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    Second pivotal trial confirms IOP-lowering efficacy of first-in-class agent

    Latanoprostene bunod demonstrates superiority to timolol in primary, secondary endpoints

     

    Take-home message: Results from a second pivotal trial investigating latanoprostene bunod 0.024% (LBN) are consistent with another identically designed study showing that not only is LBN non-inferior to timolol maleate 0.5% for lowering IOP, but it has significantly greater efficacy.

     

     

    San Diego—Once-daily treatment with latanoprostene bunod (LBN) 0.024% ophthalmic solution (Bausch + Lomb) is safe, effective, and well-tolerated for lowering IOP in patients with open-angle glaucoma and ocular hypertension. That’s the affirmation from published results of a second phase III clinical trial.

    Data from the LUNAR study investigating the novel nitric oxide-donating prostaglandin F2α analogue were published online in the American Journal of Ophthalmology on May 19, 2016, and are consistent with findings from the phase III APOLLO study that appeared online ahead of print in Ophthalmology in February 2016.

    Both double-masked trials randomly assigned adults with open-angle glaucoma or ocular hypertension 2:1 to treatment with LBN in the evening plus vehicle in the morning or twice daily treatment with timolol maleate 0.5%.

    Follow-up visits were scheduled after 2 weeks, 6 weeks, and 3 months, and IOP measurements were obtained at 8 a.m., 12 p.m., and 4 p.m. at each visit.

    The primary objective of the studies was to demonstrate the non-inferiority of the mean IOP-lowering effect of LBN to timolol over the 3-month treatment period. If that endpoint was met, statistical superiority of LBN to timolol was evaluated as a secondary objective.

    LBN met the primary and secondary objectives in both studies, and the review of adverse event data and vital sign measurements showed no unexpected safety concerns associated with its use.

    LBN is thought to increase aqueous humor outflow through a dual mechanism, according to Felipe A. Medeiros, MD, PhD.

    “It is rapidly metabolized upon instillation in the eye to latanoprost acid, a prostaglandin analogue that increases uveoscleral outflow, and nitric oxide, an important physiological signaling molecule that regulates aqueous humor outflow through the trabecular meshwork/Schlemm’s canal pathway,” he said.

    Dr. Medeiros is professor of ophthalmology, University of California, San Diego, and lead author of the published paper reporting results of the LUNAR study.

    “If approved, LBN would be the first nitric oxide-donating prostaglandin analogue on the market and would be a welcome addition for offering a new therapeutic alternative for ophthalmologists and their patients with open-angle glaucoma or ocular hypertension,” he said.

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