Lumigan is superior to timolol 0.5% dosed twice daily in clinical trials
In particular the FDA warning stated that the promotional letter “lacks fair balance and is misleading because it minimizes important risk information contained in bolded warning in the approved product labeling for Lumigan.” The bolded warning concerns possible permanent changes to pigmented eye tissues, such as increased pigmentation of the iris and periorbital tissue, and increased pigmentation and growth of eyelashes.