- Clinical Trials
- Research News
- Industry Trends
- Agency Actions
- Drug Safety Issues
- Approvals, Launches, & New Indications
- Health Care Reform
Positive Phase II Data Reported for Eye Drug Lampalizumab in Advanced Macular Degeneration
Geographic atrophy reduced at 18 months (August 27)
Positive results have been reported from a phase II study of lampalizumab (anti-factor D; Roche) in patients with an advanced form of dry age-related macular degeneration (AMD).
The drug showed a 20.4% reduction rate in the area of geographic atrophy (GA) at 18 months. No unexpected or unmanageable serious adverse events were observed.
The new data were presented at the 31st Annual Meeting of the American Society of Retina Specialists in Toronto, Canada.
AMD is a leading cause of blindness in adults over 55 years of age in the developed world. There are two forms of AMD: neovascular or wet AMD and dry AMD. GA is the advanced form of dry AMD and is characterized by the irreversible loss of retinal tissue in the macula, which results in permanent blind spots in a patient’s central vision.
GA affects more than 8 million people worldwide. While therapies have become available for wet AMD, there are no approved treatments for people with GA. MAHALO is the first study to show a beneficial treatment effect with a complement inhibitor in GA. The efficacy of lampalizumab was observed beginning at month 6 and was maintained through month 18.
Lamaplizumab is an antigen-binding fragment (Fab) of a humanized, monoclonal antibody directed against complement factor D. Complement factor D is a rate-limiting enzyme involved in the activation of the alternative complement pathway (ACP). The ACP is a component of the immune system’s natural defense against infections. Genetic polymorphisms as well as hyperactivity of the ACP have been implicated in the development of AMD, including GA.
Source: Roche; August 27, 2013.