- Eyecelerator kick off and market update
- ‘Wheels Up’: New product launches
- The Winning Pitch Challenge
- Examining the dry eye landscape
- Exit interview with Wiley Chambers, MD
Eyecelerator kick off and market update
The Eyecelerator program on Thursday kicked off with introductions from Steve Speares, ASCRS Executive Director, Gil Kliman, MD, Eyecelerator Program Director, and John Berdahl, MD, and Julie Schallhorn, MD, Eyecelerator Program Co-Chairs.
Mr. Speares expressed his excitement about the program and for the ASCRS Annual Meeting as a whole. ASCRS is celebrating 50 years of existence, he said. “We have a host of things planned to give you a sense of where we were in 1974,” he said, adding that everyone should be sure to attend the opening session today in Hall C. “Imagine a world where you were not allowed, as a practicing clinical ophthalmologist, to present a paper on intraocular lenses,” he said. “These were foreign bodies. You were either someone who put a foreign body in the eye, or you were a reputable surgeon who took them out.” ASCRS was founded by a bunch of mavericks, he said, surgeons who were dissatisfied with the pace of innovation.
The program also featured a market update. Kristen Harmon Ingenito, with Market Scope, highlighted some of the trends. IOLs are gaining some momentum, she said, and that’s reassuring to see steady growth in a large market like that. She added that there is also a lot of optimism for the glaucoma surgical market, despite reimbursement issues.
One trend that she mentioned was U.S. refractive procedures stagnating and even declining slightly in the past year. There’s a lot that’s happened, she said, and refractive patients are more heavily impacted by challenging economic conditions. Dry eye is another area that has seen a lot of activity. In addition to recalls for a number of OTC drops, there were also several new drug releases last year, which are showing good adoption rates.
‘Wheels Up’: New product launches
“Wheels Up: New Products Attempting to Takeoff” featured discussions on new product launches—early experiences and what the companies are doing to facilitate success.
Aziz Mottiwala, with Tarsus Pharmaceuticals, and Elizabeth Yeu, MD, spoke about the launch of XDEMVY (lotilaner ophthalmic solution, 0.25%, Tarsus Pharmaceuticals), which began in August 2023. Mr. Mottiwala credited XDEMVY’s success so far to a great team, market education efforts, and the value proposition with payers. He said more than 17,000 patients were served in the first quarter, and more than 6,000 eyecare professionals wrote prescriptions for XDEMVY.
Dirk Muehlhoff, with Carl Zeiss Meditec, and Andy Chang, with Carl Zeiss Meditec, spoke about VISUMAX 800 (Carl Zeiss Meditec), which received FDA approval in January. Mr. Chang said that the technology incorporates feedback from experience with the original VISUMAX platform to deliver the SMILE procedure. Some of the new features include a reduced speed for lenticule creation (10 seconds), tech¬nical abilities to correct centration and alignment, and a comfortable surgical experience.
The LAL+ (RxSight) is launching at the ASCRS Annual Meeting, building upon the original Light Adjustable Lens (LAL) platform. The LAL+ adds a small continuous increase in central lens power molded into the anterior surface of the lens. This, Ron Kurtz, MD, with RxSight, said is intended to provide visual benefits before light treatments begin and extends depth of focus relative to the original LAL.
The Winning Pitch Challenge
The Winning Pitch Challenge was back at Eyecelerator, with pitches from three early-stage ophthalmology innovators. Judges and the audience decided who took home cash prizes worth $45,000. The moderators of the session were Vance Thompson, MD, and John Berdahl, MD. Judges included Adrienne Graves, PhD, Richard Lindstrom, MD, Jim Mazzo, Juliet Bakker, and Robert Warner, MBA.
1st Place: InGel Therapeutics, Pierre Dromel, PhD – The aim of this is to bring back light to patients through bioengineered cell therapy, Dr. Dromel said. IGT001 is meant to address the unmet need in retinitis pigmentosa, by repairing and restoring cones for mid-stage disease retinitis pigmentosa. IGT001, a rod-based secretome, competes with a limited number of technologies in mid-stage retinitis pigmentosa, he said.
2nd Place: The LASIK Tonometer, Maria Iglesias, MD, PhD – Dr. Iglesias noted the use of the Goldmann applanation tonometer to measure IOP, but she mentioned how this doesn’t work as well after laser procedures. The LASIK Tonometer aims to fill this gap. This new version was patented by the Barraquer Ophthalmology Center in Barcelona. The LASIK Tonometer has a strong IP platform, with no compe¬tition with the gold standard, she said. There are also more than four clinical trials going on, with several public hospitals and private eye clinics in Spain. There is easy customer adaptation with no learning curve, and it can be sold along with Goldmann applanation tonometry.
3rd Place: TheiaNova Ltd., Carissa Fonseca, PhD – This is a therapy for keratoconus and other corneal ectasias. Dr. Fonseca explained that the company is developing a 3-week, twice daily eye drop treatment that regenerates collagen, restores corneal rigidity, and stabilizes for refractive correction. The treatment is a transforming growth factor β3 plus dexamethasone sodium phosphate. She noted that there has been ex vivo research done in human corneas and in vivo in animals.
Examining the dry eye landscape
Is the dry eye landscape drying out or still fertile ground with opportunities for investors? This is what moderators Robert Dempsey, with AsclepiX Therapeutics, and Preeya Gupta, MD, discussed with panelists Edward Holland MD, Marc Gleeson, with Azura Ophthalmics, Marjan Farid, MD, and Todd Brady, MD, PhD, with Aldeyra Therapeutics, at an afternoon Eyecelerator session.
“Our job is to convince you that dry eye disease is not dead,” Mr. Dempsey said before showing the audience a graphic of the U.S. dry eye total Rx market performance. “What you see here is a healthy market.”
Mr. Dempsey noted that there was $4 billion in topline sales through pharmacies in 2023 and about 5 million prescriptions written in the dry eye space. There has been 6–8% growth in this market. “Ladies and gentlemen, that’s not a dead market.”
Dr. Gupta began a discussion on how a dry eye product gets funded and to market in the current landscape. One word kept coming up among the panelists: differentiation.
“Differentiation is critical,” Mr. Gleeson said. He also said you have to consider what the payer landscape looks like. “Investors look at that endgame from a revenue projection.”
Dr. Brady said that while he’s heard many say, “there are so many products on the market now,” he thinks there is plenty of space.
“It’s not getting smaller, and there is plenty of space for differentiation,” he said.
Building on that, Dr. Holland added that dry eye is a complex condition that needs different mechanisms of action. “There is tremendous unmet need and great opportunity,” he said.
Dr. Holland said later in the session that part of the problem is that “we’ve lumped everything into dry eye.” He said he likes the term ocular surface disease and said those developing therapies and those treating patients need to start segmenting out ocular surface disease based on its different causes (MGD, aqueous tear deficiency, etc.), and stop lumping everything into dry eye disease.
Exit interview with Wiley Chambers, MD
Wiley Chambers, MD, spent 36 years with the FDA before he retired earlier this year from his position as the director of the Office of Specialty Medicine Division of Ophthalmology. Dr. Chambers sat down with John Berdahl, MD, for an exit interview at Eyecelerator.
Among the many questions Dr. Berdahl asked, here are a few.
What do you want to make sure this audience knows about the U.S. FDA that we probably don’t?
Dr. Chambers said the FDA to many people is a black box. “I’ve never fully understood why it remains a black box because it’s been goal of people at the FDA to explain why they were doing particular things. The goal is to get safe and effective products on the market and to have the law behind it … to follow the science behind the law. Personally, the next step for me was to be able to explain why I did something. … And fourth was to try to not be the step holding it up. Get things out as quickly as possible.”
What were you and your team great at at the FDA?
Internally, we could discuss anything and would reach a consensus on any decision that we made, Dr. Chambers said, adding it wasn’t always explainable outside because there was information that couldn’t be shared outside.
What were you not great at?
“Getting around the law when the law made no sense,” Dr. Chambers said to chuckles from the audience.
What are you most proud of?
“I’m proud of giving the ophthalmic community products they can count on to be safe and efficacious,” he said.
“I’d just like to say that 36 years of public service requires an enormous round of applause,” Dr. Berdahl said, concluding his interview as the crowd gave Dr. Chambers a standing ovation.
Editors’ note: The speakers at Eyecelerator have fi¬nancial interests with their associated companies.
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