Companies specializing in glaucoma products can make billions of dollars, but only if they can find a path through a minefield of scientific, regulatory, and marketing hazards, according to Richard A. Lewis, MD.
San Francisco-Companies specializing in glaucoma products can make billions of dollars, but only if they can find a path through a minefield of scientific, regulatory, and marketing hazards, according to Richard A. Lewis, MD.
“The amount of money invested in ophthalmology continues to go up,” he said.
Dr. Lewis devoted most of his Drs. Henry and Frederick Sutro Memorial Lecture at the 2016 Glaucoma 360 New Horizons Forum to the pratfalls of glaucoma ventures he has witnessed during a 30-year career.
A former director of glaucoma for the University of California, Davis, and past-president of the American Glaucoma Society, Dr. Lewis now works as a consultant to medical companies and he made a case for the value of his current occupation.
“The role of the clinician-consultant will be very important going forward,” he said.
To succeed in the glaucoma market, a company must not only develop a safe and effective product, it must also assemble a skillful team of leaders, obtain funding, clear regulatory barriers, gain authorization for the relevant procedures to be reimbursed, secure patents, and successful market its product.
As one cautionary tale, Dr. Lewis described the trajectory of iScience, which pioneered techniques for canaloplasty.
After incorporating in 1999, iScience executed its first procedures in the United States in 2002, and raised $37 million in venture capital in July 2008, he said. But then the company wasted valuable time and resources developing ultrasound techniques that proved to be of little clinical value, Dr. Lewis said.
IScience ceased operations in 2012 and sold its assets to Ellex the following year.
“The procedure is still being used,” Dr. Lewis said. “Unfortunately, the company no longer exists.”
2016 Drs. Henry and Frederick Sutro Memorial Lecture
By contrast, Glaukos, manufacturer of the iStent, has adroitly navigated some of the same shoals. Incorporated in 1998, it tried its first procedures in 2003 and secured $150 million in venture capital, winning approval from the FDA in 2012 and reaching $1 billion in valuation in June 2015, Dr. Lewis said.
“No one ever thought a glaucoma company would reach that level,” he said.
Richard Lewis, MD. Courtesy of Glaucoma Research Foundation
Aquesys appears to be following in Glaukos’ footsteps, having secured $90 million in venture capital, he said.
The company hit a regulatory speed bump when the FDA required it to undertake clinical trials without using mitomycin off-label as the company had intended, Dr. Lewis said. It has so far survived through commercialization in Europe, where regulators did not impose the same burden.
“The process for regulatory approval is an interesting chess game,” Dr. Lewis said.
Making sure payers will cover a new device or drug poses the next challenge, he noted.
“You can get FDA approval, but that’s only part of the game because you’ve got to get reimbursement,” he said.
In the ideal situation, after FDA approval the Centers for Medicare and Medicaid Services will authorize reimbursement and private insurers will follow suit. That was the case with trabeculectomy and some drainage devices.
On the other hand, Alcon’s Ex-Press filtration device, canaloplasty, and iStent have all secured reimbursement through Medicare, yet not through Blue Cross or Blue Shield, Dr. Lewis said.
Some products can be successful with FDA approval but without reimbursement from CMS or most private insurers, such as premium toric and multifocal IOLs, Dr. Lewis pointed out.
After working through the regulatory challenges, a successful product launch usually means publishing in peer-reviewed journals, ramping up production, training clinicians to use the new technology, and enlisting the endorsement of key opinion leaders.
Dr. Lewis gave the examples of Thom Zimmerman, MD, Richard Lindstrom, MD, and Ike Ahmed, MD, as “celebrities” within the glaucoma world who have influenced clinicians to use a new product.
However, the field of glaucoma is littered with products that failed to launch, Dr. Lewis said.
He cited ORC’s Orcolon, a 4% polyacrylamide viscoelastic agent. Changes in production after approval resulted in particles embedded in the trabecular meshwork that caused blindness in 10 patients and put the company out of business, Dr. Lewis said.
And when Pfizer launched Xalatan (latanoprost), some patients complained that the bottles were not full. A simple solution would have been to use opaque bottles, Dr. Lewis said.
Despite these glitches, glaucoma products have marched forward over the years, Dr. Lewis said. Milestones of the past 30 years have included the launches of timolol, latanoprost, and the iStent.
On the horizon are Aerie Pharmaceuticals’ Rhopressa and Roclatan, adenosine mimetics, new drug delivery systems, new microinvasive glaucoma surgery (MIGS) devices, neuroprotection, stem cell therapy, and new diagnostic technologies, Dr. Lewis said.
“I’m bullish on glaucoma,” he concluded.
Dr. Lewis has financial interest in Aerie Pharmaceuticals, Alcon Laboratories, Allergan, AqueSys, AVS, Carl Zeiss Meditec, Glaukos, Ivantis, Oculeve, PolyActiva, and Shire.