Authors: Wickens, Jason; Blinder, Kevin J.

Source: Drug Safety, Volume 29, Number 3, 2006 , pp. 189-199(11)

Publisher: Adis International

Abstract:

The prevalence of neovascular age-related macular degeneration (AMD) is expected to increase significantly during the next 20 years. New treatment alternatives to laser photocoagulation are on the horizon – the first of these, photodynamic therapy (PDT) with verteporfin, was approved by the US FDA in 2000. In this article we present a preliminary risk-benefit assessment of verteporfin in AMD, focusing on the landmark randomised, double-blind, placebo-controlled studies. The TAP (Treatment of Age-related macular degeneration with Photodynamic therapy) trial established the efficacy of PDT for classic subfoveal neovascularisation in AMD at 2 years follow-up. The VIP (Verteporfin in Photodynamic therapy) study concentrated on subfoveal occult-only lesions not included in the TAP study. After 2 years, treated eyes were less likely to experience visual loss. Exploratory analyses of TAP and VIP suggest that lesion size is a more significant predictor of the treatment benefit than either lesion composition or visual activity. The VIM (Visudyne^® in Minimally classic) trial altered the standard PDT light fluence rate in the treatment of subfoveal minimally classic lesions. This trial again demonstrated a beneficial effect for those receiving treatment with PDT. The VIO (Visudyne^® in Occult) trial, evaluating PDT in occult-only lesions as a confirmatory study of the VIP trial, did not achieve its primary end-point at 2 years. Further analyses are pending.

PDT with verteporfin has an excellent safety profile that has been established with >1 million treatment applications. Cost-effectiveness data are limited but suggest that PDT may be a cost-effective treatment modality. Other FDA-approved treatments (pegaptanib, ranibizumab and bevacizumab) for neovascular AMD are discussed, as well as investigational substances such as anecortave acetate.

Keywords: Age related macular degeneration; Anecortave; Benefit risk assessment; Bevacizumab; Cost effectiveness; Eye surgery; Laser therapy; Pegaptanib; Ranibizumab; Research and development; Various toxicities; Verteporfin; Verteporfin

Document Type: Review article

Affiliations: 1: Barnes Retina Institute, Department of Ophthalmology, Washington University School of Medicine, St Louis, Missouri, USA

Publication date: 2006-01-01

Related content

• In this: publication
• By this: publisher
• In this Subject: Ecology ,  Pharmacology ,  Toxicology
• By this author: Wickens, Jason ;  Blinder, Kevin J.

Website © Publishing Technology. Article copyright remains with the publisher, society or author(s) as specified within the article.

• Terms and conditions
• Privacy policy
• Information for advertisers