Priority Review Granted for Ocular Disease Drug

The FDA accepted the supplemental Biologics License Application for Lucentis.

The FDA recently accepted Genentech’s supplemental Biologics License Application for Lucentis (ranibizumab injection), granting the drug priority review.

The supplemental Biologics License Application was based on positive results from a phase 3 trial, which examined the use of Lucentis in patients with myopic choroidal neovascularization compared with the FDA-approved treatment, verteporfin photodynamic therapy.

In myopic choroidal neovascularization, abnormal blood vessels grow into the retina, and then break and leak blood or fluid into the retina, according to a press release from Genentech. The condition can lead to permanent central vision loss, and occurs mostly in patients between 45- and 64-years-old.

The condition also affects more women than men. Symptoms of the disease include blurred or distorted vision, progression of central vision loss, and trouble distinguishing colors from each other.

The RADIANCE phase 3 trial included 227 patients whose visual impairment was the result of myopic choroidal neovascularization (mCNV). Patients were randomized into the following groups:

  • Group 1: There were 106 patients who received Lucentis on day 1, 1 month later, and as needed after that.
  • Group 2: There were 116 patients who received Lucentis on day 1 and as needed after that.
  • Group 3: Included 55 patients who received treatment with verteporfin photodynamic therapy on day 1, and received Lucentis or verteporfin photodynamic therapy after 3 months.

At 3 months, patients in group 1 gained 10.5 letters in visual acuity, and patients in group 2 gained 10.6 letters, according to Genentech. In group 3, patients only gained 2.2 letters in visual acuity.

These patients were allowed to receive treatment with Lucentis after 3 months. Researchers said both treatments were well-tolerated, and had limited incidences of serious adverse events, with none occurring in group 3.

The most common side effects relating to the eye include redness, pain, small specks in vision, and increased pressure. Common non-ocular related adverse events include infections, headaches, and nausea.

If the FDA approves Lucentis, it would be the first approved anti-vascular endothelial growth factor therapy for the condition, Genentech reported. In the United States, it is currently approved to treat wet age-related macular degeneration, macular edema after retinal vein occlusion, diabetic macular edema, and diabetic retinopathy in patients with diabetic macular edema.

Lucentis is approved in more than 100 countries for the treatment of patients with wet age-related macular degeneration and diabetic macular edema.

“With the current FDA-approved therapy, people with myopic choroidal neovascularization achieve only temporary stabilization of vision, while mCNV patients treated with Lucentis in the RADIANCE study experienced significant improvement of their vision,” said Sandra Horning, MD, chief medical officer and head of Global Product Development. “The filing acceptance and Priority Review for Lucentis brings us 1 step closer to a potential new option for people with this serious eye condition.”