CONFORMAL RADIOACTIVE PLAQUES FOR INTRAOCULAR MELANOMA

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Radiation is the most frequently used eye and vision-sparing alternative to enucleation of eyes with choroidal melanoma. Brachytherapy, in the form of ophthalmic (radioactive) plaques (OP) is a successful approach for treatment of choroidal melanoma. While preserving vision and minimizing complications, ophthalmic plaque radiotherapy has offered excellent (>92%) local control rates. Current generation ophthalmic plaques, 60Co, 106Ru plates,125I, and 103pd seeds, are less than ideal for dose delivery, have a primitive design, involve antiquated and inefficient manufacturing procedures, and suffer from one or more deficiencies. We propose developing a new ophthalmic plaque based on a charged particle activation process, which allows for manufacturing a broad uniform source, directly embedded in a thin foil. This technology allows for automated custom manufacturing of OPs that match the source intensity to the topography of tumor. Such conformal radiation ophthalmic plaques (CROP) will maximize the tumor dose and minimize the unintentional dose to neighboring radiosensitive tissues. The Phase I application demonstrated feasibility of the process. Tearing arrangements have been made with a leading ophthalmologist and one of the champions of brachytherapy by OP to evaluate the clinical performance of the conformal radiation ophthalmic plaques and demonstrate the success of the project. PROPOSED COMMERCIAL APPLICATION: The market for ophthalmic plaques is small. The U.S. market for such a product is estimated to be around 1500 units/year. There are an equal number of patients overseas. If we assume each plaque uses up to 40 seeds at an average cost of $50 per seed and the associated assembly costs to be approximately $3000, the potential market for new generation OPs is $4,500,000 in the U.S. There is a market of approximately equal size for infants suffering from retinoblastoma where there is a dire need for a thin ophthalmic plaque. There is a sizeable potential market for the OPs for treatment of age related neovascularization.