Salvat submits NDA for clobetasol nanoemulsion to treat ocular surgery inflammation, pain
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Salvat Laboratories has submitted a new drug application to the FDA for clobetasol nanoemulsion to treat inflammation and pain after ocular surgery.
The application is supported by two phase 3 clinical trials that demonstrated positive efficacy and safety results for the corticosteroid in more than 400 patients. In addition, there was a low impact on IOP in the clinical trials, according to a press release.
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The therapy demonstrated no rebound effects in the 2 weeks after a standard 14-day course of treatment, with no requirement for a gradual decrease in dosage toward the end of treatment. Additionally, the formulation has shown increased efficacy in absorption and no blurred vision or discomfort after application.
The treatment would be the first ocular corticosteroid formulated in a nanoemulsion and was designed with an advanced automated single-dose vials manufacturing system, according to the release.
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