Perspective

FDA approves intravitreal ranibizumab for treatment of diabetic macular edema

The U.S. Food and Drug Administration has approved the use of once-monthly 0.3-mg intravitreal ranibizumab for the treatment of diabetic macular edema, according to a press release from Genentech.

The 0.3-mg dose of Lucentis (ranibizumab, Genentech) was unanimously recommended for approval on July 26 by the FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee. Intravitreal ranibizumab has already been approved by the FDA for the treatment of wet age-related macular degeneration and macular edema following retinal vein occlusion.

In clinical trials, 759 patients were given a 0.3-mg dose of ranibizumab, a 0.5-mg dose of ranibizumab or a sham injection.

Patients who received the 0.3-mg dose demonstrated significant improvements in vision as soon as 7 days after treatment, with more ranibizumab-treated patients than control subjects experiencing an increase in vision of three lines or more by month 24, according to the release. Patients also experienced sustained visual acuity from baseline through 24 months, with continued treatment through 36 months.

The most common ocular adverse events associated with the 0.3-mg injection vs. the sham injection were conjunctival hemorrhage, eye pain, foreign body sensation in the eye, vitreous floaters and increased IOP.

“Diabetes is a major public health issue in our country, and all patients with diabetes are at risk of developing diabetic macular edema,” Renata Albrecht, MD, director of the Division of Transplant and Ophthalmology Products in the FDA’s Center for Drug Evaluation and Research, said in an FDA press release. “[This] approval represents a major development for the treatment of people whose vision is impaired by DME as a complication of their disease.”

The U.S. Food and Drug Administration has approved the use of once-monthly 0.3-mg intravitreal ranibizumab for the treatment of diabetic macular edema, according to a press release from Genentech.

The 0.3-mg dose of Lucentis (ranibizumab, Genentech) was unanimously recommended for approval on July 26 by the FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee. Intravitreal ranibizumab has already been approved by the FDA for the treatment of wet age-related macular degeneration and macular edema following retinal vein occlusion.

In clinical trials, 759 patients were given a 0.3-mg dose of ranibizumab, a 0.5-mg dose of ranibizumab or a sham injection.

Patients who received the 0.3-mg dose demonstrated significant improvements in vision as soon as 7 days after treatment, with more ranibizumab-treated patients than control subjects experiencing an increase in vision of three lines or more by month 24, according to the release. Patients also experienced sustained visual acuity from baseline through 24 months, with continued treatment through 36 months.

The most common ocular adverse events associated with the 0.3-mg injection vs. the sham injection were conjunctival hemorrhage, eye pain, foreign body sensation in the eye, vitreous floaters and increased IOP.

“Diabetes is a major public health issue in our country, and all patients with diabetes are at risk of developing diabetic macular edema,” Renata Albrecht, MD, director of the Division of Transplant and Ophthalmology Products in the FDA’s Center for Drug Evaluation and Research, said in an FDA press release. “[This] approval represents a major development for the treatment of people whose vision is impaired by DME as a complication of their disease.”

    Perspective
    John W. Kitchens, MD

    John W. Kitchens, MD

    “If you drain the Pacific Ocean, don’t be surprised to find that the islands are connected.” – Judah Folkman

    Dr. Folkman’s statement is prophetic when it comes to vascular endothelial growth factor and disease of the eye.

    Diabetes is the leading cause of new cases of blindness in people between the ages of 24 and 70 years. The impact of this disease on people in the prime of their working years is life-altering. Vision is a diabetic patient’s lifeline to not only their independence but also their ability to monitor and treat the very disease that robs them of vision.

    It is astonishing that it has been more than 25 years since the last large randomized controlled trial, the  Early Treatment Diabetic Retinopathy Study, that had a major impact on the way we approach diabetic retinopathy.

    The U.S. Food and Drug Administration approval of Lucentis (ranibizumab, Genentech) for diabetic macular edema is based on the results of the Genentech-sponsored RIDE and RISE studies. These studies not only provided us with another option in the management of diabetic macular edema but also gave us insight into the dosing strategies, retinopathy progression and other important aspects of diabetic eye disease. One very important and often overlooked aspect of these studies is the effect that anti-VEGF therapy has on reducing the progression of retinopathy.

    We have also seen impressive results in the Diabetic Retinopathy Clinical Research Network protocol I study. In the protocol I study, ranibizumab was compared with various other treatment modalities including combination therapy, combination therapy with steroids and laser alone. Additionally, the Diabetes Control and Complications Trial to the Early Treatment Diabetic Retinopathy Study produced strong results that have guided our ability to care for these individuals.

    The same great man quoted at the beginning of this perspective also noted (about cancer): “We never use the word ‘cure’ because it is far away”. The same is true for ranibizumab. It is not a cure for diabetes or its effects on the eye. However, the FDA approval of ranibizumab for the treatment of diabetic macular edema provides a welcome addition to the arsenal of treatment options for our patients with diabetic macular edema.

    • John W. Kitchens, MD
    • Retina Associates of Kentucky

    Disclosures: Kitchens is a speaker and consultant for Genentech and Regeneron.