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    Topical ENaC blocker serves as novel approach to tear film

    First-in-human trial encouraging, identifies agent that is associated with signs of improvement in tear function

     

    Analysis of the tear P-321 pharmacokinetic profile indicated that after 28 days of treatment, average tear concentrations above the half maximal inhibitory concentration (IC50) were observed up to 8 hours after the last administration of the drug. The tear meniscus height measurement after treatment with P-321 showed that compared with placebo the average changes from baseline were significant on days 22 and 28.

    Related: Getting beyond the surface in ocular surface disease

    Dr. Boyer also showed that the changes in the symptom frequency scores and in the severity scores improved significantly with the 0.01% drug concentration.

    Based on these results, study investigators concluded: “P-321 has a favorable safety profile and is well-tolerated at all of the dose levels tested. There was no evidence of systemic exposure of P-321. Levels above pharmacologically effective concentrations in tears were observed several hours after administration of P-321. A treatment effect in favor of P-321 versus placebo was observed in the tear meniscus height. Dry eye symptoms improved with treatment with P-321 for 14 to 28 days.”

    This first-in-human clinical trial to evaluate the safety of an ENac blocking agent for the treatment of dry eye disease “is very encouraging, as it identifies an agent that is well tolerated and associated with signs of improvement in tear function,” Dr. Foulks said. “The use of a topical ENaC blocking agent provides a novel approach to improving the tear film in dry eye disease.”

    Future clinical trials will determine the efficacy of this agent and more comprehensive evaluation of tear function, as well as the health of the ocular surface.

    More: Managing ocular surface disease in patients with glaucoma

     

    José L. Boyer, PhD

    E: [email protected]

    Dr. Boyer is an employee of Parion Sciences Inc.

     

    Gary N. Foulks, MD

    E: [email protected]

    Dr. Foulks is a paid consultant to Parion Sciences Inc.

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