Anthony Wallace of Bausch + Lomb talks about enVista Envy FDA approval

Video Transcript:

Editor's note: The below transcript has been lightly edited for clarity.

David Hutton:

Hi, I'm David Hutton of Ophthalmology Times Bausch + Lomb Corporation announced the FDA has granted approval to the enVista Envy full range of vision IOLs. Joining me to discuss this approval is Anthony Wallace, vice president and general manager of the US Surgical Business for Bausch + Lomb. First off, what distinguishes the enVista Envy full range of vision IOL from the other intraocular lenses on the market, and how does it enhance vision outcomes for cataract patients?

Anthony Wallace:

Yeah, thanks, David. Well, eVista Envy offers a continuous range of vision with excellent dysphotopia tolerance on the widely used enVista platform. In fact, more than 6 million eyes have implanted worldwide with the enVista technology. So surgeons are very comfortable with it. Also, enVista Envy enables surgeons to treat a wider range of astigmatic patients with more accuracy and precision with half diopter or less steps between the cylinder range.

David Hutton:

Can you elaborate on the technology behind the enVista Envy IOL and how it provides a full range of vision, particularly for patients looking to reduce their dependence on glasses after surgery?

Anthony Wallace:

Sure. Well, enVista Envy uses diffractive technology to offer patients that distance, intermediate and near visual acuity. But in our research and development of this lens, we really wanted to rethink diffractive technology, to offer that spectacle independence in all lighting conditions, while reducing those bothersome dysfytopsias that are generally associated with diffractive Technology. The first piece is the use of active syncoptic In INVISTA envy. It's designed to enhance image contrast when patients need it most, evenly distributing light in photopic conditions and prioritizing distance in mesopic conditions. In phototopic conditions, where the pupil size is generally around three to four millimeters. Active syncoptic maintain excellent full range of vision for those patients and in pupils larger than four millimeters, active syncoptic is able to prioritize that light energy which facilitates the night vision. And then, in addition to the active, syncoptic, enVista Envy is enhanced with a proprietary clear path technology designed to reduce light scattering in those patients.

David Hutton:

Tell me a little bit about the clinical trials and patient outcomes that played a key role in securing FDA approval for this IOL.

Anthony Wallace:

Yeah, well, we have 2 large-scale clinical trials. The first one was done in Canada and aligned with the approval of enVista Envy in Canada earlier this year. The US one, specifically, we had 23 investigational sites, more than 1000 eyes implanted with two thirds of those being in enVista Envy. Patients achieve mean visual acuity of 20/20, distance, 20/25, intermediate and j1 near. Most importantly, more than 9 out of 10 patients had little to no bothersome dysphotopsias.

David Hutton:

How do you envision the enVista Envy IOL, impacting the US cataract surgery market, especially in terms of adoption by ophthalmologists and patient satisfaction?

Anthony Wallace:

Yeah, well, you know, starting off top of mind, enVista can treat a broader range of astigmatic patients, and that's something that's not just with Envy, but with our our platform. So, 9 diopters of CIL with half diopter increments or less really enables us to have that precision on patients that they maybe don't have today. There are definitely good options in the market, but we think we can add to that. While the premium IOL market does have good options, as mentioned, for patients today, we believe that it's still an unsatisfied market and and that is, in my opinion, that's defined by the Marketscope data that shows, you know, if you look at it, over the last 8 or 9 quarters, the market's really been flat. This presbyopia correcting, premium market has really been, has been flat to, in some cases, declining. And we feel that enVista Envy can offer spectacle independence with a positive patient experience. So, we believe that envy will give that confidence to surgeons and patients to return back to the premium market.

David Hutton:

And when will these products be available?

Anthony Wallace:

Yeah, so we got approval last week ... last Thursday. We began shipping lenses on Friday and Saturday. So the lenses are available and they're being implanted as we speak.

David Hutton:

What support or resources will Bausch + Lomb provide to surgeons to ensure successful integration of the enVista Envy IOL into their practice. And how does this fit with your broader US surgical strategy?

Anthony Wallace:

Yeah, well, our customer facing team is fully trained, right? They've been learning about this technology. They've been trained on it for the last 3 or 4 months. We also train them at the end of the week last week with approval. But as of this morning, they're out there face-to-face with surgeons supporting them. We also have a full suite of resources that are available online, including our instructions for use, a surgeon brochure, patient brochures. We also have a toric calculator that is that is fully online and ready to go. So, our sales team is out there in full, you know, in full force, and they're really supporting, supporting their surgeons. As far as the question fitting into our strategy, you know, we believe that patients should receive a premium outcome that they truly expect and deserve. In fact, earlier this summer, we acquired Trukera Medical and its ScoutPro point-of-care device for precisely measuring osmolarity. We know that dry eye disease is prevalent in cataract surgery candidates and can have a significant negative impact on outcome. So, being a leader in both in both cataract surgery as well as in dry eye management, we now have the ability to test, treat and offer technology to surgeons and patients to provide that premium outcome. And our goal, really again, is to help them see better, to live better, and we believe that this enables us to do that.