over a period of at least six months, thus ruling out undertreatment; and,
●    If despite intensive injection therapy, no change in the activity state of the CNV is achieved and there is no reasonable expectation of a decrease of the required high frequency of retreatment for the future.

"The joint opinion now provides guidance for ophthalmologists throughout Germany to identify those patients who can benefit from Oraya Therapy for wet AMD. There is a large patient population that does not respond well to anti-VEGF monotherapy, and our aim is to offer these patients in Germany an additional option to maintain their vision and also decrease the burden of frequent injections," said Oraya Therapeutics CEO Jim Taylor. "We are well positioned with our IRay system at major university eye clinics in Germany, and will continue to expand our presence to make the therapy available to the patients who qualify and elect to pursue this alternative."

The full opinion, titled "Stellungnahme von DOG, RG und BVA zur Strahlentherapie bei neovaskulärer altersabhängiger Makuladegeneration" is accessible within the German Ophthalmological Society website at:  http://www.dog.org/wp-content/uploads/2015/10/Stellungnahme-RG-DOG-BVA-zur-Strahlentherapie-bei-neovaskul%C3%A4rer-altersabh%C3%A4ngiger-Makuladegeneration.pdf.

The IRay Radiotherapy system is a CE marked medical device. In the U.S., the IRay system is an investigational device and is not yet available for sale.

For any of you reading this for the first time, please refer to my original full report describing the IRay system: Oraya IRay In-office Stereotactic X-ray Treatment for AMD: A First Report, written in January 2009.


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