Genentechâ€™s Lucentis granted fifth FDA approval.
Genentech recently announced that the FDA granted approval to Lucentis (ranibizumab injection) 0.5 mg for myopic choroidal neovascularization (mCNV), which results from nearsightedness that can eventually lead to blindness in certain patients.
Ranibizumab injection is the first anti-vascular endothelial growth factor to receive FDA approval for mCNV, according to a press release from Genentech. This most recent approval is the fifth indication ranibizumab injection has received since 2006.
The new approval is based on positive results demonstrated in the RADIANCE clinical trial. This phase 3 study found that patients treated with ranibizumab injection had more significant gains in visual acuity compared with those treated with photodynamic therapy.
Included in the study were 276 patients with visual impairment resulting from mCNV, randomized to receive ranibizumab injections or treatment with photodynamic therapy.
The investigators discovered that the average visual acuity gains for patients treated with ranibizumab injection were at least 12 letters at 3 months, compared with 1.4 letters for patients treated with photodynamic therapy, according to the press release.
Efficacy among different doses of ranibizumab injection was comparable, and adverse events were consistent with ranibizumab injection's established safety profile.
Common adverse effects (AEs) include redness of the eye, eye pain, small specks in vision, increased eye pressure, headache, nausea, and infections of the nose, throat, and lungs. Serious AEs include inflammation of the eye, and cataracts, Genentech reported.
In patients with pathological myopia, the eye grows irregularly, and results in nearsightedness that often leads to mCNV, which is characterized by abnormal blood vessels growing into the retina that can break or leak blood, and cause blindness.
Patients with mCNV experience blurred or distorted vision, worsening of vision, or problems determining colors. Approximately 41,000 individuals in the United States are affected by the condition as a result of pathological myopia.
Currently, Lucentis has received FDA approval to treat patients with wet age-related macular degeneration, macular edema after retinal vein occlusion, diabetic macular edema, diabetic retinopathy in patients with diabetic macular edema, in addition to its most recent approval.
The safety and efficacy of Lucentis has been assessed in more than 9000 patients across 9 pivotal and 24 clinical trials, according to the press release.
Ranibizumab injection is approved for use in more than 110 countries for the treatment of wet age-related macular degeneration, diabetic macular edema, and macular edema resulting from branch retinal vein occlusion, central retinal vein occlusion, and mCNV.
“Myopic choroidal neovascularization often strikes adults in the prime of their lives, and can lead to severe vision loss or blindness,” said Sandra Horning, MD, chief medical officer and head of Global Product Development of Genentech. “With Lucentis, people with this condition now have a new FDA-approved treatment option that has been shown to provide a significant improvement in vision in a clinical study.”