Brian Pall, OD, MS, FAAO: Well, thanks for inviting me, Gretchyn.
Bailey: Recently, J&J had some good news to share regarding the approval of a drug-eluting contact lens in Japan. And it’s called Acuvue Theravision with Ketotifen. Did I say it correctly?
Dr. Pall: Yes that is correct.
Bailey: Tell me a bit about this goal. How did it come about and why was it first released in Japan?
Dr. Pall: Well, certainly. We always start with what the unmet need is, and we know in contact lens wearers that there is a significant percentage of people with eye allergies, resulting in itchy and rubbing eyes, which leads to eye irritation and eye rubbing. results in a lot of frustration and a reduced quality of life. So, knowing this and knowing some of the opportunities that exist with eye drops and the potential limitations of eye drops, the research and development team decided to look for ways to marry a contact lens with an anti-drug. -allergic and get potential benefits. contact lens wearers who experience itchy eyes.
I think the second part of your question was why Japan is launching in Japan. We know that allergy sufferers are found all over the world and experience the same symptoms and frustrations with itchy allergic eyes when wearing contact lenses. So we’re committed to developing the product and then getting regulatory approvals as we can. We were fortunate that Japan became the first country to give us regulatory approval.
Bailey: So when you say the first country, does that mean you have other countries with irons on fire for approval?
Dr. Pall: We are definitely committed to getting approvals in multiple countries. We work with regulatory authorities. As you probably know, the timing for all of this can be somewhat uncertain. But it is certain that we are proactively trying to get approval in several regions.
Bailey: Do you have an estimate of a deadline? Speaking of allergies, with a cat right there. Well done, it’s Jake. So yes, he has a cameo. We asked him to come and talk about allergies. Do you have an approximate timeline for the approval situation in the United States? Because it is a real area of interest for our viewers.
Dr. Pall: Certainly. So, again, the timing is uncertain at the moment. But we are actively in discussions and working with the FDA to make sure all the right requirements are met in order to get the necessary approvals.
Bailey: If we shift gears for a second, and talk about technology, because it’s brand new. Tell me how it happened and how it works. I mean, the patient can, do we put the lens on once a day, or what is the patient going to expect? I have a whole series of questions. So why don’t we start talking, and I’ll jump in.
Dr. Pall: It looks nice. Well listen, from a personal point of view, being able to work on something that is the first in the world is super exciting. We are talking about a lot of milestones in the contact lens industry. I am extremely proud to be involved in the world’s first drug-eluting contact lens. But what’s really interesting is how the science works and how we can not only incorporate the drug, but also allow the drug to come out and bring benefit to the patient.
The drug, as you mentioned, is ketotifen. It is packaged and incorporated into the contact lens, which is Etafilcon A material. It comes in a daily disposable modality. So when this product – ultimately, hopefully – hits the market, patients would wake up, put the lens in their eyes, and over the course of the day the drug would leak out of the lens, be absorbed. through the eye tissues. , then because they are exposed to different allergens or eye allergy triggers, this ketotifen, which is an antihistamine and mast cell stabilizer, can prevent the accumulation of inflammatory cells.
There is a triple action mechanism that occurs with ketotifen. Ketotifen has been well established all over the world for antiallergic treatments, and it has been shown to be very effective and safe. It is therefore a truly optimal marriage between an active ingredient and a contact lens material, which also has a long history of safety and performance.
Bailey: Well, let’s talk about this material for a second. So this is Etafilcon Acuvuematerial, but now it is going to be used as a daily disposable. And you said the patients would wake up with the lens. So, you mean apply the lens in the morning?
Dr. Pall: Let me repeat that. As a daily disposable product, the patient would wake up without a lens, then put the lens on in the morning. And then they were going all day. At the end of the day, the lens would be removed. This is typical in a daily disposable modality, similar to 1-Day Acuvue Moist, which is also made of Etafilcon A material.
Bailey: I get it. OK, so would patients be prescribed this lens at the same time as the other contact lenses they would wear? And then the patient would decide – and especially this time of year we’re talking about, early spring – that patients would wear that lens for a few days, a week, a month, whatever they decide, and then would go back to their contact lenses?
Best time to start
Dr. Pall: This is an excellent question. How it is ultimately delivered by the eye care professional will obviously depend a lot on the patients themselves. We know there are a lot of patients with seasonal allergies. So in the spring I am one of those who get itchy eyes with my non-medicated contact lenses. But there are also patients who have perennial allergies. So indoor allergens, such as Jake and his pet dander or other types of dust or mold can cause perennial allergies. So on a case-by-case basis, I think the eye care professional will likely meet the needs of each patient and better understand what is required for treatment. Then decide on the best combination of medicated and non-medicated contact lenses, if there is a combination, with instructions on when to use.
But I suspect the patient would derive the most benefit from stepping into the contact lens before allergy season. You don’t want this inflammatory cascade to kick in until you try it. It would probably be more effective to start with medicated contact lenses just before the season and then be able to experience that comfortable wearing of contact lenses throughout allergy season.
Bailey: Well, I was getting a little ahead of myself asking for prescribing recommendations for a product that is not yet approved here in the US. So, let me ask you the following question: what about patients who need astigmatic correction? Need a multifocal? Are we looking at line extensions for this purpose?
Dr. Pall: Again, one of the areas we are committed to addressing is the needs of all patients who could benefit from this product. Currently, approval for Japan is on a spherical lens. But certainly, in research and development, our job is to continue to innovate as much as possible to bring this technology to as many patients as possible.
Bailey: If we go back to technology, I know I’m jumping all over here. Can you tell me a bit about how it works? How does ketotifen get into the lens material? I guess it comes out slowly on the ocular surface. So talk a bit about how you introduce the medicine and then how the patient gets the medicine to get onto the eye surface.
Dr. Pall: There is an optimal marriage between the lens material and ketotifen. It is quite unique in that there is that attraction, or synergy, between the drug and the contact lens material which allows, during the manufacturing process, for the drug to be absorbed by the lens. And it stays in a state of equilibrium until the lens is then removed from the packaging and put on the eye.
Now our clinical data has shown that the impact and effectiveness of the drug can occur as early as 15 minutes after placing the lens on the eye. The duration of the action is at least 12 hours. We tested as early as 15 minutes and as long as 12 hours. The ability to get that rapid onset of action and that long duration of action is through this release of the drug that occurs relatively quickly and then more sustained over time.
We have presented some of this data at scientific meetings to show that there is a very consistent dissemination over time. Several hours after the drug has been released and absorbed into the eye, it is able to provide long-lasting action against itchy eyes.
Bailey: It’s really interesting. I am assuming that you are also considering other drugs for post-surgical drug eluting contact lenses. I mean, there is glaucoma and there are endless possibilities as to how it could help patients.
Dr. Pall: Agreed. I mean, breakthrough innovation in this field, there are so many opportunities. I mentioned that there are potential limitations with eye drops, so you think about the downsides if someone needs to dose eye drops throughout the day. The regularly reported non-compliance that patients have with eye drops.
The other advantage of administering drugs via a contact lens, particularly in a daily disposable modality, is that the lens already comes in a sterile individually packaged dose. Unlike many other eye drops that need a preservative to allow multiple dosages, a contact lens can already be sterile and a product not preserved. We think this is a real advantage, especially to return to the allergic therapeutic indication that an eye is already irritated or inflamed. Being able to deal with an unrecorded product may actually provide some benefits. From a high level theoretical point of view, we believe that there are many advantages of Acuvue Theravision in the treatment of diseases of the ocular surface.
Bailey: Well, this is all really exciting Dr. Pall. Thank you very much for taking the time to speak with me about J&J Vision’s revolutionary new lens, Theravision.
Dr. Pall: Gretchyn, thanks for inviting me here, and I really enjoyed talking to you.