May 20, 2004.
FORT WORTH, Texas.
Alcon, Inc. (NYSE:ACL) reviewed data on the RETAANE(R) 15 mg (anecortave acetate for depot suspension) phase II/III study and updated information on two new phase III studies of anecortave acetate at the Association for Vision and Research in Ophthalmology (ARVO) annual meeting in Fort Lauderdale, Fla. In addition, a physician-initiated study of RETAANE(R) with triamcinolone was reviewed at the meeting. RETAANE(R) is being developed by Alcon, Inc. as a treatment for successfully preserving the vision of patients with all forms of wet age-related macular degeneration (AMD). Alcon expects to file a New Drug Application with the U.S. Food and Drug Administration (FDA) in the fourth quarter of 2004. This filing will incorporate data from a current, multi-center, phase III clinical trial comparing RETAANE(R) with photodynamic therapy (PDT) in 530 patients with wet AMD. If approved, the company will begin marketing the product in the first half of 2005.
Phase II/III Clinical Update Presentations at ARVO showed that RETAANE(R) was significantly better than placebo for preserving vision, preventing severe vision loss and inhibiting the growth of all lesion types in patients with wet AMD. At two years, 73 percent of patients treated with RETAANE(R) showed stable or improved vision, while only 47 percent of placebo-treated patients showed a similar vision outcome (p = 0.035). In addition, 94 percent of patients experienced no severe vision loss after two years treatment with RETAANE(R). At twelve months, 79 percent of patients treated with RETAANE(R) had stable or improved vision, while only 53 percent of placebo-treated patients showed a similar vision outcome.
New Phase III Studies
Investigator Stephen Russell, M.D., of the University of Iowa Medical School, Carver School of Medicine, presented an update on Alcon's initiation of two new phase III studies being conducted in groups of patients with advanced dry AMD who are at risk of progressing to wet AMD. The studies will evaluate the safety and efficacy of treatment every six months with anecortave acetate for depot suspension versus a sham procedure. The sham procedure imitates the procedure used to give patients the investigational drug and is a regulatory requirement for keeping the study masked as to which patients receive the drug. Anecortave acetate is the first and only drug of its pharmacological class being investigated to treat this population of at-risk AMD patients. The FDA has granted Alcon "Fast Track" designation for the study of anecortave acetate for this indication because it represents a significant unmet medical need for a serious condition.
Dr. Russell presented the study methods for the new phase III trials. The protocol states that eligible patients must have, or previously have had, wet AMD in one eye, while the other eye has no evidence of exudative AMD or geographic atrophy. Patients enrolled in the trials will be randomized 1:1:1 to administrations every six months for four years of anecortave acetate 15 mg, anecortave acetate 30 mg, or to a sham procedure. To date, approximately 170 patients have been enrolled, out of the total of 2,500 patients for the two studies.
"In the study, anecortave acetate is being evaluated for treatment in arresting the progression from dry AMD to exudative AMD in at-risk patients using an important and clinically relevant measurement criteria, the incidence of 'sight-threatening' choroidal neovascularization, or CNV," said Dr. Russell. "For this study, sight-threatening CNV is defined as fluorescein angiographic evidence of new blood vessel growth under the retina within 2500 microns of the center of the macula."
Physician-Initiated Trial with RETAANE(R) and Triamcinolone
In addition to the phase III information presented, investigator Jason S. Slakter, M.D., of the Manhattan Eye, Ear and Throat Hospital in New York, presented study methods and initial data for a physician-initiated trial evaluating the safety and efficacy of RETAANE(R) 15 mg (anecortave acetate for depot suspension) and triamcinolone acetate 4mg, or a combination of both, in patients with the wet form of AMD.(a) The protocol states that eligible patients must have either subfoveal occult CNV with demonstrated disease progression, or subfoveal minimally classic CNV. The first five patients in this study were treated with a combination of RETAANE(R) -- as the first line therapy -- and an intravitreal injection of triamcinolone acetate 4mg.
The results will serve as a preliminary safety assessment of the combination therapy. When the initial five patients complete the month 3 visit, another 60 patients will be enrolled in a masked study and assigned to receive either RETAANE(R) 15 mg (anecortave acetate for depot suspension) and a sham injection of triamcinolone acetate 4 mg, triamcinolone acetate 4mg and a sham administration of RETAANE(R), or a true combination of the two drugs.
"Given the nature of these two drugs, it is possible that a combination of the agents may provide a synergistic effect, with the strong anti-permeability effect of the steroid combined with the anti-angiogenic effect of anecortave acetate," said Dr. Slakter.
End of article.
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