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    Glaucoma experiences transformative growth as a subspecialty

    Renaissance features innovative diagnostic and therapeutic tools to improve disease management

     

    Recent drug approvals

    Although most recent glaucoma innovations have been in the surgical sector, there are novel classes, particularly the rho kinase inhibitors, that will be available soon. There are also numerous drug-delivery vehicles under development, but progress in this space has been slower than expected.

    Another force contributing to glaucoma’s renaissance has been the tremendous ophthalmic leadership at the FDA, Dr. Singh said. Malvina Eydelman, MD, director, Division of Ophthalmic and Ear, Nose and Throat Devices, and Wiley Chambers, MD, deputy director, Division of Transplant & Ophthalmology Products at the FDA’s Center for Drug Evaluation and Research, have provided insight on what is required to  expedite innovation. Both have been active participants in major ophthalmic conferences as well as other initiatives. Dr. Singh added.

    Dr. Singh provided the example of a workshop prior to the 2014 American Glaucoma Society meeting. During that workshop, glaucoma physicians discussed guidelines for MIGS clinical trials with Dr. Eydelman’s team at the Center for Devices and Radiologic Health (CDER). The following year, the FDA published a leap-frog guidance document to provide a roadmap for innovators in the MIGS field.

    The collaboration also funded a bicoastal initiative through the Centers for Excellence in Regulatory Science and Innovation (CERSI) at the Johns Hopkins University and the University of California, San Francisco/Stanford University to develop patient preference and patient-related outcome tools that allow patients to be heard in the innovation process.

     

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