Eyeworld Daily News

41 EW SHOW DAILY 2018 ASCRS•ASOA Annual Meeting, Washington, D.C. retinopathy. It is the first remote diagnostic in ophthalmology in the U.S. and also the first FDA approved artificial intelligence device that per- forms diagnosis without physician input. Dr. Eydelman also stressed that approval was granted in just 85 days. Additionally, she spoke about efforts to improve 510(k) approvals before moving on to discuss options for pre-submission, which facilitates device development/innovation by providing informal FDA feedback, and the Early Feasibility Study Pro- gram, which is meant to encourage innovation in the U.S. by supporting the study of new technology. Approval of an early feasibility study may be based on less non-clin- ical data than would be needed to support the initiation of a larger clinical study on more final device for common chronic disease, more targeted therapies focused on mo- lecular defects, more biologicals vs. small molecules, and more novel platforms, and increased use of path- ways to accelerate development and speed application review. Dr. Stein discussed different pathway options: fast track, which is based upon preclinical or clinical data, or strong rationale; break- through designation, which fea- tures preliminary clinical evidence suggesting substantial improvement; accelerated approval, with a surro- gate endpoint "reasonably likely" or intermediate clinical endpoint; and priority review, where the drug offers significant improvement and could receive a priority review voucher. Utilization of expedited de- velopment and review programs remained high in 2017, he said, noting that almost two-thirds (61%) of the drugs approved in 2017 were approved under priority review. More than one-third (37%) of the drugs approved in 2017 received "breakthrough therapy" designation, he added, and about four out of 10 (39%) of the drugs approved in 2017 received "fast track" designation. Also related to the changing landscape are increased use of patient experience data, use of real world evidence in regulatory deci- sion-making, new drug development tools, innovation in trial design and analysis, and increased focus on generics and biosimilar programs. Dr. Stein spoke about new drug activity in 2017. He ended by discussing changes in the new drug regulatory program. Currently, there is an in-depth review of how we are structured and how we work. There is also a focus on improving effi- ciency, adopting and encouraging innovation, and changes in division and offices in OND. In her presentation, Dr. Eydel- man started by pointing out that medical devices are significantly different than drugs. Both very large and very small companies may be involved. She noted efforts to be transparent and ensure that policies are very clear. Dr. Eydelman specifically discussed efforts in approvals and decreasing the number of days for a device to be approved. She spe- cifically noted the most recent De Novo, which was granted just last week, for the first artificial intelli- gence device that is FDA approved. She said it's "truly a game chang- er for all of medicine, not just for ophthalmology." The IDx-DR (Coralville, Iowa) is intended for use by healthcare providers to automati- cally detect more than mild diabetic retinopathy in adults diagnosed with diabetes who have not been previously diagnosed with diabetic continued on page 42

• Cover