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Cover Focus | July/Aug '20

The Innovator’s Experience

Ophthalmologists share their memorable moments and insights into the pursuit of innovation.

Sean McCafferty, MD, MS, FACS
Developer of the CATS Reusable Tonometer Prism (CATS Tonometer) and 2019 ASCRS Winning Pitch Challenge Finalist

CAN YOU TELL US ABOUT HOW YOU CONCEIVED OF THE IDEA FOR THE CATS TONOMETER?

The CATS Reusable Tonometer Prism (CATS Tonometer) was conceived as a solution to the daily observed clinical problem of inaccurate Goldmann applanation tonometry and the nagging question: “After 60 years, why can’t we make Goldmann better?”

Traditional Goldmann tonometer prisms work by applanating the cornea flat; this approach produces significant error because it also measures intracorneal stress in addition to the IOP. Traditional Goldmann prisms can also create significant IOP error due to subjective cornea centration of the mires. The CATS Tonometer Prism was designed with an innovative and uniquely patented dual-curved surface that cups the cornea and effectively nullifies the corneal stress IOP measurement errors caused by corneal biomechanics and corneal thickness. Also, the CATS Tonometer Prism centration indication feature ensures the mires are centered on the corneal apex improving IOP accuracy.

WHAT HAS BEEN THE BIGGEST HURDLE YOU HAVE FACED SO FAR IN TAKING THIS IDEA FROM BENCH TO BEDSIDE? AND THE MOST MEMORABLE MOMENT?

Every day is a challenging adventure, with little wins and big wins. The process is what makes it fun, and it is only over when you sell the company or the intellectual property—then it is time to reinvent.

CAN YOU OFFER ADVICE FOR YOUNG OPHTHALMOLOGISTS WHO ARE INTERESTED IN PURSUING OPPORTUNITIES FOR INNOVATION?

Have fun! As Helen Keller once said, “Life is either a daring adventure or nothing at all.” Results are the driving endpoint, but it is important to enjoy the process and the way in which it changes you and the world around you.

Be creatively prolific. Let your ideas flow, even the crazy ones, and listen to others’ crazy ideas. Always thinking and listening to creativity can spawn genius. Don’t dismiss ideas out of hand, and write them down!

Prepare yourself and be a great doer. Potentially great ideas die in people’s imaginations and in journal articles, and they are often realized only by great doers. Making a lasting change in ophthalmic practice patterns is 99.9% perspiration, and you must never quit. This is your idea! Make it a reality with a religious fervor.

Be adaptable and know your limitations. Realize where your goal lies but understand that your best-laid plans will almost never unfold as expected. Understand your shortcomings and build a team of individuals with complementary strengths. Let go of the self and utilize the best people to achieve the goal, even if it means you step aside.

Be a great communicator. Instill your vision and your passion in your team. This allows your idea to proliferate and gain acceptance.

Sean McCafferty, MD, MS, FACS
  • Private practice, Arizona Eye Consultants, Tucson
  • CEO of CATS Tonometer, Intuor Technologies, Conexus Lens, and Tantum Optics
  • sjmccafferty66@hotmail.com; Twitter @SeanJMcCafferty

Bala Ambati, MD, PhD, MBA
Developer of IVMED-80 (iVeena Delivery Systems) eye drops for keratoconus and 2019 ASCRS Winning Pitch Challenge Winner 

CAN YOU TELL US ABOUT HOW YOU CONCEIVED OF THE IDEA FOR THE IVMED-80 EYE DROPS?

As a cornea specialist, I regularly see the impact that keratoconus has on patients over years and decades of their lives, as it affects their education, job opportunities, and day-to-day quality of life. Although the standard-of-care epithelial-off corneal crosslinking represents a major contribution to therapy by reducing progression and the future risk of corneal transplantation, the procedure is not curative and still has drawbacks. It was clear that a pharmacologic approach for a chronic disease such as keratoconus would have significant benefit for patients. By understanding the biochemical basis of keratoconus (a deficiency of natural crosslinks in the cornea) and developing an approach that addresses the pathophysiology of the disease by pharmacologic, topical therapy to upregulate lysyl oxidase activity, we came up with the concept for IVMED-80 (iVeena Delivery Systems).

WHAT HAS BEEN THE BIGGEST HURDLE YOU HAVE FACED SO FAR IN TAKING THIS IDEA FROM BENCH TO BEDSIDE? AND THE MOST MEMORABLE MOMENT?

The biggest hurdle so far has been raising money. Through the support of ophthalmologists, angel investors, and family and friends, our startup company, iVeena, has gotten to the point of demonstrating safety and efficacy in a phase 1/2a clinical trial of 33 patients. The most memorable moment so far was when we got the topline results of this study and found zero treatment-related adverse events and efficacy in reducing maximum keratometry (Kmax) by 2.30 D in treated patients relative to placebo over a 6-month observation period.

CAN YOU OFFER ADVICE FOR YOUNG OPHTHALMOLOGISTS WHO ARE INTERESTED IN PURSUING OPPORTUNITIES FOR INNOVATION?

Put together a solid team of individuals who possess talent, experiences, skills, and knowledge; who are smarter than you; who will challenge you and refine the program; and whose goals are aligned with the best interests of patients. Understand that the path is long and arduous, and it requires significant time, money, patience, persistence, and perseverance.

Bala Ambati, MD, PhD, MBA
  • Professor & Director of Ophthalmology and Visual Science, University of Oregon, Eugene, Oregon
  • Founder and President, iVeena Delivery Systems
  • bambati@gmail.com

Sean Iachnulev, MD, MPH
Founder, CEO, Chief Medical Officer, and Director of Eyenovia and Pioneer of Lucentis (ranibizumab, Genentech), intraoperative aberrometry, CyPass Micro-Stent (Alcon), and miLoop (Carl Zeiss Meditec)

WHAT HAS BEEN THE MOST MEMORABLE MOMENT IN YOUR CAREER IN INNOVATION?

My most memorable moment was when Lucentis (ranibizumab, Genentech) was approved by the FDA and I saw firsthand the impact of a breakthrough innovation. The second most memorable is the recall of the CyPass Micro-Stent (Alcon; no longer available)—to remind me how fickle innovation can be.

CAN YOU OFFER ADVICE FOR YOUNG OPHTHALMOLOGISTS WHO ARE INTERESTED IN PURSUING OPPORTUNITIES TO INNOVATE?

Innovation requires casual intensity—persevere and stay on target, but don’t put all of your energy and hopes into it. One can nudge it but not force it. Also, trust your clinical intuition; it is the best guide to determining which ideas are worth developing.

Sean Iachulev, MD, MPH
  • Founder, CEO, Chief Medical Officer, and Director of Eyenovia
  • Professor of Ophthalmology and Head of Innovation and Technology, New York Eye and Ear Infirmary, New York
  • tianchul@eyenoviabio.com
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July/Aug '20