Mazzo Details Plans For Kamra Inlay’s Introduction To The US Following FDA Approval

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Chairman and CEO Jim Mazzo tells how the AcuFocus team went above and beyond to share news of Kamra’s FDA approval at ASCRS, looks forward to US launch.

Podcast Guest

Transcript

Tom Salemi: Hi, welcome back to the OIS Podcast. I’m your host, Tom Salemi. The day after our last OIS on April 17, AcuFocus received a great bit of news from the FDA. The agency approved the company’s Kamra Inlay, giving it the green light to begin selling the Inlay for the treatment of or correction of presbyopia. AcuFocus had been waiting close to a year since an advisory panel approved the device, or recommended approval of the device last June, and now it’s got the approval to go forward. So today we talked with Chairman and CEO Jim Mazzo about the past year and his conversations and the company’s conversations with the FDA. And we also took a look forward to see how AcuFocus will be positioning Kamra in the US. Jim, of course, is a regular and valuable contributor to OIS, moderating our anchor session at the end of the day on April 16. He moderated our Masters of the Universe panel, which included the heads of Alcon, AMO, Zeiss, and Valeant. Jim will look back at this year’s OIS and gives a little sneak peek to what you can expect to hear at our OIS conference in Las Vegas coming up in November. So please enjoy this conversation.

TS: Hi, Jim, welcome back to the Podcast.

Jim Mazzo: Thanks, Tom. Great to be back. Always love having a chance to talk to you.

TS: Great, great, it’s great to have you here. So the reason you’re hear is you had a big of great news. Right after OIS, the FDA approved Kamra, and the timing – was the release of the news timed to ASCRS, or was it just a fortunate coincidence?

JM: I don’t believe in coincidences. The technical timeline that the FDA had with us was mid-May. But I think based on the just tremendous cooperative behavior we’ve had with the FDA over this whole course of getting approval, I think everyone knew how critical it is for the customers to be able to know about this technology. And ASCRS was a perfect medium. So I know my team worked over the Easter break. I know the FDA team worked over the Easter break, so I think everybody did their best to ensure we had this approval by the ASCRS.

TS: Great. I didn’t get over to the floor, but did you have – were you all set up for this, and ready to answer questions from physicians who were there?

JM: Well, you know, it’s interesting. My team here did a fabulous job. We actually had two different booths ready for approval or not approval. We had everything in duplicate form. And so the timing came at 1:00 on Friday. The drop dead time was 3:00 Friday for us to be able to have everything in place. So the stars were aligned. So we were able to execute. And as many colleagues told me that I think we were the busiest booth on the floor for the whole ASCRS, and that includes the large companies as well. So we couldn’t have been more pleased. And again, I will tell you that I have to pay huge compliments to Dr. Edelman, Jeff Shurin. The whole FDA team just throughout this whole process worked with us to get us to this point. They were tough, rightfully so. But really was a very, very cooperative spirit. And since I was involved with the MDUFA 3 negotiations when I was Chairman of Advamed, you know, I knew what Dr. Shurin was trying to do to work with medical device companies, and I think we’re a perfect, shining example of cooperation between company and the government.

TS: That’s outstanding, and kudos to your team. You really had no idea up until 1:00 what was coming your way?

JM: Yeah, 1:00 Friday. That is the honest to God truth. I was sitting in a ASCRS Foundation board meeting and Nick Tarantino called me. I walked out of the meeting and we were going to meet with the industry at 3, and people like yourself and at 4, and then we had to have everything done by 2:00. So it was to the last minute.

TS: That’s terrific. So the advisory panel voted last June, and there was overwhelming support of its efficacy, though there were some questions about safety. That vote came pretty close. In a close vote on whether the benefits outweighed the risk. Tell me what has – what’s transpired over the past eight or nine months or so? What has close to the past year been like?

JM: Well, I think it’s been a lot of hard work by both sides. And I think it goes back to my point: a lot of discussion. I think that’s the big difference now. You know, Novina and her time had a lot of meetings with my team, and I think they were clearly able to see the data. You know, a panel is an interesting exercise. We don’t have enough time on a Podcast to really explain a panel, but it really all depends on who’s on the panel. We really didn’t have a refractive specialist on the panel. So a lot of the questions were around the procedural end of it, which is right, but not as much on the actual science behind it. And I think that’s why we won the vote on benefits outweigh risks, because I think they clearly show that the data was there. Procedurally we had some challenges, and that’s why the open communication between the two groups helped, and that’s what got us to where we are with the approval. And the labeling was what we were looking for as well. And now we have this technology available for the physicians in the US, just like across the globe.

TS: Great. So where are we now? What are you doing in the US? Where is this fitting into the treatment offerings? Is this something that’s presented merely as an alternative to contact lenses or glasses or other non-surgical means? Or does this fit into the more invasive type of procedures?

JM: Actually, I think I like to look at it as a continue on the demographics. If, you know, I want to use very general, but tends to be very specific to the demographics that we all address. If you look at a contact lens wearer, they tend to be about 18 to 35. You know, you’ve got ranges plus and minus. You’ve got a Lasik where Lasik individuals is the average age is about 37. And then you’ve got our cataract patient, who’s about 62 plus. So you really have a gap there from about that 40-year-old to that 60-year old, where the only medium today to a grand degree is glasses. And we’re all challenged by them. I know you wear them, but you wear them on a probably continuous basis. But most of us don’t wear them on a continuous basis, so we have all these readers everywhere. So there really isn’t a replacement other than I would sit there and tell you that the replacement is these frustrating pair of glasses that sit around in our bathrooms, in our hallways, in our offices. And so that’s where it’s fitting. Because there isn’t anything today from a surgical procedure to a grand degree that affects this age group of 45 to 60-year-old.

TS: Yeah, I’m 45. I’m turning 46 in June. And I do wear my glasses, and I’m just starting to have trouble reading with them on.

JM: You want me to set you up for a procedure on Monday?

TS: Yeah, we can do a Podcast while I’m having it done. What do you think?

JM: I like that. I think your listeners would love to see that.

TS: I’m sure they would.

JM: Let’s make it happen.

TS: All right, I’ll be flying out tomorrow. Is this a private pay market, or do you have some sort of reimbursement strategy?

JM: No, this is a private pay. This is coming out of the patients’ pockets. But again, their glasses are coming out of their pockets, and their Lasik comes out of their pockets. There’s going to be some small component of insurance, but this is a private pay, and rightfully so. I don’t see this as a reimbursed procedure. The government is not going to be paying for this and I completely understand and agree. We are looking only for private pay. And that’s how it is across the globe, too. This isn’t any different here in the United States. Everywhere we sell this in over 50 countries, it’s private pay.

TS: We had a great discussion about private pay at OIS. Are you going to talk to your buddy Bill Link about this? Does this find its way into Alphaeon’s tool bag at all?

JM: No, no, no, you know, we are – which you did a great job, by the way, moderating. If this Podcast thing doesn’t work you, you’d be a great comedian. You’ve got a great sense of humor. I would say no. We are hiring a sales force. We’ve already hired a sales force. We’re going to go direct in the United States. I’ve brought the likes of Darrin Dickson and Patrick Jacques over from my days at AMO, and they had left AMO and gone some other places. But we are going direct. This is a great opportunity for us in the United States. And then I know we want to talk about the Inlay, but of course outside the United States, we have CE Mark on the IOL, which Nick Tarantino talked about at the OIS, and we just got approval for Australia. So this small aperture space we’re expanding not just in corneal implant, but outside the United States we now have an IOL.

TS: That’s terrific. In the – you mentioned the IOL. What is next for AcuFocus? It’s obviously ramping up for the commercial operations for this, but where are you now with the IOL? I know you have the CE Mark. You got that last year. Where are you with the FDA in regards to that?

JM: Oh, we’re years away from bringing this technology to the US. It’s going to take again the same diligent work that we did with the Inlay. I think we’ll be a little more accelerated path simply because we’ve learned about this technology. It’s in a different medium, cataract. IOLs are somewhat – are a standard. The Inlay is first of its kind, and that’s the thing that’s most impressive is usually first of a kind, it takes a while because after Dr. Edelman and her team approved it, it then went up to Bill Maisel, and that takes even a little more time simply because first of its kind should be treated that way. So the Inlay is first of its kind in the United States. Real excited. So where we’re taking it is we’re the small aperture company. We’ll be able to take that 45 plus all the way outside the United States, and in the United States we’ll take that 45 to 60-year-old and bring the Inlay.

TS: And is this something – in Europe this is being used in conjunction with Lasik, right? Is that something that’s done there and if it is, is that something that would be done here?

JM: We do not have approval for Lasik. Our Inlay is indicated for near vision by extending the depth of focus in presbyopic patients. I want to talk about that. We have an emmetropic refraction of +.5 diopters to -.75. In Europe, it’s a little different labeling with regard to Lasik. But there’s a large group of emmetropes out there that are very capable and very ready to have this procedure. Every practitioner we’ve talked to who is adopting this technology, and at the show we were able to really get a lot going, they’ve got a lot of these patients waiting. They were waiting for this technology. So it’s not going to be shy of patients walking in the door. There’s a lot of patients with this condition, with this labeling that we can attack. And I did want to add that depth of focus. You know, I think that was a key component of labeling, too. At the OIS you heard a lot about depth of focus, and the Inlay is getting the same approval. It’s by calling it extending the depth of focus in presbyopic patients, as we have in the intraocular lens. So the days when we created aspheric intraocular lenses at AMO, and then you had accommodative and multifocals, now the new category and where everybody is going is extended depth of focus. Because distance is critical. That’s the safety factor. But not everybody can provide near and intermediate. So we’re going all the way from near through to distance. So I’m really pleased with this labeling as well, and being able to attract the patients that we want.

TS: This is where I get the opportunity to ask stupid questions. How do you define extended depth of focus? What does that mean, really?

JM: You know, again, I will tell you that I believe that extended depth of focus, and you heard – I don’t know if you were at the breakfast – that Malvina and Jack Holiday are actually working on this as we speak, but to me it’s not compromising a near, intermediate or distance. Right now, most of our technologies compromise one of those three. And our goal is to not compromise that vision.

TS: Interesting. And just looking at the FDA approval, there’s a lot of language assigned to that who this good for, who this is not. And the question of or the issue of dry eye came up several times, warnings about not intended for patients who have cataract surgery or severe dry eye. It’s mentioned dry eye a few times. Does this really underscore the severity of the dry eye problem that seems to be getting more and more attention in ophthalmology? Is it just another indication of how pervasive dry eye is?

JM: Yeah, I think you’ve hit the nail on the head here. I believe that dry eye is actually – I would recommend that every procedure today, an intraocular lens procedure, a Lasik procedure, that a proactive approach to measure a person’s dry eye, we will get better outcomes. And I don’t think there’s a physician on the land that would disagree with me. I think dry eye is still an underscored, underappreciated problem that patients have. You know, the ocular environment is challenged today, both environmentally and physiologically. And I would, and I think you’re seeing a lot of physicians now, before I did any surgical procedure, I would see what type of a dry eye environment I’m dealing with, or an ocular environment, and then deal with the dry eye, and either prophylactically give an over the counter, or if it’s a critical nature, give a Restasis. You bring to that happy medium, and then you do the procedure. And I truly believe all outcomes, not just with the Inlay, all outcomes will be better. And Dr. Zaldivar, Roger Zaldivar from Argentina talks about this in his talks that we give on the Inlay, where he is using the AcuTarget HD to be able to measure that tear film. He manages that tear film, then does the Inlay, and his outcomes are far better because he managed the problem that’s consistent with all of us before he did a surgical procedure.

TS: Great. And going back to OIS, thank you for your kind words about the panel. That was a fun one to moderate, and we ran that on the Podcast last week. So Bill’s a good sport. You did a great job as well, as always, with our anchor panel at the end of the day, when will we have, in this case called them the Masters of the Universe up there. What was your take away from that panel? I was really struck by J. Michael Pearson’s offerings that, you know, basically suggesting that look for innovation; we’re looking – we’re going to do what we can inside, but we’re really looking to you folks in the audience to come up with the great ideas. What did you think of his discussion and what was your takeaway overall from OIS?

JM: Well, first off, I’ve done now, I think, the Masters of the Universe three of four times. And we’re going to continue to make this a mainstay. I think any time you can get those type of people on the OIS panel – in fact a plug for the Vegas one, Brett Saunders has already agreed, the CEO of the new Allergan – it really is worth its ticket right there because how many times can you get the leaders of all these companies as well as Bill, who is a leader really in the venture world, sitting on stage? So I first have to say it’s just great and I have a lot of fun with these guys. And we had some new ones. We had, as you said, Mike Pearson from Valeant, and I had Ludwin Monz from Zeiss. And last time I had – you know, we had representation – Ashley McEvoy from J&J. So we’re always adding to it with some consistency of Jeff George and Murthy. So to answer your question directly, I appreciated that Mike decided to come and to meet with the group. This was the first time I really had a face to face interaction with him. I think what it definitely shows is that companies are taking different approaches to our space. He did make a mention, I think, in his introductory remarks prior to the Master of the Universe panel that ophthalmology still holds a very significant presence in what they’re doing there because ophthalmology clearly has the unknowns. And you talked about dry eye, we talked about presbyopia, obviously glaucoma and ARMD. So I think he was just saying that his vehicle to be able to grow Valeant is through acquisitions, where you heard Jeff George and Murthy talk more of a compliment of both. I wasn’t surprised because we knew that, but I think it talks to the spirit of innovation, and all these – in this case it was all gentlemen – agreed that I don’t think you have to say it’s the – it has to come internally. I mean if you have a blend of the companies that do both internal and external, and you have one company who looks for external. My feeling on the OIS is I think they’re getting better and better. What I like about them, actually, I think the less presentations and the more discussions, because you get these off-the-cuff type of discussions. People think these are planned questions. They’re not, as you know. You led a panel. You don’t want to put anybody on the spot, but you gotta make sure that the seat isn’t too cool underneath. You put a little heat there. And so I would say that what’s turned for me OIS, and why it continues to be just a tremendous program, and it’s an all-day program, which is very rare to keep everybody in seats for all day, is you have sure enough some company new technology presentations, but you have these unbelievable panels: the one you led, the one I was privileged to lead. And I think then you get these individuals sitting in the room. And so again, I think that Emmett Gil, Bill, yourself, Craig have done a fantastic job. I’m pleased to be part of the committee that helps organize these. But it’s the highlight. And you ask anybody, they come early now just for OIS.

TS: Great. I’m really happy to be working with you on it, and I look forward to that panel in Vegas. It already sounds like a winner. Jim, thanks for taking the time. Congratulations on the news about Kamra again.

JM: Thank you very much. We’re really pleased. It’s very exciting to be in a first of its kind, and I appreciate the time, Tom, as always.

TS: Great. Take care.

TS: Thank you, Jim Mazzo for joining us a second time. Jim’s the third member of the OIS Podcast family to return following Bill Link and Emmett Cunningham, of course both co-chairs of OIS. So Jim, thanks again for taking part, and thank you all for listening. Tune in next week for our next tale of innovation. And as Jim suggested in the Podcast, he’s got something to look forward to with OIS at AAO in November. So keep your eyes peeled for information regarding that event.