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  • Oraya Therapeutics, Inc.
    Ocular Pathology/Oncology, Retina/Vitreous

    Oraya Therapeutics announced that its IRay Radiotherapy system has received a CE Mark extension for choroidal metastases.

    The radiotherapy system uses a robotically positioned low-energy X-ray source to deliver radiation to the back of the eye in a 15- to 20-minute noninvasive procedure. The stereotactic radiation delivery offers the potential for treatment that does not involve surgery or multiple treatment sessions.

    “I welcome this development because of the opportunity it provides to evaluate this form of radiotherapy in the treatment of certain vision-threatening tumors. If proven effective, this modality would provide a simple and safe alternative to conventional radiotherapy,” said Ian Rennie, MB, ChB, FRCS, a consultant ophthalmologist at the Sheffield Hospitals NHS Foundation Teaching Trust in the United Kingdom who treats ocular cancers.

    Already approved for wet AMD in Germany, the United Kingdom and Switzerland, this extension allows for the expanded indication for choroidal metastases. In the United States, it is an investigational device and not approved by the FDA.