Podcast: Talking about the anterior segment pipeline for 2023

Ehsan Sadri, MD, FACS, and William Trattler, MD, highlight some of the pending FDA approvals and PDUFA dates in the anterior segment sector and what these products will mean for ophthalmologists and their patients.

The views and perspectives expressed are those of Dr. Sadri and Dr. Trattler.

Editor's note: This transcript has been edited for clarity

Sheryl Stevenson: Hi, everyone. This is Sheryl Stevenson, group editorial director with Ophthalmology Times®. Welcome to this episode of our EyePod podcast series. As many in our audience are aware, there is a mega list of pending FDA approvals and PDUFA dates across ophthalmology in 2023. We'll take a look today for the purposes of this podcast segment on the anterior segment. Stay tuned for our retina-related podcast soon.

In this segment, we're joined today by two special guests from the West Coast to the East Coast, we have it covered. Dr. Ehsan Sadri is CEO of Visionary Eye Institute in Newport Beach, California, and Dr. William Trattler, who is director of cornea with the Center for Excellence in Eye Care in Miami, Florida, both who will provide an overview of some of the pending pipeline approvals and what these will mean for ophthalmologists and their patients. Dr. Sadri, take it away.

Ehsan Sadri, MD: Thank you, Sheryl, for putting this together for us. As you know, we get together once a quarter with Bill (Dr. Trattler), who's a good friend of mine and go over the pipeline, what's coming down the pike, and what's exciting for us. We have a nice long list that we're sorting through. There's a lot of stuff to talk about in retina. What we decided is to have a retina colleague join us to talk about those approvals. I think that'd be appropriate. To Bill's point, we don't want to talk about premium IOLs for a retina doctor, which is great, and vice versa. They probably don't want to hear me talk about GA [geographic atrophy] or treatments, but we can have them on and so be on the lookout for that podcast. I'm just really happy to get you, Bill. How have you been? The family is great?

William Trattler, MD: Thank you. Everyone's great. Excited to be here with you, Ehsan, as always, and just lots to look forward to. Our practice is ever-changing and new technologies. That's why I love these conversations with you because we get to talk about what's in the pipeline, what's about to come out, and how our patients will benefit.

Sadri: Absolutely. You and I see patients every day, all walks of life, all different types of payer mixes. You and I both are so excited about the unmet need, and what's coming down. We have this amazing pipeline, but then it's kind of slow to get approved and get covered so we'll talk about that another time. Obviously, for the scope of today, we're going to be talking about what's coming down [the pipeline].

Let's start with dry eye. You're an expert; you've written many papers; you're a thought leader in this space. What excites you in the next 6 to 12 months that you think are going to get PDUFA for our patients?

Trattler: Well, I think that right now we have a lot of very good treatments for dry eye. Obviously, we still see patients every day and there's always patients that need more help. There's technology...we just need more technologies, more treatments. Thankfully, we have therapies, we have procedures, but they do cost or aren't covered by insurance; we have medications that may or may not be covered by insurance. Any new technologies we get to help our patients is definitely exciting.

I guess number one on the list for me is Tarsus, because that technology looks very promising. It's surprising how common blepharitis is in our patients. When you actually have patients look down...this is new for me, when I started having patients look down and look at their eyelashes, scurf is actually present in about 50% or more patients from all different age groups. So just very common. It's just a sign that these patients have excess bacteria on their eyelashes, as leading to issues with their meibomian glands. Having treatments for a healing aspect is the underlying part of scurf and blepharitis is just going to be so helpful for patients.

Sadri: Absolutely. You touched upon a couple of really good points. It's probably a pivoting new medication...paradigm shift in our practices. We haven't had to honestly have patients look down like you were saying. I think that's kind of new for us, but also the novel treatment of lotilaner, or TP-03, for the treatment of Demodex blepharitis. To your point, there's a lot of unmet need. This is one of those disease states where I think it's going to lead to a lot of patients that are going to do a lot better from an anterior segment standpoint. They're on artificial tears. Maybe they've been on a cyclosporine.

They haven't gotten a relief. This is gonna be a game changer for a lot of patients. That's a great one to start with. There's going to be great opportunity, some challenges also, but they have a great team. I think the PDUFA for that is August 25. More to come obviously from FDA. I think we're going to be super excited.

Let's pivot now. What do you think about the role of Bausch and Lomb [B&L] and Novaliq. As you know, they've got the new PDUFA associated with treatment of meibomian gland, and that's going to be June 28, 2023. What are your thoughts on that?

Trattler: I am super excited. This product makes so much sense. When I first heard about a water-free solution...water-free therapy for dry eye, it's like a lubricant and it makes sense. Like in your car engine, you don't have water to keep it lubricated, you actually use oil. This is a type of lubricant that's going to make the eye feel more comfortable, and help especially when there's patients that have a lack of meibomian gland secretions, they don't have enough oil layer, their tear film is insufficient to maintain the aqueous portion of their tears. This is going to be a perfect product to help these patients. I think it's going to be used in all varieties of dry but obviously, it's key towards a patient that have lipid deficiency or not enough oil in their tear film.

Sadri: Yeah, you nailed it. I think this is an unmet need, which you and I get excited about. It's gonna be evaporative, right. So it's going to hopefully get good coverage because it's different from the previous anti-inflammatory so can't be pigeonholed in those areas. That's something that really... I don't want to use the word 'frustrates' but it's frustrating for us just because we get excited about PDUFA, all this R&D, we do clinical trials together, and then it kind of goes to this buzzsaw when it comes to insurances.

I'm excited about new categories, because I think it forces the payers to look at this stuff in a different fashion and really forced to have the coverage for our patients. Okay, so with that said, cyclosporine is a molecule that's been around a long time.

Novaliq has another product. June 8 is coming up. That's the PDUFA. What are your thoughts on that segment and what they're doing?

Trattler: Well, I'm excited again. I don't know as much about this product. But it seems very promising. Cyclosporine is a very effective therapy for dry eye and the fact that we might have a combination product that's going to really help our patients with dry eye get more effective cyclosporine therapy that makes a lot of sense, to me.

Sadri: Yeah. Novaliq, as you know, they sort of did a smart job working on not only evaporative, but also anti-inflammatory components. So just to kind of try to own the market, and they did a really good job. It'll be interested in seeing now that Brent Saunders is going to be at B&L to see how they do this launch. Are they going to keep acquiring stuff. I hope so because I think that'd be good. We do need another strategic in the marketplace. So more to come on Novaliq.

We've left all the AMD, even DME, that's going to be in the pipeline for back with the eye [for an upcoming podcast]. Let's talk about the other one on our list today, which is basically Aldeyra Therapeutics. Do you know much about this? I noticed later on [their] PDUFA is in November. They've been in the news lately. They've got a couple of therapeutics, one is ADX-2191 for vitreoretinal lymphoma that's going to be in the back of the eye. For the front of the eye, they've got this reproxalap product for dry eye. It's coming up November 23. What are your thoughts on that? Have you heard much? I haven't heard much.

Trattler: What I understand is that this is going to be a really like a kind of a new class of anti-inflammatory that's gonna be working at a different level, kind of similar to steroids, but at a different level than steroids...working a little higher up in the pathway so that it's really going to impact your dry patients. I know that for me, my go-to therapy for dry eye is topical steroids. I use them all day, every day, whether it's MGD or aqueous deficient-dry eye combination. Topical steroids suppress inflammation, output tear production help with so much. It makes me just feel more comfortable. And apparently Aldeyra's product is going to work well for these patients with dry eye, and I'm not sure if it's necessarily aqueous deficiency versus MGD, or the combination, but having an anti-inflammatory that hopefully doesn't raise eye pressure and can be used throughout the levels of dry eye can be quite helpful for our patients.

Sadri: I agree. I mean, it's gonna be exciting. Anytime there's a new MOA [mechanism of action]. I saw their data. It's pretty impressive. I think at some point I interviewed their CEO, but I haven't heard much. So it's good to hear your perspective on it and I do think you're right. Whenever we have new player with a new MOA it probably will get, hopefully, a new ability to get coverage with our patients. Again, that's going to be a biggest sort of challenge for these companies.

The other two companies that I think you and I should talk about is interesting. Both of them get a lot of press right now. One is in presbyopia.

The other one is an in-the-office ophthalmic solution for reversal of mydriasis. So that's Ocuphire with their patented ophthalmic phentolamine solution. September 28 is the PDUFA. A lot of coverage on this product and company. I've seen them at Eyecelerator. I'm sure you've seen them in all your other meetings. What are your thoughts? How's this going to be used? What's their model? Is it going to be cash pay, or is going to be covered? What do you see in your clinic happening with this?

Trattler: I think that is going to be purchased by practices and sold to patients as a way to quickly speed up their patients' pupil size so that after they're dilated, they can take the drop and get back to their normal pupil size much more rapidly. It's funny that I still have patients asking me even 15 years after the old version was available, 'hey, do you still have that product?' and hopefully, we don't. This is going to be something that's going to be well liked by patients. Again, we'll see what the economics are in practice, how do you figure this out. That still needs to be figured out but I do think that they really want it to be successful. I think they'll find the right price point to make it work for everybody.

Sadri: Yeah, it's funny, you say that, because I remember when I was training, we used to have reversibles. That was really popular, and then just kind of died. That whole thing. I'm really excited. To your point is, it's still being asked. There's a lot of patients that go [to eye appointments] between work. I had one today who works with a big finance company and he's like, 'I can't go back to work' and it's morning time he came by. That's a classic example, and he would have paid for it.

I think the economics, how it's done, all that stuff. I think they're doing all the right things when it comes to talking to the KOLs and trying to price it right. It's going to be interesting, but I do think it's exciting. It's cool.

The other one is Orasis, which is 0.4% pilocarpine for presbyopia. Their PDUFA is October 22, 2023. Coming up. So probably if that goes through, they'll be the second after Vuity. You and I've talked about Vuity and the presbyopic pharmacological treatment of presbyopia. What are your thoughts there as a category, this one and the other ones you're excited about? and what should they do differently? You feel like, if they do launch, it sounds like they're going to probably launch and pull commercial, what do they need to do in order to get more traction?

Trattler: First of all, I think the whole class and the concept of presbyopia drops to me, it makes so much sense, and it works for me. Like when I use Vuity, I can see without glasses for a certain number of hours a day. I'm excited to experience Orasis' to compare the two and see how they work. For me, and for my patients, it's going to be exciting. The more options we have, and maybe for certain patients one version works best. Maybe Vuity is best for a certain group of patients; maybe Orasis is better for different group of patients. Obviously and so many others coming out from Visus and LENZ, I don't want to forget them all. Ocuphire is having theirs. We have a lot of great products coming out, and as we get more experienced we'll figure out which works best for which patients.

This category is important, especially for patients that have had previous LASIK and had great vision for 20 years without glasses. Now they're in their mid-40s and they don't want to wear glasses anymore. They see great for distance. You could try to redo one of their eyes and get better for reading, but you don't have great choices for them. I'm going to say that this is a great category and is great for our patients.

Sadri: I couldn't agree with you more. I think that AbbVie/Allergan did a great job of educating the market. They did a lot of direct to consumer. They probably learned a lot of lessons along the way. I think as a sector, as a whole, sort of unmet need...130 million Americans. Big market. I do think you and I probably see less and less of these people. Mostly of the optometrists see them.

But you're spot on. You've got these LASIK patients. You're not going to do RLE [refractive lens exchange] on a plano eye, and there's nothing else so what do you do. You're sort of left with the option of drops and I do think that's a huge market. Also, patients that are still in their 40s, 50s, sometimes 60s, they come... I don't know how they do this. They're seeing 20/20 plano at 60 years old. They don't want any surgery, and they don't like readers. They may or may not be to your point of concentration and class and MOA whether or not they're going to try. I definitely think from a risk tolerance/cost analysis, it is a no-brainer. I'd love for this category to take off to be honest with you. I know it won't benefit us necessarily because we're doing surgery, but I do think it'll benefit our patients. I think there'll be a definite room for it. I'm so glad to hear you've always been supportive. I've seen your LinkedIn comments. I'm very supportive and I definitely think that some patients do better with higher concentration of pilo [pilocarpine] than others. I use this product; I use Vuity pretty much 2 or 3 times a week myself still. I do think it's a learning curve for us and ODs on how to sort of troubleshoot the patients. I'm looking forward to multiple horses in this race to clean that up and make it really just blow up.

Trattler: Yes. I totally agree. I'm super excited. It's great to know that I guess company is going to have their product in 2023 and hopefully, some of the other companies will come out shortly thereafter. More choices for patients, more buzz from more doctors...trying to sit on the sidelines. Eventually, you can't because patients are going to be asking for it because this fills this zone that patients that aren't the best candidate for surgery, and drops won't solve the problem and avoid glasses and contact lenses. It's a pretty exciting area for me.

Sadri: Yeah. I would go back and I would say because it's such a big market, we need to almost put together a consortium, almost like we did for cornea, like what we did for glaucoma. I think there's a missing gap there, where there's leadership of the KOLs and thought leaders that can field questions and how to market to patients. I honestly think it's so big, that what we should all do is work together with all the companies to work together. When you go to Orbitz and buy a ticket, Orbitz is owned by all the airlines. Most people don't know that it's owned by Delta, United, American, etc. They all pitched in and launched this app and everyone buys it, and they did a revenue share.

I think they almost need to do that. Because to your point earlier, there's so many companies, and you don't want to have them infight. You want to have them blow up the whole market and educate the doctors, and doctors decide. I think that will be exciting, as opposed to sort of, 'oh, this one causes this' and 'the other one doesn't work,' etc. Yeah, I think that won't do anything good for anybody and I don't know what your thoughts are on that. I firmly believe that for us to have the conversation first with our KOL colleagues and in addition to the comprehensiveness and then in addition to that our optometrists that are actually seeing these patients and give them guidelines on the dos and don'ts and our support will help maintain the growth of this sector.

Trattler: I 100% agree. This is going to be...these are all great ideas. Once you get more of the companies launched, then we'll see how things play out. But being positive, because in general, these are positive medications and helpful for patients. The key is to just to figure out how to help each individual patient in the best way possible.

Stevenson: Thanks to Dr. Sadri and Dr. Trattler for participating in today's podcast segment. Audience members may listen to this and other podcasts at OphthalmologyTimes.com/podcasts.

Thank you.