FDA Approves Ranibizumab Prefilled Syringe for Diabetic Retinopathy

The US Food and Drug Administration (FDA) has approved ranibizumab injection 0.3 mg prefilled syringe (Lucentis) as a new method to administer the therapy to all forms of diabetic retinopathy (DR) in people with or without diabetic macular edema (DME).

The approval of the injection therapy from Genentech came April 2017, when it became the first and only FDA-approved therapy for all forms of DR in people with or without DME. The prefilled syringe options are now approved by the FDA for all use in all of Lucentis’ indications.

With the approval, the 0.3 mg prefilled syringe becomes the first syringe with anti-vascular endothelial growth factor (VEGF) agent approved by the FDA for use to treat DR and DME.

Ranibizumab is a vascular endothelial growth factor (VEGF) inhibitor that is designed to bind to and inhibit the VEGF-A protein from forming new blood vessels and causing hyperpermeability in the vessels. Aside from DR and DME, it is currently approved as Lucentis for wet age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO), and myopic choroidal neovascularization (mCNV).

It is approved for such indications in 110 countries.

DR, the current leading cause of blindness among adults aged 20-74 years in the US, currently affects approximately 7.7 million Americans.

“Diabetic retinopathy is a serious condition that affects millions of people in the U.S.,” Sandra Horning, MD, chief medical officer and head of Global Product Development, said in a statement. “Today’s approval of the Lucentis 0.3 mg prefilled syringe reinforces our commitment to advancing therapy for those impacted by this vision-threatening disease.”

According to 1-year interim results of the phase 4 RIVAL study presented last September, ranibizumab has comparable performance to aflibercept (Eylea) in treating patients with neovascular wet AMD. In comparing 278 patients randomized to a treat-and-extend-treatment regimen of 0.5 mg ranibizumab and 2.0 mg aflibercept, researchers found the former arm improved patients’ vision by an average of 7.1 letters, versus the latter’s improvement of 4.9 letters (P =0.063) at 12 months. Both groups received the same number of injections.

However, there have also been administration-based criticism to come of anti-VEGF therapies, including ranibizumab, aflibercept, and bevacizumab (Avastin). A study in 2017 found the therapies, when used to treat neovascular AMD, are susceptible to interruptions to scheduled doses. The recommended administration rates for the therapies are commonly unfollowed, and researched intervals between successive injections for patients of the 3 therapies was typically longer than its pivotal trial results.

Researchers concluded there remains an “unmet need for extended-duration treatments for nAMD.”

Another 2017 study reported that, of 300 studied patients given anti-VEGF therapy for wet AMD, 56% reported feelings of anxiety related to the injection therapy administration.

“Development of new intervention tools, at both the patient and clinical level may reduce psychological symptoms and improve the well-being of patients receiving anti-VEGF treatment," researchers noted.