Eyeworld

16 | EYEWORLD | SUMMER 2026 ASCRS NEWS by Susanne Hewitt, MD ASCRS Government Relations Committee Chair GOVERNMENT RETIONS UPDATE corporate spin around these letters/rejections. "This creates more accountability, more trans- parency," he said. Another idea that Dr. Makary questioned was if two pivotal trials are needed for every drug to be approved. "I don't think so," he said. If you think about basic math, you can achieve the same statistical power with a well-con- trolled, well-designed single pivotal trial as you can with two. Dr. Makary noted that it's going to take some time to change this. "We want to," he said, adding that it will be a change to the culture so that when one pivotal trial can be recommended, that's what will be put forth. We want to be competitive with the fierce competi- tion we have overseas right now, he said. Dr. Tarver took to the podium following Dr. Makary to give updates from CDRH. The first thing she acknowledged was that there is so much innovation coming through the doors. Patients are the heart of the work that the FDA does, and we want to make sure they have ac- cess to high-quality, safe, and effective medical devices, she said. Dr. Tarver's two take-home messages were the importance of looking at the agency as a partner in innovation and that they are commit- ted to finding ways that are safe and effective for devices to reach patients who need them. Dr. Afshari led a discussion with Dr. Tarver and Dr. Boyd to close out the session. She asked them about the most impactful product or drug approved in the last 5 years. Dr. Boyd noted several that he thinks have made a big difference, TEPEZZA (teprotumum- ab-trbw, Amgen), Oxervate (cenegermin-bkbj, Dompé), SYFOVRE (pegcetacoplan injection, Apellis), and Izervay (avacincaptad pegol intra- vitreal solution, Astellas Pharma), because these products addressed a gap. For those patients who had no effective therapies, it was remark- able to see the data and see how impactful it was, he said. Dr. Tarver said the most impactful thing she has seen is the ability for IOLs to more naturally resemble a native lens. That has been a huge journey and has opened up a better quality of life for many patients, she said. There has The latest from ASCRS Government Relations continued on page 19 A SCRS Government Relations hosted many activities at the ASCRS Annual Meeting in Washington, D.C., in April. This was a great way for staff and Committee members to interact with and share with physicians, industry, and other attendees the value and importance that ASCRS Government Relations brings to the table. It also allowed Government Relations to highlight ways that we can help you and your practice, as well as the specialty as a whole. From interaction in the Exhibit Hall to the eyePAC Reception to symposia featuring guest speakers to legislative and FDA updates at SightLine at ASCRS and Subspecialty Day, there was a plethora of valuable information and takeaways. We were thrilled to welcome some exciting guest speakers to our symposia. Natalie Afshari, MD, moderated the FDA symposium, which featured former FDA Commissioner Marty Makary, MD, who made remarks and answered questions about recent FDA decisions and the direction he wants to see the agency move. The session also featured Michelle Tarver, MD, PhD, Center Director, Center for Devices and Radio- logical Health (CDRH), and panelist William Boyd, MD, Director of the Division of Ophthal- mology, Office of New Drugs, Center for Drug Evaluation and Research (CDER). Dr. Makary discussed how he's interested in talking about the root causes of the chronic disease epidemic. One thing that brings people together is using scientific objectivity not con- taminated by prejudice or industry influence, he said. He discussed one recent development in making Complete Response Letters public. These outline exactly why a drug isn't approved. The public deserves to know why, and devel- opers, individuals, and academics deserve to understand how a review works, he said. This also enables the drug developers to understand the process with less guesswork. We had the support internally and the legal clearance to release rejection letters, he said, adding that this decision also helps to address any

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