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Roche's Lucentis Receives FDA Approval for Treatment of Diabetic Retinopathy with Diabetic Macular Edema

Strategic Insights

— 2 min read

The US Food and Drug Administration (FDA) has approved Roche's Lucentis, a vascular endothelial growth factor (VEGF) inhibitor, for the treatment of diabetic retinopathy (DR) with diabetic macular edema (DME). This approval marks a significant milestone in the treatment of DR with DME, a common diabetic eye disease and a leading cause of blindness in American adults under 55. The FDA granted Lucentis Breakthrough Therapy Designation and Priority Review for this indication based on results from the RISE and RIDE Phase III clinical trials. With this approval, people with DR and DME now have a FDA-approved medicine that shows meaningful improvements in retinal damage from diabetes, in addition to established improvement in vision.

Key Takeaways:

  • The FDA has approved Lucentis for the treatment of DR with DME, a common diabetic eye disease and a leading cause of blindness in American adults under 55.
  • The FDA granted Lucentis Breakthrough Therapy Designation and Priority Review for this indication based on results from the RISE and RIDE Phase III clinical trials.
  • The primary outcome in RISE and RIDE was visual acuity gain at 24 months for DME patients.
  • A higher proportion of patients had observed a three-step or better improvement of their disease compared to sham, as determined by color fundus photography.
  • The safety in the RISE and RIDE Phase III trials was consistent with previous studies.
  • The 0.3 mg dose of Lucentis is approved for both DME and for DR in people with diabetic macular edema.
  • Lucentis is a VEGF inhibitor designed to bind to and inhibit VEGF-A, a protein believed to play a critical role in the formation of new blood vessels.
  • Lucentis is FDA-approved for the treatment of wet age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO), DME, and DR in people with DME.
  • Genentech, a wholly owned member of the Roche Group, has conducted eight key clinical trials with Lucentis and has studied the medicine in 21 clinical trials worldwide in more than 9,080 patients.

Statistics:

  • Nearly 750,000 Americans suffer from DME, about 10% of people with DR.
  • Almost 29 million Americans have diabetes.
  • 24 medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials, and chemotherapy.
  • In 2014, the Roche Group employed 88,500 people worldwide, invested 8.9 billion Swiss francs in R&D, and posted sales of 47.5 billion Swiss francs.

Sources:

  • Roche's news release announcing the FDA approval of Lucentis for the treatment of DR with DME.
  • The FDA's website, which granted Lucentis Breakthrough Therapy Designation and Priority Review for this indication.
  • The results from the RISE and RIDE Phase III clinical trials, which demonstrated the efficacy and safety of Lucentis for the treatment of DR with DME.
  • Genentech's website, which provides information on the company's clinical trials and studies with Lucentis.
  • Roche's website, which provides information on the company's vision for ophthalmology and its research in this area.

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