We appreciate Dr Robin's interest in our clinical research on bimatoprost
(formally AGN 192024) and agree that safety is a very important consideration
when selecting a glaucoma medication.
The safety and tolerability of bimatoprost has been demonstrated by
the results of the large, 1-year, pivotal studies for 0.03% Lumigan (bimatoprost
ophthalmic solution; Allergan, Inc, Irvine, Calif). These long-term clinical
data are predominantly used by the Food and Drug Administration in assessing
the safety of a product and form the basis of the product labeling. These
studies included 474 patients treated with bimatoprost once daily for 12 months.
The 6-month data have been published1; the
12-month data were presented at the American Academy of Ophthalmology's 2001
annual meeting and are the source of the safety and tolerability information
in the package insert.2 These results show
that most treatment-related adverse events were ocular or periocular and mild
in severity. The most common adverse events associated with bimatoprost were
conjunctival hyperemia, eyelash growth, and ocular pruritus. After 6 months
of treatment, only 11% of patients had more than mild hyperemia, and only
3% discontinued treatment because of this event. Only 7% of patients taking
bimatoprost discontinued treatment because of any adverse event, which is
not significantly different from the 3.3% of patients who discontinued treatment
in the timolol group. There were no notable systemic findings, and the occurrences
of upper respiratory infection and headaches were comparable in the bimatoprost
and timolol treatment groups.