Perspective

Lucentis receives FDA approval to treat myopic choroidal neovascularization

Genentech announced the FDA approved Lucentis for the treatment of myopic choroidal neovascularization, the fifth FDA-approved indication for the drug.

In the phase 3 RADIANCE study, Lucentis (ranibizumab) provided an average visual acuity gain of more than 12 letters for patients with myopic CNV after 3 months of treatment, compared with 1.4 letters for those treated with verteporfin photodynamic therapy. The randomized, double-masked, active-controlled study compared the safety and efficacy of ranibizumab and verteporfin PDT in 276 patients with myopic CNV, according to a company press release.

Patients in the study were randomized into three treatment groups: Two groups received ranibizumab injections guided by prespecified re-treatment criteria, and the third group received verteporfin PDT. Efficacy was comparable between the ranibizumab groups, and adverse events were similar to those in other ranibizumab trials, according to the release.

“With Lucentis, people with [myopic CNV] now have a new FDA-approved treatment option that has been shown to provide a significant improvement in vision in a clinical study,” Sandra Horning, MD, chief medical officer and head of Global Product Development, said in the release.

Lucentis was previously approved to treat wet age-related macular degeneration, macular edema after retinal vein occlusion, diabetic macular edema and diabetic retinopathy in patients with DME.

Genentech announced the FDA approved Lucentis for the treatment of myopic choroidal neovascularization, the fifth FDA-approved indication for the drug.

In the phase 3 RADIANCE study, Lucentis (ranibizumab) provided an average visual acuity gain of more than 12 letters for patients with myopic CNV after 3 months of treatment, compared with 1.4 letters for those treated with verteporfin photodynamic therapy. The randomized, double-masked, active-controlled study compared the safety and efficacy of ranibizumab and verteporfin PDT in 276 patients with myopic CNV, according to a company press release.

Patients in the study were randomized into three treatment groups: Two groups received ranibizumab injections guided by prespecified re-treatment criteria, and the third group received verteporfin PDT. Efficacy was comparable between the ranibizumab groups, and adverse events were similar to those in other ranibizumab trials, according to the release.

“With Lucentis, people with [myopic CNV] now have a new FDA-approved treatment option that has been shown to provide a significant improvement in vision in a clinical study,” Sandra Horning, MD, chief medical officer and head of Global Product Development, said in the release.

Lucentis was previously approved to treat wet age-related macular degeneration, macular edema after retinal vein occlusion, diabetic macular edema and diabetic retinopathy in patients with DME.

    Perspective

    John A. Wells III

    The FDA approval of ranibizumab 0.5 mg for the treatment of myopic CNV represents a considerable therapeutic advance for retina specialists and patients. The only previous FDA approved treatment, verteporfin photodynamic therapy, can achieve anatomic stabilization of myopic CNV but rarely improves vision; in fact, its FDA approval was based on the VIP study results, in which more verteporfin PDT-treated eyes lost less than eight letters of vision (72%) than placebo-treated eyes (44%). In this study, verteporfin PDT eyes gained a median of zero letters at 3 months and one letter at 1 year, with a mean of 3.4 treatments. In contrast, in RADIANCE, myopic CNV eyes treated with ranibizumab guided by the presence or absence of OCT fluid gained a mean of 10.6 letters at 3 months and 14.4 letters at 1 year with a median of two injections. The verteporfin PDT-treated eyes in RADIANCE gained 2.2 letters at 3 months, similar to the VIP results.

    Ranibizumab treatment provides vastly superior vision outcomes to verteporfin PDT for eyes with myopic CNV with a reduced treatment burden and cost for most patients. The FDA approval of Lucentis for myopic CNV gives me a far better treatment alternative for my patients.

    • John A. Wells III, MD
    • John A. Wells III, M.D., retina specialist at the Palmetto Retina Center and Chairman of the Department of Ophthalmology at the Palmetto Health-USC Medical group in Columbia, SC

    Disclosures: Wells reports he a consultant to, on the advisory board of and receives honoraria from Alimera, Bayer, Genentech and Iconic Pharmaceuticals, and an investigator for Aerpio, Alcon, Allergan, Emmes, Genentech, Iconic Pharmaceuticals, Jaeb Center for Health Research, KalVista, Lpath, Neurotech, Ophthotech, PanOptica and Regeneron.