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Allergan is launching two clinical trials to evaluate the safety and effectiveness of the drug brimonidine in slowing the progression of retinitis pigmentosa and the dry form of age-related macular degeneration (AMD). In a previous 17-person clinical study of brominidine eye drops at Hadassah-Hebrew Medical Center in Jerusalem, Israel, investigators reported that the drug appeared to preserve the visual field (peripheral vision) for the treated eyes of most participants. In that study, 14 participants had retinitis pigmentosa and three had cone-rod dystrophy. Participants had one eye treated with brimonidine. The other eye was treated with a sham (placebo) eye drop. Neither the participants nor the researchers knew which eyes were receiving treatment or a sham until after the study was completed. Participants were treated for two to three years. Brimonidine is a drug prescribed to lower intraocular pressure in people with glaucoma. Researchers believe it may also release neuroprotective factors that slow the progression of some retinal degenerative diseases. In animal studies, the drug stimulated the production of a potent neuroprotective factor known as brain-derived neurotrophic factor. In the forthcoming studies, Allergan will use a biodegradable ocular implant to provide sustained release of the drug into the eye. A one-year Phase I study for retinitis pigmentosa will include 22 participants at three sites in Germany, Portugal, and France. The trial in France will take place at the Foundation-funded Paris Research Center for the Study of Retinal Degenerative Diseases. The two-year Phase II study of brimonidine for dry AMD will include 95 participants at two sites — Johns Hopkins University in Baltimore, Maryland, and another institution in South Korea. For more information on these studies, visit www.clinicaltrials.gov and search on “brimonidine retina.”
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