Ranibizumab launches new era for web AMD

Retinal specialists have a new therapy in their armamentarium for treating patients with neovascular age-related macular degeneration (AMD).

Retinal specialists have a new therapy in their armamentarium for treating patients with neovascular age-related macular degeneration (AMD).

Jeffrey S. Heier, MD, a vitreoretinal specialist in private practice at Ophthalmic Consultants of Boston, and instructor in ophthalmology, Tufts University School of Medicine and Harvard Medical School, Boston, has been actively involved in the development of ranibizumab as an investigator since the earliest clinical trials.

Carl D. Regillo, MD, director of clinical retina research unit, Wills Eye Hospital, Philadelphia, and associate professor of ophthalmology, Thomas Jefferson University School of Medicine, Philadelphia, has been an investigator in the phase III and IIIb ranibizumab studies.

"Lucentis provides new hope for patients with wet AMD because it is the first therapy to provide a benefit in vision for a significant number of patients," said Arthur D. Levinson, PhD, chairman and chief executive officer, Genentech. "We are proud that the seminal work in angiogenesis conducted at Genentech, years of clinical study, and the dedication and commitment of thousands of patients and retina specialists have all contributed to this important approval."

Substantial database

Ranibizumab is a recombinant humanized IgG1 kappa isotype therapeutic antibody fragment specifically developed for intraocular use. Given by intravitreal injection, the drug binds to and inhibits VEGF-A.

The approval of ranibizumab for the treatment of neovascular AMD was based on efficacy and safety data collected in an extensive clinical trial program, including two pivotal phase III studies: MARINA (Minimally Classic/Occult Trial of the Anti-VEGF Antibody Ranibizumab In the Treatment of Neovascular AMD) and ANCHOR (ANti-VEGF Antibody for the Treatment of Predominantly Classic CHORoidal Neovascularization in AMD). In addition, the FDA reviewed results from the phase I/II FOCUS (RhuFab V2 Ocular Treatment Combining the Use of Visudyne to Evaluate Safety) trial and 12-month data from the phase IIIb PIER (Phase IIIb, Multicenter, Randomized, Double-Masked, Sham-Injection-Controlled Study of the Efficacy and Safety of Ranibizumab in Subjects with Subfoveal Choroidal Neovascularization with or without Classic CNV Secondary to Age-Related Macular Degeneration).