SAN FRANCISCO, California — An experimental medication for glaucoma, BOL 303259-X (Bausch and Lomb), lowers intraocular pressure as effectively and safely as the gold standard, latanoprost, and might be more potent, say investigators.
"We found that the optimal dose of the drug produced a significantly greater reduction in intraocular pressure than latanoprost at 28 days, but with a similar side-effect profile," said Robert Weinreb, MD, from the University of California San Diego.
He presented results from a phase 2 clinical trial here at the American Glaucoma Society 23rd Annual Meeting.
"A safe and effective drug that lowers intraocular pressure better than current prostaglandin therapies would be welcomed by both clinicians and patients," Dr. Weinreb noted.
In this phase 2 study, 413 glaucoma patients with a diagnosis of open-angle glaucoma or ocular hypertension were assigned to 1 of 5 treatment groups: once-daily BOL 303259-X 0.006%, 0.012%, 0.024%, or 0.040%, or once-daily latanoprost. All patients were assessed at 7 clinic visits over the 28-day course of treatment, and on the day after treatment ended (day 29).
On day 28, mean diurnal intraocular pressure reduction was greater with BOL 303259-X 0.024% than with latanoprost (9.0 vs 7.8 mm Hg; P = .0051). There was no significant difference in adverse effects between these 2 groups, Dr. Weinreb said.
On day 29, mean diurnal intraocular pressure reduction was still greater in the BOL 303259-X 0.024% group than in the latanoprost group (7.2 vs 6.25 mm Hg; P = .05).
All adverse events were mild or moderate, and rates of conjunctival hyperemia were similar in all treatment groups, Dr. Weinreb noted.
"Based on these data, a phase 3 clinical trial program has been initiated," he reported.
"Since 1996, latanoprost has been the gold standard for treating glaucoma medically because it has fewer systemic side effects than beta blockers," said Andrew Iwach, MD, executive director of the Glaucoma Center of San Francisco in California, who is a spokesperson for the American Academy of Ophthalmology.
"This new drug appears to lower intraocular pressure as well as or even better than latanoprost, depending on the concentration of the drug," Dr. Iwach told Medscape Medical News.
Latanoprost can cause topical complications, so a drug with fewer ocular adverse effects would give clinicians a medication choice that might be better for some glaucoma patients, he noted.
"This study is an important step in the process of finding out whether this drug might be effective and safe for people with glaucoma," Dr. Iwach said.
This study was sponsored by Bausch and Lomb. Dr. Weinreb reports being a consultant for the company. Dr. Iwach has disclosed no relevant financial relationships.
American Glaucoma Society (AGS) 23rd Annual Meeting: Abstract 16. Presented March 2, 2013.
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Cite this: New Glaucoma Drug May Be More Effective Than Latanoprost - Medscape - Mar 28, 2013.