Lucentis Approved by Health Canada
Myopic CNV (mCNV) develops in 5–10 per cent of patients with pathologic myopia, which is a leading cause of blindness in many developed countries and second only to wet age-related macular degeneration in causing CNV. Abnormal blood vessels form beneath the retina of the eye and can rupture, leaking blood and fluid into the retina, which causes vision loss. It is estimated that every day, almost five Canadians start experiencing vision loss from mCNV. In patients with untreated mCNV the long-term prognosis is poor, with approximately 90 per cent developing severe vision loss after five years. The condition is more than twice as prevalent in Asian populations as European populations. "The thought of losing your vision can be devastating and the patients I see with this condition are generally young, healthy adults who are working and have a bright future before them. The approval of Lucentis for mCNV equips us as physicians because until now we were only able to slow down vision loss in these patients," said Dr. David Wong, Ophthalmologist-in-Chief at St. Michael's Hospital in Toronto. "Improving vision in these patients allows them to continue working and get on with their busy lives." Lucentis is an inhibitor of vascular endothelial growth factor (VEGF). It is one of the key elements in the formation of new and abnormal blood vessels beneath the retina which cause vision loss associated with both mCNV and the more prevalent condition of wet age-related macular degeneration (AMD). Treatment of vision loss from mCNV with Lucentis starts with a single injection, with further injections as needed, based on disease activity, which is monitored monthly for the first two months, then at least quarterly for up to one year. After the first year, frequency of monitoring is at the discretion of the treating physician. The Phase III study, on which the approval of the new indication was based, showed that treatment with Lucentis was superior to the previous standard of care, Visudyne® (verteporfin PDT). Lucentis improved mean visual acuity by about 14 letters (on an eye chart) after one year. This result was achieved with a median of two injections over 12 months. Over 60 per cent of patients in the trial did not need any further injections after six months. Previous treatments for mCNV aimed to stabilize vision but generally did not improve visual acuity. The treatment for several major causes of vision loss has been approved by Health Canada for the treatment of visual impairment due to choroidal neovascularization (CNV) secondary to pathologic myopia (myopic CNV)
