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    Novel dry eye therapy shows increased efficacy, rapid onset of action

    Nanomicellar cyclosporine formula may expand treatment options; long-term safety to be studied

     

    Performance analysis

    The agent seemed to perform well in the central cornea, which is the area that the FDA considers to have the greatest clinical relevance, Dr. Martel noted.

    In contrast, the OPUS-1 study of lifitegrast (Shire Pharmaceuticals) showed that compared with placebo, lifitegrast did not differ significantly from that of placebo in central corneal staining but did differ significantly inferiorly and superiorly. The OPUS-2 and -3 studies of the drug did not show a trend toward significance in inferior corneal staining when the changes from baseline were evaluated.

    The most commonly reported adverse effect with OTX-101 and cyclosporine is burning upon instillation of the drops, which can affect patient compliance. With cyclosporine, about 17% of patients assigned to the 0.05% and 0.1% concentrations of cyclosporine A reported burning on instillation. In contrast, 1.3% of patients assigned to both OTX-101 concentrations reported severe discomfort.

    In addition, the increased tear production with OTX-101 was seen at 12 weeks compared with that of cyclosporine, which the FDA approved based on increased tear production after 6 months.

    “It is gratifying to see that [OTX-101] is so well tolerated and may soon provide our patients with dry eyes another clinically proven effective treatment,” Dr. Martel said. “I have been very impressed with its clinical efficacy.”

    The FDA directed that one phase III trial be conducted to confirm the significant increase in tear production and the significant decrease in inflammation of the ocular surface compared with placebo resulting from instillation of OTX-101 in the phase IIb/III clinical trial. This confirmatory study has begun, according to a March 3 press release issued by Auven Therapeutics.

    A long-term safety study will be conducted concurrently. The manufacturer anticipates that if these studies are successful, a new drug application will be submitted in 2017.

    More: How to manage cataracts with ocular surface disease

     

    Joseph Martel, MD

    E: [email protected]

    Dr. Martel has no financial interest in the subject matter.

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