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Eylea: Maybe, But Not Yet
I read with interest “When Anti-VEGF Fails in AMD Patients: 3 Treatment Approaches” (Clinical Update, May). Although interesting tactics were described, the discussion of aflibercept (Eylea) omitted a critical point: The phase 3 data supporting its use have not been published. While FDA approval allows the drug to be marketed within its approved indications, a physician’s evaluation of peer-reviewed publications is essential to the practice of evidence-based medicine and sound clinical decision making.
In general, physicians should be cautious in adopting new agents such as Eylea for which there are no published phase 3 studies, particularly given the availability of established treatments such as ranibizumab (Lucentis) and bevacizumab (Avastin), which have excellent efficacy and safety profiles. It is critical to remember that treatment success or failure should be interpreted relative to the natural history of the disease. Incomplete normalization of retinal anatomy on optical coherence tomography may still represent treatment success, and I would hesitate to switch a patient from a drug with established safety and efficacy to an agent without sufficient information. I look forward to the publication of the phase 3 study and hope it advances the care of my patients with wet macular degeneration.
Daniel Will, MD
Dr. Will reports no related financial interests.
Editor’s note: Although the phase 3 trial results have not been published at time of press, the data are posted online at clinicaltrials.gov. Search on “NCT00637377,” click on the study, then select the “Study Results” tab.
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