Health Canada approves Lucentis (ranibizumab) for myopic CNV

Oct 8 2014

Since its launch in Canada in 2007, Lucentis^® has treated more than 100,000 eyes across all approved indications

Novartis Pharmaceuticals Canada Inc. announced today that Lucentis^® (ranibizumab), 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).

Myopic CNV (mCNV) develops in 5–10% 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, causing 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), 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.

When 67-year-old Harry Tiefenback of Toronto started losing vision from mCNV, he knew it would have devastating effects. "My vision started blurring all the time and was distorted. I'm an artist and painting is my life. I prepared for the worst but did not know how I would pick up the pieces after losing my vision," he said. "When my doctor first told me about Lucentis^®, I had hope. Soon after my first injection, my vision started improving. Today, I'm still painting and doing all the things I want to do. It's made a big difference in my life and for my family."

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 the 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.