Latanoprostene Bunod Beats Timolol for Ocular Pressure

Laird Harrison

February 27, 2015

CORONADO, California — In patients with open-angle glaucoma, the experimental drug latanoprostene bunod improves ocular perfusion pressure more than the beta-blocker timolol maleate, and fewer doses are required, according to a new study.

Latanoprostene bunod is "much better than beta blockers, but whether it's better than other prostaglandins" is not clear from these data, said study investigator John Liu, PhD, from the University of California at San Diego.

Dr Liu presented the findings here at the American Glaucoma Society 2015 Annual Meeting.

Latanoprostene bunod is a novel nitric-oxide-donating prostaglandin F2-alpha analog. It is rapidly metabolized in situ to latanoprost acid and butanediol mononitrate.

Nicox and Bausch & Lomb are conducting research on latanoprostene bunod. The companies hope to market the agent as Vesneo for the reduction of intraocular pressure in open-angle glaucoma or ocular hypertension.

Last September, the companies announced that their phase 3 studies met the primary end point of noninferiority to timolol maleate 0.5%. Additionally, latanoprostene bunod showed a reduction in mean intraocular pressure of 7.5 to 9.1 mm Hg from baseline after 2 to 12 weeks of treatment in the two phase 3 studies. This effect on intraocular pressure was statistically superior (P < .05) to timolol in both studies. demonstrated that latanoprostene bunod reduced intraocular pressure during both the day and night, whereas timolol only reduced it at night.

If the data hold, it looks like it's a slightly more powerful medication.

In their study, Dr Liu's team looked at the effect of latanoprostene bunod on ocular perfusion pressure. Previous studies have suggested that ocular perfusion pressure is a risk factor for glaucoma progression because it causes hypoperfusion of the optic nerve head.

Sitting ocular perfusion pressure was calculated as 95/140 times the mean blood pressure minus intraocular pressure. Supine pressure was calculated as 115/130 times the mean blood pressure minus intraocular pressure.

In the 25 patients with open-angle glaucoma or ocular hypertension, intraocular pressure was at least 22 mm Hg in one eye, and at least 36 mm Hg in both eyes.

Patients were randomly assigned to 4 weeks of treatment with one drop of 0.024% latanoprostene bunod ophthalmic solution each evening at 8:00 or timolol 0.5% twice a day.

The patients then switched treatments and continued on the other study drug for another 4 weeks.

Of the 25 patients, one discontinued because of an adverse reaction, two withdrew their consent, and one was lost to follow-up.

During the latanoprostene bunod phase, the mean increase from baseline in daytime sitting ocular perfusion pressure was 3.8 mm Hg (< .01) and in nighttime supine pressure was 2.2 mm Hg (< .01).

During the timolol phase, the mean increase from baseline in daytime sitting ocular perfusion pressure was 2.0 mm Hg, the mean increase in daytime supine ocular perfusion pressure was 2.2 mm Hg, and the mean decrease in nighttime supine ocular perfusion pressure was –1.3 mm Hg.

The difference in the change from baseline between latanoprostene bunod and timolol was significant for daytime sitting and nighttime supine ocular perfusion pressure (P ≤ .02).

Although these findings are promising, they need to be validated, said Dr Liu.

Getting the same or better effects from fewer doses of medication could help glaucoma patients a lot, said Robert Stamper, MD, from the University of California at San Francisco, who was not involved in the study.

"If the data hold, it looks like it's a slightly more powerful medication," Dr Stamper told Medscape Medical News. For some patients, latanoprostene bunod could make the difference "between taking a medication that they are more likely to adhere to and one they are less likely to adhere to."

This study was funded by Bausch & Lomb. Dr Liu has disclosed no relevant financial relationships. Dr Stamper reports that he is principal investigator of a study of a drug made by Aerie Pharmaceuticals.

American Glaucoma Society (AGS) 2015 Annual Meeting: Abstract 15. Presented February 26, 2015.

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