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Latanoprostene bunod once daily found noninferior to timolol three times daily
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Researchers found that daily evening treatments of latanoprostene bunod were noninferior to timolol twice daily for 3 months and resulted in significantly greater IOP lowering in subjects with open angle glaucoma or ocular hypertension, according to a study in the American Journal of Ophthalmology.
This phase 3 study compared the IOP-lowering effect of latanoprostene bunod (LBN) 0.024% instilled once daily in the evening with timolol maleate 0.5% instilled twice daily in those with open angle glaucoma (OAG) or ocular hypertension, at 46 U.S. sites.
The primary efficacy endpoint was IOP in the study eye measured at the time points of 8 a.m., 12 p.m. and 4 p.m. at each post-randomized visit of week 2, week 6 and month 3.
Mean IOP was significantly lower in the LBN group than in the timolol group at the majority of timepoints measured, according to researchers.
LBN was also considered statistically superior over timolol at all time points except the 8 a.m. time point at week 2.
The LBN group exhibited consistently higher IOP reduction of at least 25% at all time points compared with the timolol group.
In addition, LBN treatment resulted in a greater overall reduction in mean diurnal IOP than timolol 0.5% over the course of the study, the researchers wrote.
“LBN was well tolerated overall and exhibited a safety profile typical of topical prostaglandin analog therapy,” they concluded. – by Abigail Sutton
Disclosure: Medeiros received institutional grant money from the National Eye Institute, Allergan, Alcon and Bausch + Lomb and has also served as a paid consultant for Allergan, Alcon, Reichert, Carl Zeiss Meditec and Heidelberg Engineering. Please see the full study for all remaining authors’ relevant financial disclosures.
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Blair Lonsberry, OD, FAAO
Latanoprostene bunod (LBN, Bausch + Lomb), upon contact with the ocular environment, is rapidly metabolized into latanoprost acid, and butanediol mononitrate (a nitric oxide donating compound). Butanediol is believed to provide an additional IOP-lowering effect via relaxation of the trabecular meshwork and Schlemm's canal, increasing aqueous humor outflow.
In this study, the authors determined that daily use of LBN was noninferior to timolol 0.5% twice daily and resulted in significantly greater IOP lowering. Clinical trials for new IOP lowering compounds traditionally use twice daily dosing of timolol as the “gold standard.” How does this compare to the clinical gold standard of a prostaglandin analog?
Clinical trials of LBN vs. latanoprost in animal and human test subjects have demonstrated an additional IOP lowering (1.2 mm Hg) of LBN over latanoprost. For every 1 mm Hg lowering of IOP, it is commonly reported there is an approximately 10% reduction in glaucoma progression.
This compound will potentially give clinicians the proven track record of latanoprost with the additional IOP-lowering effect of a nitric oxide donating compound. With the trabecular meshwork representing the majority of outflow from the eye, it makes sense to try to maximize this pathway in lowering IOP.
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