/ /

  • linkedin
  • Increase Font
  • Sharebar

    Fixed-combination glaucoma agent yields positive safety, efficacy data

    Mercury 1 trial for combination drug finds better results compared with single agents alone

     

    Safety, adverse events

    No new adverse events occurred during the 90-day reported period for Mercury 1. Hyperemia did occur in 60% of patients. Most of those cases were mild as determined by biomicroscopy. The hyperemia that occurred was sporadic.

    “Hyperemia is a common adverse effect and was slightly more frequent at 12 months (63%) than at 3 months (55%),” Dr. Fechtner said. “For reference, hyperemia was reported in 21.9% of subjects using latanoprost.”

    The other adverse events observed during the 12-month trial are consistent with those observed during the initial 90-day efficacy period, including conjunctival hemorrhages and corneal verticillata, according to the company. The occurrence of corneal verticillata, or vortex keratopathy, also has occurred in patients using systemic medications like amiodarone and subconjunctival 5-fluorouracil as an adjunct for glaucoma surgery, Dr. Fechtner said.

    “This is a new adverse effect for an IOP-lowering medication, and the long-term implications are not yet known,” he continued.

    In 60% of patients, the drug reduced the mean diurnal IOP to 16 mm Hg or lower—a significantly higher percentage than what was observed in the two comparator arms.

    The company submitted an NDA for netarsudil (Rhopressa) in February 2017. The FDA has stated that its goal date to complete its review of netarsudil is by the end of February 2018.

    Although the results from netarsudil/latanoprost (Roclatan) are positive, Dr. Fechtner would like to know more about the agent, such as how many real-life patients will not tolerate it due to adverse events and the effects of additivity of other single agents or fixed combinations to the drug.

     

    Robert Fechtner, MD

    E: Fechtner@upstate.edu

    Dr. Fechtner is a consultant or provides research support for Aerie Pharmaceuticals, Alcon Laboratories, Allergan, Bausch + Lomb, Novartis, and Santen.

    New Call-to-action

    0 Comments

    You must be signed in to leave a comment. Registering is fast and free!

    All comments must follow the ModernMedicine Network community rules and terms of use, and will be moderated. ModernMedicine reserves the right to use the comments we receive, in whole or in part,in any medium. See also the Terms of Use, Privacy Policy and Community FAQ.

    • No comments available

    Poll

    View Results