By Greg Kunst, CEO
A lot of things seem to happen in March – Caesar’s assassination, Shakespeare’s Ides (a fortune-teller’s warning of the aforementioned assassination), the Spring Equinox, and (of course) March Madness.
But Aurion’s most recent March Milestone augurs only good things – especially for the millions of patients around the world who suffer from corneal endothelial dystrophies.
Today we are delighted to announce that on 17 March, we received regulatory approval from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA). We believe this is the first-in-the-world approval of a cell therapy for corneal endothelial disease, and – we hope – the first of many regulatory approvals throughout the world, in the years to come.
You can read about the official news here, but my blog post is a more personal effort. I want to express heartfelt thanks to all of the incredible people who contributed to this milestone:
It starts with the astounding inventions of Aurion’s medical advisory board member, colleague, mentor and friend, Professor Shigeru Kinoshita, MD, PhD, of Kyoto Prefecture University of Medicine. His many years of research, scientific discoveries, publications and clinical work with patients are what made today’s news possible. Professor Kinoshita remains actively involved in our company: he is generous and patient with his time and insights. He is deeply passionate about the potential of this cell therapy to transform the lives of patients around the world. We are so grateful to him, and we benefit from his wisdom and experience in myriad ways.
Our incredible medical advisory board continues to give us pragmatic advice, spirited and opinionated feedback, and to provide thought leadership to the ophthalmology community. In particular, our chair, Dr. Edward Holland and colleagues Elizabeth Yeu, MD, John Berdahl, MD, and Matt Giegengack, MD were brave enough to face down a Cat-4 hurricane in El Salvador in order to perform the world’s first ex-Japan procedures of our cell therapy at the Clinica Quesada in San Salvador. Their brilliant expertise has helped to shape our clinical development strategy, their podium presentations continue to spread the word about cell therapy and we rely on their big brains every day, as we move forward.
When we formed Aurion several years ago, we chose to highlight the values of grit, stewardship and transformation, because we needed to attract people who had those qualities in their DNA. Developing a therapeutic is hard work, most of it entirely unglamorous, painstaking, and requiring limitless, incremental yet critical decisions with far-reaching implications (often not fully understood at the time of decision!). Our employees in the US and in Japan live our values every day. Our Japan team worked – literally – around the clock to prepare the NDA submission to PMDA. They inspire us to make similar progress here in the US and throughout the world. Kudos, Aurion team!
Of course I thank our investors, who are providing the means for our progress. Their strategic oversight, capital and guidance make Aurion Biotech better, and make our work possible.
Finally, March isn’t the only month in the year for Aurion milestones. There is a lot of exciting work going on in our company. I’m very excited about sharing more news in the weeks and months to come, so stay tuned.