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UPFRONT: Giving Context to the Data

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“The ultimate authority must always rest with the individual’s own reason and critical analysis.” – Dalai Lama

Sitting among the many retina specialists at any major meeting, we are inundated with results of clinical trials. Some presentations are overly optimistic despite lukewarm or even negative results. Others are light on details leaving us with more questions than answers.

At the recent American Society of Retina Specialists meeting in Vancouver, British Columbia, I sat next to Wiley Chambers, MD, the deputy director of the Division of Transplant and Ophthalmology Products in the Center for Drug Evaluation and Research at the US Food and Drug Administration. As each presentation unfolded, it was refreshing to hear his incredible insight into the nuances of the clinical trial results we were hearing. Most retina specialists don’t realize the incredible commitment to ophthalmology that Dr. Chambers has made and the debt our profession owes to his consistent, pragmatic decisions over the past 30 years. I learned more listening to Dr. Chambers’ analysis than from any of the presentations. Wouldn’t it be nice if we could always receive this type of insight when new clinical trial results are released?

Toward this end, at Retinal Physician we are incredibly excited to welcome the new “Clinical Trial Download” column, edited by Pravin U. Dugel, MD. In this column, retina KOLs will analyze the results of recently presented or announced clinical trials to put them into perspective. We also hope to get responses from the pharmaceutical companies. While I would love to hear Dr. Chambers’ analysis, for obvious reasons, this is not possible.

The first column will analyze the recent phase 3 clinical trial results with abicipar vs ranibizumab in exudative AMD — the SEQUOIA and CEDAR studies. This long-acting VEGF-A inhibitor offers a true 12-week dosing interval, but the press release was missing key metrics that will hopefully be answered in the first podium presentation in the near future. The press release was analyzed by several KOLs and we received a response to these analysis from the drug company. But as the Dalai Lama appropriately noted, it is your own interpretation and analysis of the results that matter.

We hope you find this very unique column helpful the next time you are sitting in that audience analyzing the podium presentations. RP

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