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July 2002

An Accurate Comparison of Bimatoprost's Efficacy and Adverse Effects

Arch Ophthalmol. 2002;120(7):1000. doi:

In reply

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.

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