Introducing ACUVUE TheraVision with Ketotifen

Introduction to Ocular Allergy Treatments

Treatment of allergies often involves removing contact lenses (if you wear them) and utilizing one of many options of eye medicines containing antihistamines and mast cell stabilizers to combat the symptoms of itchy, swollen, red, and watery eyes. Treatments have been fine-tuned to the typical use of these drugs by placing eye drops, either once or twice per day, into affected eyes. An alternative mode of treating ocular allergies with one of these medicines has recently been introduced. Johnson & Johnson Vision Care has recently gained FDA approval for the world’s first marketed drug-eluting contact lens on the market, the ACUVUE TheraVision with Ketotifen contact lens. It is currently being distributed in certain countries outside of the US, but is not being distributed in the US as of yet. It is expected to become available in the US in 2024 if production hopes are met.

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Evolution and Purpose of Contact Lenses

Throughout the years, the purpose of contact lenses, for the most part, has been to correct refractive error. Light is supposed to focus on our fovea, and when it doesn’t, we call that refractive error. Myopia (nearsightedness), hyperopia (farsightedness), and astigmatism are all forms of refractive error that soft contact lenses can correct. Rigid Gas Permeable lenses and scleral contact lenses correct refractive errors as well, but often employ a special optical design (due to certain corneal anomalies that may exist on a person) to achieve the same purpose of restoring focus onto the fovea. Learn more about types of contact styles.

Therapeutic Uses of Soft Lenses

Soft lenses also can be used therapeutically. The most common use of a soft contact lens therapeutically has been as a “bandage contact lens”. These are used when the cornea of the eye gets scratched or has an erosion, or is being irritated by the lids or lashes. In these instances, eye doctors tend to reach for a contact lens that will provide a protective cover (much like a Band-Aid covers a wound) so the cornea will heal or be protected.

Traditional Methods of Medication Delivery to the Eye

There have typically been two basic methods for getting medication to the eye when it is needed. We have the option of ingesting a medicine (pill or fluid) or eyedrops. The problem with oral medicines is that the drug must go into the gut, then into the bloodstream, and then, by way of the blood vessels, to all parts of the body (which includes the eye). As you can deduce, this “full body treatment” utilized in an attempt to treat an eye condition can potentially have unnecessary side effects throughout the body… an often inefficient method to treat the eye.

Advantages of Eye Drops and Drug-Eluting Contact Lenses

Eye Drops are a much better design, when compared to oral meds, to directly apply in the eye without the added risk of bodily side effects becoming involved. Only the eye receives the applied drops, and as long as the drug does not enter the circulatory system (this can be supported via “punctal occlusion” – blocking the channels at the nasal corner of the eye so the medicine does not drain into the nose). This targeting of the eye is effective, but it must supply a strong enough dose that it will last until the next drop is put in. This can be problematic because we may miss the eye, tears may wash it away, or it may blink away before an effective dose gets absorbed by the eye tissue.

This new design utilizes a medically dosed contact lens to target a more direct application of the drug to the eye and to greater limit transfer of the drug traveling to the rest of the body. A contact lens can do this by distributing a slower dose release (referred to as drug-eluting) for an even more direct and efficient form of medicine installation.

The FDA approval of the first drug-eluting contact lens for the US market occurred in March 2022 with ACUVUE’s TheraVision with Ketotifen. TheraVision is a one-day disposable contact lens that can correct refractive error and slowly release Ketotifen into the eye over a five hour period… sharpening vision and providing allergic symptom relief. Both the material and the drug have been on the market in various forms, and ACUVUE has found a way to combine them to create a first of its kind market, a medicated contact lens.

Lens Material and Design

The ACUVUE TheraVision lens is built with an “old style” hydrogel material that is made from the same building block as the ACUVUE Moist and ACUVUE Define brand lenses, etafilcon A. Etafilcon A has a very low oxygen transmission with a Dk/t value of 25.5. To put this value into perspective, a value 24 or below is considered to definitely cause swelling and other oxygen deprivation issues in the cornea with daytime wear. A 25.5 Dk/t value is about as close as you can get to this minimum Dk/t without “absolutely” causing swelling to the cornea. However, despite this low Dk/t number, the Moist lens has proved itself as a comfortable one-day disposable that was released in 2006 and is still used by many wearers today. Part of the reason for its success may be the lower price tag that it carries when compared to recent designs of more breathable silicone hydrogel one-day contact lenses, but it is also because, overall, they are a comfortable, low-problem lens. Though the etafilcon material has poor breathability, the oxygen transfer to the eye has been maximized in the Moist design with tear flow through, around, and under the contact lens during wear. Given that the Moist has demonstrated an efficient design with the etafilcon material, ACUVUE has utilized a similar design for efficient tear flow with the TheraVision lens as well. The TheraVision comes in one base curve (8.5), one diameter (14.2 mm), a class 2 UV-blocker, a power range of availability from +6.00D through -12.00D, and is only available in 30-packs (one month supply for one eye).

Understanding Ketotifen’s Role

Ketotifen is a drug that treats allergic reactions in the eye from two angles: it is both an antihistamine & a mast cell stabilizer. What does that mean? For example, if I am allergic to pollen, my immune system has identified pollen as a “danger” and creates antibodies for it. Pollen is then considered my “allergen”. These antibodies will then travel all around my body and attach to the membranes of mast cells. When the antibodies come in contact with pollen again, wherever they may be (such as mucus membranes of the eye or nose), it triggers the mast cells to release its contents immediately. Since mast cells are filled with histamines, histamines pour into the affected site and immediately cause blood vessels to dilate and leak. This means that the affected mucus tissue will become red and swollen. The extra occupied space will also create pain and stimulate nerve endings that will make the area itch. Hence, an antihistamine will block the effect that histamines have on an area, and a mast cell stabilizer will stop the mast cell from even releasing the histamines in the first place.

Ketotifen has been around for treating allergies in the eye since the early 2000’s. It has been distributed into the eye as an ophthalmic (eye) drop in the form of solution drugs named Zaditor, Alaway, Claritin Eye (now discontinued), Zyrtec Itchy Eye (now discontinued), and more recently Alaway Preservative Free. These eye drops are put into the eye twice a per day as an effective way to treat allergic eye reactions.

TheraVision’s Unique Approach

TheraVision has a preservative free design of Ketotifen distributed into the etafilcon material using a newly developed process that maintains the drug’s efficiency. But, instead of a quick dose that is placed in the eye twice per day like an eye drop, with a Theravision contact lens, the Ketotifen takes about five hours to be fully released from the lens. This slow release gives a much more directed effect on the eye with a lower chance of drug loss or side effects throughout the body. The anti-allergic effect lasts up to twelve hours, but the lens could be worn longer if desired. Only one lens should be used each day (you should not put another lens in the eye, even if symptoms return), and the lens should be disposed of after a single day’s use.

Proactive Use of TheraVision

Now let’s consider whether TheraVison is a “good thing”, or a “bad thing”. On the positive side, TheraVision provides a wonderful solution to distributing a known amount of drug directly into the eye for a more precise point of attack… into the eye, and not the rest of the body. It also provides optical correction with contact lenses that previously were recommended against wearing during peak allergy times. On the negative side, if the eye is already irritated and red from allergic conditions, wearing any contact lens (especially one that has low oxygen transmission) is contraindicated. In fact, in the package insert for TheraVision, it states, “This product should not be used to treat red eye(s). Remove the lenses immediately if the eye becomes red or irritated.” If we keep this “red and irritated” recommended restriction in mind, it guides us down the path of how to use TheraVision in a more effective manner than waiting until you have symptoms.

When you recognize that you have an allergy, an attempt should be made to identify the cause of your allergy… your allergen. Perhaps look at the calendar to identify the date that your allergies begin and identify the possible pollen that was in the air at the time. If the cause is not apparent, consider going to an allergist who can help you figure out your allergen with some directed tests. Once you identify the cause, hopefully, you can simply avoid your allergen altogether. Or, if you can at least identify the timeframe of your allergy, then perhaps you can treat your allergies prophylactically.

Consultation and Availability

Identification of the allergen or its time frame makes treatment with the TheraVision lens more practical and efficient. Perhaps TheraVision can then be used to stop an allergic response before symptoms even develop. For example, let’s say every May 10th your allergies begin and last until June 10th. Given that it takes about a week for a good mast cell stabilization response from the ketotifen and your desire to have an extra “margin of error” room, you could consider wearing the lens from May 1st until June 20th. Before and after this period, you could go back to wearing your “usual” contact lenses. If you are the kind of person who has eye allergies all of the time, then perhaps the TheraVision lens can be used more routinely. This is currently only a speculative therapeutic design, however, and the precise protocol has not yet been determined.

Before you determine that the Theralens is the lens for you, however, have a discussion with your eye doctor about your symptoms and concerns. Often, chronic conditions of the eye that many believe to be caused by allergies, end up being something completely different, such as dry eyes. Make sure that you see your eye doctor (not your general practitioner) about your eye problems, and if it is determined that allergies are the true source of your troubles, then go ahead and inquire if TheraVsion is right for you. Again, TheraVision is not available currently (article date: Oct 2023) in the United States, but it is expected in 2024, so your doctor may not yet be aware of this lens.

When TheraVision with Ketotifen does arrive in the states, it will be interesting to find out how it is distributed. Since it is the first of its kind (a drug-eluting contact lens), it is not clear how it will be dispensed (though it may be the same as every other contact lens). When it does become available, and if online sellers can distribute the TheraVision lens, make sure that you make your order from DeliverContacts.com for the best prices on the market from a doctor-owned company that promotes upstanding ocular health practices. Also, DeliverContacts.com offers always-low contact lens pricing with free delivery on all their contact lenses from ACUVUE (Johnson & Johnson), ALCON, BAUSCH & LOMB, and COOPERVISION.

Future of Medicated Contact Lenses

TheraVision is likely the first of many medicated contact lenses that will become available in the near future. Currently, for the TheraVision lens, the hydrogel (older style, less breathable) material is the only type of material that has been manipulated for absorbing and storing the ketotifen med for later marketable delivery to the eye. Other medicines each have their own properties, so each will have its own specified material (perhaps even a silicone hydrogel lens) that is most conducive for its use. However, the technology of contact lenses is constantly being improved, and so are the methods of incorporating medications into the lenses. And don’t think that treatment stops at allergies either, as meds of all sorts may eventually be marketable in contact lenses. Glaucoma medications and antibiotics have been tested already, but the capacity to market a lens that can hold the medicine without complications has proven difficult. Who knows? Perhaps the potential for treating even systemic conditions may also eventually be on the drawing board. Wherever this technology takes us, it’s definitely going to be a fascinating journey, and you can remember that it started right here, with ACUVUE’s TheraVision with Ketotifen contact lens.