Eyeworld

EW NEWS & OPINION November 2015 15 by Eric Donnenfeld, MD, EyeWorld chief medical editor Tear down this wall "M r. Gorbachev, tear down this wall!" This was a highlight in President Ronald Reagan's speech at the Brandenburg Gate near the Berlin Wall on June 12, 1987. President Reagan was challenging Soviet Union leader Mikhail Gorbachev to destroy the Berlin Wall. The Cold War was at its height, and the Berlin Wall separated East and West Berlin. After the wall was demolished, the lives of millions of individuals were changed forever. There is a wall today in ophthal- mology separating the access of new technology from our patients. Earlier this year I attended two internation- al meetings: the European Society of Cataract & Refractive Surgeons meeting in Barcelona and the Australian Society of Cataract and Refractive Surgery in Noosa, Australia. I enjoyed both meetings immensely. These societies are lead by extraordinary individuals, Roberto Bellucci, MD, in Europe, and Graham Barrett, MD, in Australia. Like ASCRS, there is open dialogue, great information, and the free exchange of ideas. The major difference is the topics that were discussed. I heard detailed discussions about technology we do not have access to here in the U.S. Riboflavin UV crosslinking has been around so long in these countries it is consid- ered a standard of care. In the U.S., keratoconus is the second most common reason we perform corneal transplantation, and it is prevent- able. According to the Eye Bank Association of America, 1 in 2012, 7,405 Americans required a pene- trating or lamellar keratoplasty for keratoconus. Approximately 15% of patients with keratoconus will go on to require a corneal transplant. In other words, about 50,000 Ameri- cans developed keratoconus in 2012, many being visually handicapped even if they do not require a surgical procedure. In addition, I heard about artificial irises for patients who have undergone previous surgery or trau- ma and have disabling glare. I also heard about iris clip secondary IOLs for patients who do not have cap- sular support. Several MIGS devices are not available in the U.S. and are being implanted worldwide. At these meetings there were detailed discus- sions regarding dozens of different toric, bifocal, multifocal, and accom- modating IOLs not available in the U.S. Therapeutic and refractive laser vision correction with second gen- eration wavefront and topographic lasers has been available for years and is finally arriving on our shores. The U.S. has historically been the epicenter of great healthcare and healthcare technology. In many areas including ophthalmology, this lead is diminishing, if not gone, and the reason is clear. Taking an extraordinary idea from conception through prototypes, clinical devel- opment, and the maze that is an FDA trial requires organizational skill, leadership, infrastructure, and tens or often hundreds of millions of dollars to complete. Even then, the chances of success are limited. Having worked with the FDA for years, I know that there are extraor- dinary, hard-working individuals there. However, we need to remove the handcuffs that restrain them. The U.S. House of Representatives has passed a bill known as the 21st Century Cures Act that would re- quire the FDA, among other things, to consider more flexible forms of clinical trials and consider patient experience in its review process. Recently, President Barack Obama placed the name of Robert Califf, MD, a leading cardiologist and researcher, to be nominated as the next commissioner of the U.S. FDA. He appears to be a great candidate. In the spirit of President Reagan, I call on President Obama, Congress, and Dr. Califf to tear down this wall and make significant changes in the way the FDA evaluates new medications and devices. EW Reference 1. 2012 Statistical Report, Eye Bank Association of America Contact information Donnenfeld: ericdonnenfeld@gmail.com Eric Donnenfeld, MD Chief medical editor's corner of the world

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