Peer-reviewed articles on investigational therapies
and a look at how they will affect your practice.
Based on the current understanding that vascular endothelial growth factor
(VEGF) plays a major role in ocular neovascularization, several pharmacologic treatments for wet age-related macular degeneration (AMD) that target VEGF are being investigated.
The articles on the following pages explain the science behind the three
anti-VEGF treatments that are farthest along in the investigation process. The authors review the results of safety and efficacy studies and the clinical trial data available to date. One or more of these treatments could receive FDA approval within a year.
In a fourth article, retina specialists surmise what practical impact these types of treatments will have on day-to-day practice operations and patient management.
Page 16: ranibizumab
(Lucentis), a recombinant humanized antibody fragment. Authors: Stephan Michels, MD, and Philip J. Rosenfeld, MD, PhD.
Reviewers: George Williams, MD, chairman, Department of Ophthalmology, William Beaumont Hospital, Royal Oak, Mich., and Paul Sternberg Jr., MD, George W. Hale professor, chairman, Ophthalmology and Visual Sciences, Vanderbilt University Medical Center, Nashville, Tenn.
Genentech is conducting 2 phase III trials of
ranibizumab. The MARINA trial is evaluating the safety and efficacy of ranibizumab in patients with subfoveal minimally classic or occult choroidal neovascularization
(CNV). The ANCHOR trial is evaluating the safety and efficacy of ranibizumab compared with verteporfin photodynamic therapy in patients with subfoveal predominantly classic
Page 24: anecortave acetate (Retaane), an antiangiogenic synthetic analog of
cortisol. Author: Allen Ho, MD. Reviewers: George Williams, MD and Paul Sternberg Jr., MD.
Alcon has submitted the second of three portions of this "rolling" New Drug Application to the FDA and expects to file the third in the fourth quarter.
Page 34: pegaptanib sodium
(Macugen), a pegylated anti-VEGF aptamer. Authors: Lawrence Singerman, MD, and Joan H.
Hornik, AB. Reviewers: George Williams, MD and Paul Sternberg Jr., MD.
Eyetech Pharmaceuticals has submitted all data to the FDA. The Dermatologic and Ophthalmic Drugs Advisory Committee is scheduled to discuss the NDA on August 27, 2004.
Page 36: Lee M.
Jampol, MD, and Mark W. Johnson, MD, discuss the practical implications of this new category of treatments for AMD.
Retinal Physician, Issue: August 2004