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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

    Take-home message: The efficacy of a novel dry eye therapeutic may bring a valuable addition to the dry eye armamentarium with a rapid onset of action and better patient tolerability.

    Elk Grove, CA—A newly developed drug for treating dry eye (OTX-101; Seciera, Auven Therapeutics) seems to be a potential beneficial therapy based on the results of a phase IIb/III clinical trial in which the safety and efficacy of the formulation were evaluated.

    Results showed that the two concentrations of the drug were well tolerated and patients had improved tear production and less inflammation by 12 weeks. The future introduction of a new dry eye formulation would be a welcome addition considering the high frequency with which dry eye occurs, according to Joseph Martel, MD.

    Up to 40% of all visits to ophthalmologists are scheduled because patients are seeking help for dry eye symptoms, he noted.

    “Ten to 15 million patients in the United States have dry eye and Sjorgen’s syndrome, the latter of which is associated with dry eye, dry mouth, and inflamed joints, and develops in 1% of the population,” said Dr. Martel, director, Department of Ophthalmology, California Northstate College of Medicine, Elk Grove, CA. “Dry eye is a painful, debilitating disease.”

    Related: How sleep patterns may affect MGD, dry eye

    A number of dry eye therapies have become commercially available recently. However, many of the dry eye drops are palliative and do not address the disease. The efficacy with cyclosporine ophthalmic emulsion 0.05% (Restasis, Allergan) helps some, but many patients cannot tolerate it due to burning and irritation upon instillation, which reduces patient compliance, he summarized.

    Currently, this suggested there is a large number of a patient without effective treatment.

    More: 3 steps to improve ocular health of dry eye patients

    The manufacturer describes OTX-101 as a novel patented nanomicellar formulation of unpreserved cyclosporine that in animal studies of New Zealand rabbits exhibited superior ocular tolerability to that of cyclosporine A. In that study, the tissue distribution of the drug in the cornea and superior bulbar conjunctiva was greater when compared with that of cyclosporine A.

    Phase IIb/III findings

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