Lucentis, anecortave acetate studies recruit for phase 3; early outcomes promising

FORT LAUDERDALE, Fla. — Two promising drugs aimed at stopping the progression of neovascularization in age-related macular degeneration are currently recruiting for phase 3 trials, according to investigators here at the meeting of the Association for Research in Vision and Ophthalmology.

Lucentis (ranibizumab, rhuFab V2, Genentech), an anti-VEGF monoclonal antibody injection, and anecortave acetate (Alcon), an angiostatic cortisene in depot formulation, completed phases 1 and 2 of their early trials with high safety profiles and significant improvements in visual acuity, presenters here told attendees.

“RhuFab continued to produce improvement in visual acuity when administered intravitreally once a month for 6 months,” said Jeffrey S. Heier, MD.

In a study of 64 patients with predominately classic, minimally classic or exudative AMD, Lucentis effectively treated the lesions by evidence of improved visual acuity. Eighty-one percent of patients gained lines of visual acuity at 6 months, Dr. Heier said.

J.S. Slakter, MD, presented outcomes from phase 1 and 2 of the anecortave acetate studies. In a 24 month follow-up period, a 15-mg dose of the drug (administered every 6 months via juxtascleral depot) significantly reduced visual loss from baseline in patients with choroidal neovascularization when compared to placebo.

Patient enrollment for the phase 3 trials for both AMD drugs is under way. The ANCHOR trial, a randomized, multi-center study comparing 0.3-mg and 0.5-mg doses of Lucentis to verteporfin in photodynamic therapy, is currently accepting patients with predominately classic wet AMD. For more information, call Genentech at 888-662-6728. The AART study, a randomized trial evaluating anecortave acetate in high-risk non-exudative patients with AMD, is also accepting patients for its multi-center trial. For more information, log onto www.alcon.com.