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    Building on cyclosporine for dry eye

    Novel formulation demonstrates early onset of action with favorable tolerability

     

    Currently available topical cyclosporine products, both the 0.05% emulsion available in the United States and the 0.1% cationic emulsion (Ikervis, Santen) that is marketed in Europe, have proven efficacy for the treatment of DED based on results of the registration trials. However, discomfort on instillation, especially in the early period after treatment initiation, is a known problem for both preparations, Dr. Cursiefen told Ophthalmology Times.

    “These products can cause severe symptoms, including burning, itching, and foreign body sensation, that leads to treatment cessation by a not insignificant proportion of patients,” he said.

    “Formulating cyclosporine in the SFA platform, which has high biocompatibility, seems to an effective strategy for improving tolerability.”

    The SFA technology also enables rapid spreading of the dispensed drop over the ocular surface without blinking, thereby minimizing spillover and enabling increased drug delivery.

    Data from ex vivo studies confirm a benefit for increasing the delivery of cyclosporine into ocular tissues compared with the commercially available cyclosporine 0.05% emulsion.

    “Increased bioavailability would be expected to translate into faster onset of action, and so it was interesting that in the phase 2 trial, significant improvements in ocular surface staining were achieved by day 14. In contrast, it generally takes 3 to 6 weeks to see benefit in this objective sign when using other topical cyclosporine formulations,” Dr. Cursiefen said.

    Planning is ongoing for the phase 3 clinical trial program of cyclosporine in the SFA technology.

     

     

    Claus Cursiefen, MD, PhD

    E: [email protected]

    Dr. Cursiefen is a member of Novaliq’s scientific advisory board and an advisor to Allergan and Santen.

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