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Newly approved Alphagan offers primary glaucoma treatment option
IRVINE, Calif. — Allergan will begin marketing its new glaucoma drug Alphagan (brimonidine tartrate 0.2% ophthalmic solution) this month, and the drug will be available nationwide by November, announced company spokespeople.
Alphagan, a selective alpha-2 agonist, treats open angle glaucoma and ocular hypertension by reducing aqueous humor production and increasing uveoscleral outflow. The drug is expected to have minimal cardiovascular and pulmonary side effects.
The Food and Drug Administration has not restricted the drug for use only as an adjuvant therapy, an advantage that Allergan will promote, said Lynn Salo, Allergan's director of marketing for glaucoma drugs.
"The indication for Alphagan is such that physicians can use it where they see fit," Salo said.
Furthermore, Alphagan is labeled for chronic use and is comparable to the gold standard medication, timolol, in terms of lowering intraocular pressure (IOP).
The company has started to gear up its "launch to trade" efforts, which will culminate at the American Academy of Ophthalmology (AAO) meeting in Chicago this month. "We plan on using the AAO meeting as our launch platform," Salo said.
Efficacy without side effects
During clinical trials, brimonidine caused fewer side effects — such as burning or stinging — than timolol, although it did cause more incidents of dry mouth. In clinical trials, researchers administered the drug in a 0.2% concentration twice daily.
Brimonidine sustained its results in clinical trials for periods up to 1 year with no sign of patients escaping the effects of the medication. Because some competing alpha-2 agonists are limited to 3 months maximum tolerance, Allergan will emphasize the product for long-term use, Salo said.
And, said Kevin Burnett, a manager of program development, Alphagan has ocular hypotensive efficacy comparable to timolol, about 4 mm Hg to 6 mm Hg. He added that Alphagan is not contraindicated in patients with cardiovascular conditions, an important advantage over beta blockers.
Salo said Allergan will promote the drug's efficacy as comparable to beta blockers, without the same side effects.
Results compare efficacies
Two studies that were presented at the 1996 Association for Research in Vision and Ophthalmology meeting compared brimonidine with timolol; peak and trough responses were measured.
In one study group of 443 patients randomized to brimonidine 0.2% or timolol 0.5%, peak response was a decrease of IOP ranging from 6.1 mm Hg to 7.3 mm Hg in the brimonidine group, and between 5.3 mm Hg and 6.3 mm Hg in the timolol group.
Trough measurements showed decreased IOP between 4.6 mm Hg and 6.5 mm Hg in brimonidine patients and 6.3 mm Hg to 7.4 mm Hg in the timolol group.
Of the brimonidine patients, 7.7% were cut from the study because of allergic conjunctivitis. Another study reported that 21 of 292 patients, or 7.2%, discontinued brimonidine use after experiencing an ocular allergic response.
A third study compared results of dosing of two times daily and three times daily administration of brimonidine 0.2%. In this study, 101 patients were randomized into a double-masked study and followed for 3 months.
There was no clinically significant difference in ocular hypotensive efficacy between the two regimens at morning trough, and both groups handled the dosing regimen ocularly and systemically, according to the study results.
The most common ocular complaint was blurring, and the most common systemic complaint was oral dryness. One patient was withdrawn from the study due to conjunctivitis.