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Fixed combination glaucoma drug receives FDA approval
Nearly a year after regulators requested additional information to prove its efficacy, Allergan’s Combigan has been approved for the U.S. market.
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A new combination glaucoma medication has received U.S. regulatory approval for lowering IOP in glaucoma and ocular hypertension patients.
The U.S. Food and Drug Administration approved Allergan’s Combigan, which combines two already-approved therapies, brimonidine tartrate 0.2% and timolol maleate 0.5%, in late October.
The drug is expected to enter the U.S. market in the fourth quarter, joining Cosopt (dorzolamide HCI, timolol maleate ophthalmic solution, Merck) as the only other glaucoma combination drug available here.
Previously unanswered questions
Allergan had received an approvable letter from the FDA for the drug in December 2006. However, FDA officials requested an additional study to address what they called “certain questions” regarding efficacy.
Allergan had already begun a clinical study at the end of 2005 to address these concerns. The IOP-lowering effect of the drug, when administered twice daily, had been found to be slightly less than that seen with the concomitant use of 0.5% timolol administered twice daily and 0.2% brimonidine administered three times daily, according to the company.
E. Randy Craven, MD, one of the drug’s clinical investigators, told Ocular Surgery News that FDA officials carefully examined twice-a-day dosing results before granting final approval.
“The studies we did showed that Combigan had great efficacy at a twice-a-day dosage,” Dr. Craven said.
The drug, an adrenergic receptor agonist with beta adrenergic receptor inhibitor, reduces IOP in patients with chronic open-angle glaucoma or ocular hypertension who require adjunctive or replacement therapy due to inadequately controlled IOP, according to Allergan.
Combigan is already available in many countries, including Canada, Europe, Latin America, Australia and Korea.
Patient compliance
Dr. Craven said Combigan’s combination of two drugs in one allows patients to take fewer glaucoma drops, thus potentially resulting in better compliance. The regimen also means fewer applications are needed each day.
“It’s a good combination to have available,” he said. “Being in clinical practice and watching what patients go through with multiple drops and multiple bottles, it’s just easier if you have one drop to give twice a day vs. two bottles five times a day.”
“The huge benefit of the drug, as I see it, is just how much easier it is for glaucoma patients today, finally, to be able to use medications that give maximum medical therapy without having to put all these drops in,” Dr. Craven said. “Years ago, people had to have bottles lined up, and they had to live their lives around putting drops in.”
Study results
In 12-month pivotal trials, Combigan was found to reduce mean IOP up to 7.6 mm Hg from baseline. Dr. Craven said the drug was well tolerated and had a lower allergy rate than brimonidine 0.2%.
Clinical studies found that Combigan provided an additional IOP-lowering effect compared with either brimonidine or timolol alone, according to Allergan.
Combigan administered twice a day provided an additional 1 mm Hg to 3 mm Hg decrease in IOP over brimonidine treatment three times a day and an additional 1 mm Hg to 2 mm Hg decrease over timolol treatment twice a day, the company said.
Investigators found that the most common adverse reactions to the drug included allergic conjunctivitis, conjunctival folliculosis, conjunctival hyperemia, eye pruritus, and ocular burning and stinging. Those reactions occurred in approximately 5% to 15% of patients studied.
For more information:
- E. Randy Craven, MD, can be reached at 26 W. Dry Creek Circle, Suite 225, Littleton, CO 80120; 303-797-1900; fax: 303-347-1341; e-mail: ercraven@glaucdocs.com. Dr. Craven is a paid consultant for Allergan.
- Allergan, maker of Combigan, can be reached at P.O. Box 19534, Irvine, CA 92623; 714-246-4500; fax: 714-246-4971; Web site: www.allergan.com.
- Erin L. Boyle is an OSN Staff Writer who covers all aspects of ophthalmology.