Lumigan phase 2 clinical trials show promise

Once-daily glaucoma drug lowers IOP as much as the “gold standard,” timolol.

NEW YORK — Phase 2 clinical trials of the glaucoma drug Lumigan (proprietary compound AGN 192024, Allergan) indicate that it may have an advantage over timolol, and that it may be as effective as latanoprost. Jeffrey M. Liebmann, MD, reported on two separate phase 2 trials comparing Lumigan to timolol and to latanoprost here at the Ninth Annual Ocular Surgery News Symposium.

“Lumigan is certainly a good agent for lowering intraocular pressure (IOP),” said Dr. Liebmann, “and it permits excellent compliance and ease of use for the patients with once-daily therapy.”

In comparison to timolol

Lumigan concentrations of 0.03% and 0.01% were compared to timolol in a 30-day trial. Timolol was delivered twice daily and Lumigan delivered once daily for 21 days, and twice daily for the final week of the trial. IOP measurement was the primary outcome variable. “IOP was measured during a variety of pressure measurements, including 14-hour diurnal curves,” said Dr. Liebmann. “There were no demographic differences in the treated groups, and all patients completed the 30-day trial,” he added.

Dr. Liebmann reported a “very significant” reduction of IOP with Lumigan, and at least in this trial there was an improved response compared to timolol. “There was a clinically significant difference in IOP between Lumigan and timolol at all time points measures,” he said.

With the switch at day 22 to twice-daily administration of Lumigan, Dr. Liebmann pointed out, there was not much difference in terms of IOP control. “So when this drug is finally released, it will be released as a once-daily agent,” he said. Timolol is administered twice daily.

He said there were no serious known systemic side effects with Lumigan, but that there was some conjunctival hyperemia and dryness. “There were no significant effects on heart rate or blood pressure, which certainly is good for Lumigan’s systemic profile,” he said. “At least from this study, it seems that Lumigan might be better than timolol.”

In comparison to latanoprost

Lumigan was compared to latanoprost in a 30-day, multi-center study of three groups totaling 60 patients. “Both drugs are very well tolerated, and there really were almost no dropouts, just two in one group and one in the other group,” Dr. Liebmann said. “There was mild conjunctival hyperemia in both groups, and no other change with respect to other safety parameters.”

“I think Lumigan is certainly a good agent for lowering IOP, and it provides excellent diurnal IOP control, which is important for our patients. It permits excellent compliance and ease of use for patients with once-daily therapy, and the safety and tolerability in this small number of patients shows the drug has a favorable safety profile,” said Dr. Liebmann.

There is an IOP reduction of approximately 30% with both of these agents, which is good for achieving a lower target IOP, according to Dr. Liebmann. The diurnal curve on the final day of the study indicates that latanoprost and Lumigan IOPs come fairly close. “A larger number of patients might show that there is a difference,” said Dr. Liebmann. “A large clinical trial comparing these two agents would be required to determine if either of these agents has superior pressure-lowering capabilities.

Compliance implications

Dr. Liebmann described outcomes from the timolol/Lumigan study that could have positive compliance implications. He noted that the patients were checked 2 days after completion of the dosing schedule, and that IOP reduction may last for at least 2 days after the drug is stopped. “I think this has very important implications for patient use and compliance,” said Dr. Liebmann. “If a patient misses a dose, in theory at least from this very limited data, there may not be that much of a loss of IOP control.”

Phase 3 evaluation of Lumigan has been completed, and data were undergoing analysis at the time of Dr. Liebmann’s presentation.

For Your Information:

• Jeffrey Liebmann, MD, can be reached at Glaucoma Associates of New York, 310 E. 14th St., New York, NY 10003; (212) 477-7540; fax: (212) 420-8743. Dr. Liebmann has no direct financial interest in the products mentioned in this article. He is a paid consultant for Pharmacia Corporation and Allergan.