Genentech, Inc. received approval from US FDA for Lucentis (ranibizumab injection) for the treatment of neovascular (wet) age-related macular degeneration (AMD). The FDA approved Lucentis after a priority review (six-month).
Nearly all patients (95 per cent) treated with Lucentis maintained their vision in the phase III clinical trials. Vision improved by at least three lines (or 15 letters) on the study eye chart in up to 40 percent of these patients at one year.
Lucentis is designed to inhibit the formation and leakage of new blood vessels in the back of the eye, the primary cause of central vision loss associated with this disease.
"Lucentis provides new hope for patients with wet AMD because it is the first therapy to provide a benefit in vision for a significant number of patients," said Arthur D. Levinson, Ph.D., Genentech's chairman and chief executive officer. "We are proud that the seminal work in angiogenesis conducted at Genentech, years of clinical study, and the dedication and commitment of thousands of patients and retina specialists have all contributed to this important approval."
"In my opinion, the Lucentis approval stands out as one of the most important medical developments in ophthalmology during my 25 years in the field because it has the potential to reverse vision loss associated with wet AMD," said Eugene de Juan, M.D., president, American Society of Retina Specialists. "We are pleased that Lucentis has been approved by the FDA and look forward to working with Genentech to provide retina specialists in the United States with access to Lucentis for patients as quickly and smoothly as possible."
Lucentis 0.5 mg is recommended for intravitreal injection once a month. If monthly injections are not feasible, treatments can be reduced to one injection every three months after the first four monthly injections. Compared to continued monthly dosing, dosing every three months will lead to an approximate five-letter (one-line) loss of visual acuity benefit, on average, over the following nine months. Patients should be evaluated regularly.