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Lucentis approved for use in United States
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SOUTH SAN FRANCISCO, Calif. — The Food and Drug Administration approved Lucentis for treatment of wet age-related macular degeneration on Friday, following a 6-month priority review.
According to a press release from Genentech, Inc., developers of Lucentis (ranibizumab), 95% of patients treated with the drug maintained vision in phase 3 clinical trials. About 40% of patients had vision improvement by at least three lines at 1 year, and up to 40% of patients achieved vision of 20/40 or better, the release said.
“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,” Eugene de Juan, MD, said in the press release. “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.”
The FDA approval was based on data collected from two large phase 3 clinical trials, the MARINA and ANCHOR studies, the release stated. In the MARINA study (Minimally Classic/Occult Trial of the Anti-VEGF Antibody Ranibizumab In the Treatment of Neovascular AMD), patients experienced an average improvement of 6.6 letters from baseline at 2 years, compared to a loss of 14.9 letters in the sham group.
In the ANCHOR study (Anti-VEGF Antibody for Treatment of Predominantly Classic Choroidal Neovascularization in AMD), patients on average experienced an 11.3 letter gain from baseline at 1 year, compared to a loss of 9.5 letters in patients treated with photodynamic therapy, the release stated.
The most common adverse reactions in the trials included conjunctival hemorrhage, eye pain, vitreous floaters, increased IOP and intraocular inflammation. Serious adverse events, including endophthalmitis, retinal detachments and traumatic cataracts, occurred in less than 0.1% of patients who received the injections, according to the release. The drug is contraindicated in patients with hypersensitivity and ocular or periocular infections, the release stated.