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    New glaucoma therapy offers first drug option in years

    Latanoprostene bunod increases outflow through the trabecular meshwork and Schlemm's canal

     

    Road to approval

    The prescribing information cites data from clinical studies with up to 12 months duration, in which patients with an average baseline IOP of 26.7 mm Hg were able to achieve IOP-lowering effects of up to 7 mm Hg to 9 mm Hg with once-daily dosing.

    The phase III pivotal studies showed a statistical superiority of latanoprostene bunod to timolol, with a similar safety profile to existing prostaglandin analogues at 3 months.

    Before glaucoma medications are approved in the United States, they must first show non-inferiority before they can show superiority, Dr. Bacharach said.

    “That’s not an easy bar to jump,” Dr. Bacharach explained. “From an efficacy standpoint, Vyzulta appears to be excellent, and what differentiates that improvement in IOP reduction over two of our most commonly used agents is the fact that it combines that efficacy with excellent tolerability.”

    Long-term results were equally impressive, Dr. Bacharach added.

    JUPITER study2 evaluated 121 Japanese subjects with a baseline IOP of 19.6 mm Hg in the study eye and reported a mean IOP reduction in the treated eye of 22% by week 4 that was maintained through week 52. However, at week 52, 9% of treated eyes had an increase in iris pigmentation and the most common adverse events were conjunctival hyperemia, growth of eyelashes, eye irritation, and eye pain.

     

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