Late-stage data released from Regeneron highlights the importance of proactively providing Eylea to patients who have been diagnosed with moderately severe to severe non-proliferative diabetic retinopathy (NPDR) in order to prevent issues that could lead to the loss of vision.
Based on data from its Phase III PANORAMA study, Tarrytown, N.Y.-based Regeneron said providing these types of patients with proactive treatments of Eylea (aflibercept) Injection 2 mg reduced “vision-threatening complications” by 75%, compared to patients who were not treated. The vision-threatening complications include the loss of vision, as well as proliferative diabetic retinopathy, anterior segment neovascularization and center-involved diabetic macular edema. In contrast, the study data showed that more than half of the untreated patients in the Phase III trial (58%) developed vision-threatening complications within two years of starting the trial.
Diabetic retinopathy affects about 8 million people and is characterized by microvascular damage to the blood vessels in the retina often caused by poor blood sugar control in people with diabetes.
The results from the study, which were presented this weekend at the Angiogenesis, Exudation, and Degeneration 2020 meeting in Miami, showed a greater benefit for patients treated with Eylea at regular intervals, compared to those who only sporadically received treatment with Eylea. Specifically, the data showed that those patients who received treatment with Eylea every two months benefited the most, Regeneron said. Adverse events remained consistent with the known profile of Eylea, the company said.
Charles C. Wykoff, a retina surgeon and investigator in the PANORAMA trial, said the data reinforces that “regular Eylea treatment” can be effective in reducing the risk of new vision-threatening events among patients with moderately severe to severe non-proliferative diabetic retinopathy. The trial data shows that more than half of the untreated patients developed those vision-threatening conditions, which “underscores the value of treating patients proactively and regularly,” Wykoff said in a statement.
In addition to the PANORAMA results, Regeneron also presented the rationale for use of high dose Eylea in wet age-related macular degeneration. The company is planning to launch a Phase III high-dose trial in wet AMD in partnership with Bayer this year, and another trial in diabetic macular edema.
“Through millions of injections and eight pivotal Phase 3 trials, EYLEA has built a substantial body of evidence and safety profile. High-dose aflibercept will hopefully build on this standard-of-care therapy and represents our ongoing commitment to ophthalmologic research and development,” George D. Yancopoulos, president and chief scientific officer at Regeneron said in a statement. “We are eager to explore the potential of high-dose aflibercept to deliver sustained vision gains and extended duration of action in patients with wet AMD and DME.”
