Managing Ocular Allergy Patients in a High-volume Practice

In fast-paced practices, there's no time for trial-and-error. Here are some proven strategies for keeping ocular allergy patients comfortable and symptom free.

If you feel you've seen more than your fair share of itching, tearing, watery, swollen, red eyes and patients complaining of burning, stinging, foreign body sensation and contact lens intolerance, you're not alone. We interviewed clinicians from various regions of the country, and they confirmed they were experiencing the worst allergy season in recent memory. In many areas, an unusually wet winter triggered an exceptionally verdant growing season, which resulted in higher than normal pollen counts. In this article, we reveal how these busy ophthalmologists manage patients suffering from itching associated with ocular allergies year round, but particularly during peak allergy season.

Busy practices made busier

April 15, 2010, was a taxing day for people in the Kansas City area, and the stress was not entirely related to the IRS. "The pollen count on that day was 5000 ppm," says Melissa Cable, MD, a general ophthalmologist and partner in Discover Vision Centers. "To put that in perspective, people with asthma and allergies start having problems at 15 ppm, and they have mechanical issues from pollen at 50 ppm. So when we reached 5000 ppm, we were seeing patients left and right, newly diagnosed and previously diagnosed, who were having terrible exacerbations."

The situation was similar in Florida this spring, according to Barry Schechter, MD, director of cornea and external disease at Florida Eye Microsurgical Institute, Inc., in Boynton Beach. "This has been one of the worst allergy seasons we've had in about 15 years," Dr. Schechter says. "Typically, about 20% of our patients have some type of ocular allergy symptoms, but this spring, it was closer to 50%."

According to Trung Nguyen, MD, poor air quality in Southern California often combines with a high pollen count to increase the number of allergy patients at Advanced Eye Care Clinic in Orange County. And the allergy story is similar in New York City, says Raymond Fong, MD, who notes that even in the city, air pollution and pollen will trigger or exacerbate patients' symptoms.

Presentation and diagnosis

These physicians tackle ocular allergies head on, and the diagnosis is usually swift. "A lot of people know they have allergies, and they know when they're having a seasonal exacerbation," Dr. Cable says. "This year, however, I saw many people who had never had allergy problems before, and we were breaking the news to them."

The hallmark symptom of ocular allergy is itching, but Dr. Schechter notes, sometimes patients talk about having a feeling of swelling around their eyes, or they say they're unable to wear their contact lenses. "They may have visual acuity disturbances, as well, if their eyes are tearing," he says, "but itching is the symptom that we most associate with ocular allergy."

A thorough patient history and differential diagnosis to rule out any infectious or noninfectious conditions that produce red, itchy, tearing eyes generally lead to a definitive diagnosis. "Patients may have infectious conjunctivitis or subclinical iritis, both of which cause red eyes, but when you combine patients' symptoms and history with the ocular examination, the diagnosis is usually clear."

Dr. Fong agrees that the diagnosis is usually straightforward. "When patients come in with classic symptoms — itchy, burny, red eyes — most of the time, it's allergic conjunctivitis," he says. "You don't have to figure out if it's allergy type 1 or allergy type 2. It's an allergy. Just treat it."

Therapeutic mainstay

As with any allergy, a physician's first recommendation is to avoid the allergen. With ocular allergies, as compared to food or skin allergies, this may be easier said than done. Some of the ophthalmologists we interviewed recommend that patients initially use artificial tears or an eye wash to dilute and flush allergens, and cold compresses to help reduce swelling. If symptoms persist, physicians consider ocular antihistamines. In severe cases, some may prescribe a short course of mild topical steroids. (See "Managing Severe Ocular Itching" below).

"The key is prescribing a therapy that will help relieve patients' symptoms immediately," Dr. Cable says. "You don't want to start them on a treatment and have them come back because it's not working for them. When you have that many people coming through your office, you can't afford to do trial-and-error to figure out what works for them."

As Dr. Fong notes, "I prefer to be treating cataracts and glaucoma and performing LASIK surgery. I don't want my waiting room filled with unhappy ocular allergy patients."

For rapid and sustained relief of ocular itch associated with seasonal and perennial allergies, the therapeutic mainstay is a topical ophthalmic antihistamine. The agent of choice for these physicians is BEPREVE® (bepotastine besilate ophthalmic solution 1.5%, ISTA Pharmaceuticals, Inc.). Why do they choose BEPREVE? Simply put, Dr. Nguyen says, "It works well, even against severe ocular itch."

Proven efficacy and safety

BEPREVE is indicated for the treatment of itching associated with the signs and symptoms of allergic conjunctivitis.¹ It's an effective mast-cell stabilizer, and it has high H1 receptor specificity² with low affinity for other receptors (particularly muscarinic) associated with dry eye, dry mouth and drowsiness.

"The fact that BEPREVE doesn't exacerbate dry eye is an important benefit for many allergy patients," Dr. Cable says. "These patients are off and on systemic antihistamines or other medicines that can dry their eyes and make allergy and inflammation worse."

Dry eye is also a concern for Dr. Schechter, who often sees concomitant dry eye and allergy in his patient population. "I try to keep people off of oral antihistamines if I can, because these drugs have a drying effect on the ocular surface," he says. "When you're dealing with dry eye plus allergy, the condition becomes more complicated and can damage the ocular surface."

Dr. Cable also notes, "BEPREVE is a comfortable drop, which is particularly important for patients who have chronic symptoms. About 40% of patients in the Kansas City area have allergy symptoms for more than 3 months a year, and 20% have symptoms for more than 9 months a year. These people must use their allergy medicines chronically."

The tolerability profile of BEPREVE has been demonstrated in clinical trials. In a 6-week safety study, eye irritation was not statistically significant compared to placebo (4.7% vs. 2.4%, respectively), and BEPREVE was associated with less dry eye than placebo (1.0% vs. 1.7%, respectively).³ In addition, none of the patients in the two efficacy studies reported dry eyes.4 Overall, BEPREVE demonstrated comfort equal to placebo in these studies.

The most commonly reported adverse reaction in clinical trials was a mild taste following instillation in 25% of subjects. The physicians we interviewed stated this effect is manageable for the subset of patients who notice it. For example, Dr. Schechter says, "A few of my patients have mentioned the taste. I teach those patients how to do punctal occlusion, and that usually solves the problem. These patients still find the medication very effective." No one in the clinical trial discontinued the drug because of the taste.⁴ Other adverse reactions reported in 2% to 5% of patients in clinical trials included eye irritation, headache and nasopharyngitis.

Although BEPREVE was recently introduced in the United States, bepotastine has an extensive systemic safety record, with more than 850 million oral doses given in Japan since 2000 with no drug-related serious adverse events reported.^5,6

Fast-acting and durable itch relief

Patients, too, want an allergy drop that works, and typically their expectations are high. "Patients want something that works immediately and gives them significant relief," Dr. Cable says. "Patients who are newly diagnosed haven't always tried remedies at home and may not know what direction to take, but many patients who've been previously diagnosed may have tried some of the products on the grocery store shelves and gotten incomplete relief. Now, they're looking for something else."

BEPREVE demonstrated rapid onset of action in the trials, with 95% of patients achieving clinically significant relief of ocular itch within 3-7 minutes after instillation of a single drop.⁷ This response was also durable, lasting at least 8 hours in 90% of eyes treated with BEPREVE.⁷ Furthermore, BEPREVE was rapidly effective against severe itch in these studies, with 68% of patients reporting complete relief (0 itch) of their severe symptoms at 3 minutes compared to only 3% of patients using placebo drops (Figure 1).⁸

"BEPREVE has helped many of my patients," Dr. Schechter says. "It doesn't waste time. It acts quickly and, based on my experience with treating unhappy ocular allergy patients over many years, is very effective. Most of the patients who try BEPREVE in the office go on to fill the prescription I write because they're so impressed with the medication."

Patients' perceptions of value

Efficacy and comfort spell value to patients, according to these physicians, but cost also plays a role, and all three factors influence compliance. "Efficacy is foremost," Dr. Cable says. "If a drop doesn't work for patients, they won't use it. If it's not comfortable, they won't use it. Price can be an issue, too. If it's expensive, they won't buy it."

BEPREVE is approximately half the cost of the leading prescription ocular allergy medications. It is indicated for b.i.d. dosing and is dispensed in a 10 mL bottle. When used as directed, one bottle provides 60 days of therapy for one copay.

"I like the fact that BEPREVE comes in a 10 mL bottle," Dr. Nguyen says. "Some of my patients complain that other topical prescription antihistamines cost too much, and there's never enough in the bottle. Unfortunately, some patients use a once-a-day drop twice a day, and they run out of their medicine before they should."

Dr. Fong has heard similar complaints. "Patients say, ‘Doc, these bottles are so small and so expensive. Can't you do something?’ When you prescribe a drop that comes in a single bottle and is a 2-month supply, patients thank you. They really appreciate it."

Another concern for Dr. Fong is determining what drugs are covered by a patient's insurance. He and his staff have painstakingly compiled a list of insurance plans and their formulary drugs. "You want to give your patients something that works and is cost effective," he says. "To me, costeffectiveness means answering the question, ‘Is it covered or not covered?’" He notes that ISTA Pharmaceuticals, Inc., provides a service (ISTA PAL through Apricot Medical Services) in which practices can enroll to obtain prior authorization for BEPREVE. "ISTA has really taken the lead in this," Dr. Fong says. "This program helps eliminate some of the paperwork and headaches associated with prescribing a new product. By using this service, I avoid receiving a call from the pharmacy to tell me the drug isn't covered. It has been helpful in my office. It streamlines the process."

One key to a successful practice, Dr. Fong continues, is to become attuned to your patients. "Often patients will say, ‘Yes, I want something effective, but I don't want something that's going to empty my pocketbook.’ When we combine ISTA's PAL program with our list of formularies, we prescribe a drug that's covered. This is a tremendous value to patients. In addition, when they receive that large bottle of BEPREVE with one copay, they say, ‘You know, Dr. Fong is really looking out for me.’ It makes my patients happy, and they refer more patients to me."

As important as costs are to patients, Dr. Nguyen notes that when patients are happy with a medicine, they may be willing to pay outof- pocket for it. "Patients tell me BEPREVE has a very good effect, and it's comfortable," he says. "It's a recently introduced drug, however, and it may not be on every formulary. Even when patients have to pay cash for it, they do so because it relieves their symptoms so well."

New era of relief

As experienced clinicians, the ophthalmologists we interviewed aren't easily swayed by new drug claims. As Dr. Nguyen notes, "All the drug companies say their drugs work well. I have severe allergies, so I try all of the drops before I give them to my patients. In real life, I find BEPREVE works for me, and my patients like it. BEPREVE is comfortable and well tolerated. It doesn't dry the ocular surface, and it's cost effective, which is important in this health care environment."

Dr. Cable notes, "BEPREVE is my topical antihistamine of choice to treat ocular itch associated with allergic conjuncitivitis, primarily because it's so specific in its actions, and it doesn't appear to exacerbate dry eye in practice. So many patients already have surface disease or concomitant dry eye, so this is an important consideration."

References

1. BEPREVE. ISTA Pharmaceuticals®, Inc. Package Insert.
2. Kato M, Nishida A, Aga Y, et al. Pharmacokinetic and pharmacodynamic evaluation of central effect of the novel antiallergic agent bepotastine besilate. Arzneimittelforschung. 1997;47:1116-1124.
3. Data on file. CL-SAF-0405071-R. ISTA Pharmaceuticals®, Inc.
4. Data on file. NDA 22-288. ISTA Pharmaceuticals®, Inc.
5. Baba S. Post-marketing surveillance study of Talion tablets on pediatric allergic rhinitis [in Japanese]. Rinsho Igaku. 2002;18:1371-1387.
6. Data on file. Osaka, Japan: Tanabe Seiyaku Co; June 2009. ISTA Pharmaceuticals®, Inc.
7. Data on file. CL-EFF-0910091-R. ISTA Pharmaceuticals®, Inc.
8. Clark JC, Williams JI, Gow JA, Abelson MB, McNamara TR, for the Bepotastine Besilate Ophthalmic Solutions Clinical Study Group. Bepotastine besilate ophthalmic solution 1.5% rapidly eliminates ocular itching in more severely allergic subjects in the conjunctival allergen challenge model of allergic conjunctivitis. Poster presented at the 24th Annual Eastern Allergy Conference; May 6-9, 2010; Palm Beach, Fla.