EyeWorld Onsite, May 5, 2023

ASCRS EyeWorld Onsite: ASCRS Annual Meeting, San Diego, California. Reporting from the ASCRS Annual Meeting, May 5-8, 2023

Eyecelerator kickoff sessions: the market, investment opportunities/challenges, and reimbursement

Eyecelerator held its meeting ahead of the ASCRS Annual Meeting, with what ASCRS Executive Director Steve Speares said is a provocative, authentic, and sincere program co-chaired by Julie Schallhorn, MD, and John Berdahl, MD.

Mr. Speares said ASCRS and AAO both share in the need for more innovation. “Our patients need it; our members need it. Ophthalmology has solved some of the world’s biggest challenges and turned them into routine procedures.”

An innovation that can be brought to market and is used around the world on a large scale is what we should be shooting for, said Eyecelerator Program Director Gil Kliman, MD, in his introduction of the meeting.

The session “We Love Ophthalmology, Does Anyone Else?” was meant to look critically at the field of ophthalmology and how it compares to other fields in terms of investments, Dr. Kliman said. The session featured two mini-keynotes from Neha Begwani, Executive Director of Healthcare Investment Banking, Morgan Stanley, and Peter Menziuso, Company Group Chairman of Johnson & Johnson Vision, followed by a Q&A with the panel.

One question Mr. Speares asked Jeffry Weinhuff, Managing Partner of Visionary Ventures, was whether there were categories that, as an investor, “you would roll your eyes, hold your nose, and walk away.” Mr. Weinhuff said there are areas that would be difficult to leap on, such as an IOL product would be costly and difficult to fund. Dry eye assets, he said, would be difficult, too, unless there was something clearly superior or addressing an unmet need. Things that fall into the category of being a disruptive innovation or addressing a large, unmet need are those that will be of interest to investors, he said.

Mr. Speares later asked Cynthia Yee, Principal of Vensana Capital, about devices—whether a new device to remove a cataract, for example, would even be appealing anymore.

“It could be,” she responded but added that it’s hard to innovate in a space that’s already so established. In order to do so successfully, the innovation needs to be more than incremental. “Something that’s fundamentally different both to patients and providers.”

A session moderated by Nathan Radcliffe, MD, took on the topic of reimbursement and when it should be considered in product development. He posed a question to Edward Holland, MD, about the reimbursement landscape from a physician perspective.

“For me, the payers are affecting the way I practice medicine, and I think they’re affecting the way companies look at ‘should I take a risk of trying to bring this drug to market,’” Dr. Holland said, explaining that he might want to offer a patient a therapy that he, as the doctor, thinks is best suited for them, but often to get reimbursed the patient first needs to fail other therapies before moving on.

Dr. Radcliffe later asked Emily Graham, Vice President of Regulatory Affairs of Hart Health Strategics, when companies should get involved with a government affairs lobbyist. She said, early is best.

“It’s incredibly important to start working with Washington and take the blinders off. FDA approval is extremely important and a high bar, … but often we find groups forget about the reimbursement part, making assumptions that the process will be easy,” Ms. Graham said. She added that reimbursement should be considered at the point of selecting endpoints in trials. “Invest early in a government affairs strategy.”

Editors’ note: The speakers have financial interest with their respective companies.

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Wheels Up: New devices attempting 2023 takeoff

A new Eyecelerator session featured commercialization teams from companies ramping up U.S. revenues in 2023. Moderators for the session were Nicole Fram, MD, and Leon Herndon Jr., MD. Four companies were featured in the session.

STAAR Surgical, discussing the EVO ICL, with Warren Foust, Jim Francese, and David Choromanski: Mr. Foust kicked off the discussion, saying that it has been 6 months since the EVO ICL was launched. The most exciting thing is 99.4% satisfaction from patients, and surgeons are satisfied as well, he said. “It’s an adjunct to laser refractive surgery,” Mr. Foust said.

Dr. Herndon asked how this implant is different, noting that ICL had a bit of a “bad name” before. Mr. Foust said the company has heard from customers about concerns around sizing and focused on addressing the sizing component and training for surgeons.

With a new device in the U.S., there are different preop steps needed, Mr. Francese said, adding that STAAR has seen an expansion of its field team and clinical applications and practice development and training teams. “We’re working on educating on sizing and inventory management,” he said.

Mr. Francese said the company sees EVO as an additive procedure. We think EVO can be an important way to make patients happy, grow refractive practices, and we believe we can add patients to the refractive pool that aren’t there today.

Bausch + Lomb, discussing the IC-8 IOL, with Anthony Wallace and Chuck Hess: Mr. Wallace kicked off the discussion on the IC-8 Apthera IOL. One of the challenges we had when acquiring AcuFocus was resources, he said. The Phase 1 launch in the first quarter of the year was a small subset of surgeons who had patients needing this technology. The goal has been to acquire data and experience, he said, adding that additional sales reps and educators have been trained, and the goal is to implant 1,500 lenses in second quarter and try to reach 5,000 patients by end of year.

Mr. Hess said that, when acquiring the technology, Bausch + Lomb saw an opportunity. We saw it as a great opportunity because of reach in over 100 markets globally to take this on and introduce it. “The opportunity we saw with this platform was all the great regulatory work that had been done to have this technology positioned in EDOF space,” he said.

LENSAR, discussing the ALLY femtosecond laser, with Nick Curtis, Alan Connaughton, and Lauren Gyoerkoe: Mr. Curtis noted that the ALLY product is a standalone femtosecond laser that can be put in the OR and is a fraction of the size of current units and can be easily moved. The features of the laser can be utilized no matter what phaco machine surgeons are using, he said.

Ms. Gyoerkoe said that the ability to launch this laser without a phaco machine has allowed surgeons to just replace that laser with this new laser. She added that the ALLY is only 22 inches wide.

Dr. Herndon asked about applications for in-office use, with Mr. Curtis noting that the ALLY would fit well in an in-office surgery environment. It can be moved within 250 degrees of the patient, he said.

Dr. Fram wondered about ophthalmologists losing interest in the femtosecond laser as a category and if this new product will help reenergize the market. Mr. Curtis thinks one reason the technology has lost interest is there haven’t been many upgrades. When designing the ALLY, he said the company looked at drivers as to why people abandoned the femtosecond technology or why they don’t do it in the first place.

Mr. Connaughton added that what differentiates this ALLY device from other devices is its speed, the fact that it can bring the patient in at any angle around the system, and there are many preop devices that can interface with the system.

Glaukos, discussing the iDose sustained glaucoma drug delivery, with Tomas Navratil, PhD, David Haffner, and Cody McKenzie: Dr. Navratil mentioned that the iDose is in the NDA stage and is targeting FDA approval by the end of the year. He added that it is primarily a pharmaceutical. The implant is localized in the corneal angle and is designed to elute over multiple years.

Mr. McKenzie indicated that experienced angle-based surgeons are the clear and immediate opportunity, but he thinks iDose will help expand the market. Dr. Fram asked for explanation on how this product has no effect on the endothelium. Mr. Haffner explained that this is due to the implantation and the nature of how it sits in the corneal angle. It is implanted through a clear corneal incision temporal at nasal side, and two-thirds of the device is in the anterior chamber. When implanted, it naturally sits away from cornea and parallel to iris plane, he said, so there’s a low chance that it’s in contact with the cornea.

Editors’ note: The speakers have financial interest with their respective companies.

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The Winning Pitch Challenge

The Winning Pitch Challenge held another exciting session at Eyecelerator on Thursday. This year, the three presenting finalists were Patricia Buehler, MD, Patrick Gooi, MD, and Barry Linder, MD.

Patricia Buehler, MD, Osheru

Dr. Buehler’s product is aimed at being a minimally invasive surgery for lids. Ziplyft is the device she created, with the goal of making eyelid surgery easier on the patient and the surgeon, expanding the market of surgeons offering lid surgery and the market of patients desiring it, and becoming the leading provider of minimally invasive technology for excess skin removal. The eyelid surgery market is well established and large, she said.

The problem with current lid surgery is it requires an experienced surgeon, can take up to an hour, costs $4,000, there is bleeding requiring cautery and wound closure requiring suturing, there is 2 weeks of bruising and swelling, complications can include wound dehiscence and asymmetry, and there has been little innovation in decades.

Dr. Buehler’s Ziplyft is a patented FDA Class 1 device that features a clear design, allowing the surgeon to see the skin markings of the tissue to be removed. The device fits against the nasal bone to ensure symmetric placement, she said. The serrated jaws compress the skin, sealing it to avoid bleeding and bruising, and a guarded blade cuts and removes the excess skin. The ridge of the skin can be glued, tension free, eliminating suturing.

Surgeon benefits include consistent and symmetric results, reduction in operative time, it’s an in-office procedure, no IV sedation, no need for cautery or suturing, and new cash pay revenue stream, she said. There are also patient benefits including a youthful appearance, improved peripheral vision, minimizing downtime, and patients prefer minimally invasive surgery that provide an improved natural look.

Patrick Gooi, MD, iWick

The iWick is a cutting-edge filtration device for glaucoma. With MIGS, we’re taking a one size fits all approach, he said, but patients in glaucoma come in all shapes and sizes. iWick wants to be a lifetime solution to fit every patient.

Unique features include micro-scale channels, optimized aqueous transportation, pliant and flexible material, over six decades of proven biocompatibility, and it can be used as a standalone device or compatible with other MIGS. He added that you can also connect multiple iWick devices together and use a staged approach.

Five major advantages of the iWick are adjustable reservoir, complete IOP control, enhanced safety profile, plurality of egress paths, and lasting outcomes.

The device can be implanted through small incisions, and there is an existing reimbursement CPT code. We have all the components to get this started and prototyping in humans, he said, adding that the concept has been validated and IP portfolio created. Additional funding from the competition would help star the first in-human pilot study.

Barry Linder, MD, Eyedetec

Chronic dry eye disease management is a big problem, Dr. Linder said. Patients need an affordable, effective, and convenient way to treat dry eye disease, he said. The ELM is the first and only physician-prescribed therapy that treats the root cause of dry eye disease at home, affordably. This is a spa-like treatment for dry eye that uses three components. It uses gentle heating of the eyelids to lower meibum viscosity. Vibration-induced shear thinning of meibum liquifies and mobilizes. It also uses neuromodulation at the nasal bridge that naturally induces lipid expression that’s enhanced due to previous liquefaction.

Patients receive their first treatment in the office and continue at home as directed.

Prizes were awarded based on the judges and audience voting. 1st place ($25,000): Patricia Buehler, MD, Osheru
2nd place ($15,000): Barry Linder, MD, Eyedetec
3rd place ($5,000): Patrick Gooi, MD, iWick

Editors’ note: The speakers have financial interest with their respective companies.

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Additional sessions

Also on the Eyecelerator program was the Eyecelerator Company Case Study, a new series at the meeting that features an in-depth look at companies that survived challenges, ultimately finding commercial success. In the first of this series, moderator James Mazzo, executive chairman of Neurotech, and a panel took a look at Glaukos.

An afternoon session covered first-in-human studies, with a panel of experts from the FDA, academia, biotech, and ophthalmic research.

The final session of the day, “The Closing Bell,” featured presentations of the People’s Choice Awards and honorable mentions for Best of Show Presenting Companies.

Honorable Mention company winners: NeuroTrigger and ViaLase People’s Choice Award #1: Toku
People’s Choice Award #2: LENZ Therapeutics

For further coverage of Eyecelerator, see the Friday edition of the EyeWorld Daily News.

Editors’ note: The speakers have financial interest with their respective companies.

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