Can Allergy Drops Improve Nasal Symptoms?
Dual-action medications and combination regimens can make life easier for patients.
BY OPHTHALMOLOGY MANAGEMENT STAFF
For allergy patients, April is indeed the cruelest month. Expect to see your appointment book start to fill up over the next several weeks with visits from people who dread rather than welcome this time of year. Is there anything ophthalmologists can tell them that might lift their spirits? Yes, actually. Some drops for ocular allergy relief provide an added benefit: efficacy against nasal symptoms. Though likely not as robust as that from a nasal spray, any extra bit of relief is always welcome.
In its phase 3 clinical trials of the ocular allergy treatment bepotastine 1.5% (Bepreve), Ista Pharmaceuticals also assessed the medication's effects on nasal allergy symptoms. In two seven-week, masked, randomized, placebo-control led studies (n=157), the conjunctival allergen challenge (CAC) model of allergic conjunctivitis was used to evaluate patients' total non-ocular composite symptom score (TNSS) as a secondary endpoint. TNSS was defined as the sum of nasal congestion, rhinorrhea, nasal pruritis and ear and/or palate itching.
“It's important to study any drug's effects on all body systems,” explains Gregg J. Berdy M., an ophthalmologist in St. Louis. “Also, Ista knew bepotastine is a potent molecule that would likely have an impact on both ocular and nasal symptoms. Millions of prescriptions have been written for the oral form in Japan (Talion, Tanabe Seiyaku Co., Ltd.), which for several years has been approved to treat allergic rhinitis and itching associated with certain skin conditions.”
Ophthalmology Management asked Dr. Berdy and other physicians how the new information about bepotastine and other agents fits with the current thinking about treating patients with seasonal and perennial allergy symptoms.
A Concept Worth Exploring
The nasal effects of prescription ocular allergy medications in the same class as bepotastine — antihistamine/mast-cell stabilizers — have also been studied. (See “Ocular Antihistamine/Mast-Cell Stabilizers and Nasal Symptoms.”) According to Peter D'Arienzo, MD, an ophthalmologist in Manhasset, NY, “all of these drops will have some nasal effect due to their antihistaminic activity. We know allergic rhinitis goes hand in hand with eye allergy problems.1-3 So if an allergy drop can get into the nasolacrimal system and reduce nasal symptoms, it may allow for less use of nasal medications.”
Warner Carr, MD, an allergist in Mission Viejo, Calif., agrees that reducing the number of medications patients need to take, whenever possible, is a desirable goal. “Socio-economic issues are also important in today's world,” he says. “We should be conscious of the cost of multiple prescriptions and the time it takes for patients when they have to see multiple doctors.”
Additional Evidence to Consider
Based on the currently available research about the nasal effects of ocular allergy medications, Michael S. Blaiss, MD, an allergist in Memphis, cautions doctors not to expect a “magic bullet” for effective relief of both eye and nose symptoms. In his opinion, “there are better data showing that steroid nasal sprays positively impact ocular symptoms.”4,5 One such spray, fluticasone furoate (Veramyst, Glaxo-SmithKline), is FDA approved to treat the nasal symptoms of seasonal allergy as well as red, itchy and watery eyes.
Even so, Dr. Blaiss says, when treating patients with ocular and nasal allergy symptoms, several factors need to be taken into account. These include convenience/compliance issues, patient preferences and, most importantly, severity of symptoms. “Some patients will need specific treatment for both their eyes and nose,” he explains.
Judging by both the published research and his clinical experience, Dr. D'Arienzo finds site-specific therapy is often the most effective for ocular allergy relief. “Nasal sprays decrease nasal congestion, so perhaps that also improves tear flow and the washing away of allergic mediators,” he says. “But there is no physical way a nasal spray can get to the surface of the eye to help ocular symptoms. Allergy patients come to see us because their eyes itch. For that, they need an antihistamine on the eye.”
Furthermore, Dr. D'Arienzo continues, it is well-established that the oral antihistamines often prescribed to allergy patients by their primary care doctors tend to dry the eyes, which only serves to exacerbate ocular symptoms. “Unless patients have asthma or another condition that requires oral medication, I'd much rather have them use an eye drop for their eyes and a nasal spray for their nose if they need it.”
Dr. D'Arienzo participated in a study that supports the site-specific treatment approach. In the study, concomitant use of the intranasal steroid spray fluticasone propionate (Flonase, GlaxoSmithKline) and the eye drop olopatadine (Pataday, Alcon Laboratories, Inc.) was more effective than concomitant use of fluticasone and oral fexofenadine (Allegra, Sanofi-Aventis) for overall treatment of the signs and symptoms of allergic rhinoconjunctivitis.6
Several other studies of nasal symptom reduction have reached similar conclusions. For example, in a study by Spangler et al.7 comparing olopatadine 0.1% (Patanol, Alcon Laboratories, Inc.), intranasal mometasone fumarate (Nasonex, Schering-Plough) and oral fexofenadine, both topical medications provided more relief to the targeted tissues than the oral medication. Also, in a study by Rosenwasser et al., olopatadine 0.2% (Pataday) was shown to be “statistically and clinically superior to fluticasone nasal spray (Veramyst) for the relief of signs and symptoms of allergic conjunctivitis.”8
Patients Need Eye and Nose Relief
Taking the relevant research into account, Dr. Berdy says “there is likely a role” for the newest antihistamine/mast-cell stabilizing eye drop, bepotastine, in providing nasal symptom relief “but we don't yet know how it will play out.” Greater clinical experience and confirming studies will further elucidate how effective it will be for controlling symptoms beyond the ocular.
The take-home message for ophthalmologists, according to Dr. Berdy, is that “the dual-action eye drops are our armamentarium workhorses.” From a safety and efficacy standpoint, he says, they should be the first line of treatment for patients' ocular symptoms. “For those who also present with nasal symptoms, a drop may help. If not, we can also prescribe a nasal treatment or refer to an allergist for further evaluation.” OM
References
- Nathan RA, Meltzer EO, Seiner JC, Storms W. Prevalence of allergic rhinitis in the United States. J Allergy Clin Immunol 1997;99(6):S808-S814.
- Kosrirukvongs P, Visitsunthorn N, Vichyanond P, Bunnag C. Allergic conjunctivitis. Asian Pac J Allergy Immunol 2001:19(4):237-44.
- Schulman, Ronca and Bucuvalas, Inc. (SRBI). Allergies in America: A Landmark Survey of Nasal Allergy Sufferers. Available at www.myallergiesinamerica.com. Accessed Jan. 5, 2010.
- Blaiss MS. Evolving paradigm in the management of allergic rhinitis-associated ocular symptoms: role of intranasal corticosteroids. Curr Med Res Opin 2008; 24(3):821-836.
- Origlieri C, Bielory L. Intranasal corticosteroids: do they improve ocular allergy? Curr Allergy Asthma Rep 2009;9(4):304-10.
- Lanier BQ, Abelson MB, Berger WE, et al. Comparison of the efficacy of combined fluticasone propionate and olopatadine versus combined fluticasone propionate and fexofenadine for the treatment of allergic rhinoconjunctivitis induced by conjunctival allergen challenge. Clin Ther 2002;24(7):1161-74.
- Spangler DL, Abelson MB, Ober A, Gomes PJ. Randomized, double-masked cmparison of olopatadine ophthalmic solution, mometasone furoate monohydrate nasal spray, and fexofenadine hydrochloride tablets using the conjunctival and nasal allergen challenge models. Clin Ther 2003;25:2245-67.
- Rosenwasser LJ, Mahr T, Abelson MB, et al. A comparison of olopatadine 0.2% ophthalmic solution versus fluticasone furoate nasal spray for the treatment of allergic conjunctivitis. Allergy Asthma Proc 2008;29:644-653.
Ocular Antihistamine/Mast-Cell Stabilizers and Nasal SymptomsIn addition to the bepotastine 1.5% study results cited in the accompanying article, data are available on the nasal effects of other ocular antihistamine/mast-cell stabilizing medications. The nasal effects of olopatadine HCl ophthalmic solution 0.2% (Pataday, Alcon Laboratories, Inc.) were evaluated in two randomized, placebo-controlled, double-masked, hybrid environmental studies.1 The two studies had a combined enrollment of 500 patients with histories of seasonal allergic conjunctivitis or rhinoconjunctivitis. One study was conducted over 10 weeks in the spring. The other was conducted over 12 weeks in the fall. In both, patients assessed their ocular signs and symptoms. In addition, patients in the spring study reported the frequency of their nasal symptoms, and patients in the fall study reported both the frequency and severity of their nasal symptoms. Each day during the studies, ragweed (fall study) or grass (spring study) pollen counts were obtained from each investigative center. According to the published results, in the spring study, relative to placebo, olopatadine significantly reduced the frequency of pollen effects on sneezing (p = 0.0017) and runny nose (p = 0.0031). In the fall study, relative to placebo, olopatadine significantly reduced the frequency of pollen effects on sneezing (p = 0.0355) and itchy nose (p = 0.0032) and reduced the severity of pollen effects on sneezing (p = 0.0451), itchy nose (p = 0.0178) and runny nose (p = 0.0327). The nasal effects of epinastine HCl ophthalmic solution 0.05% (Elestat, Allergan Inc., and Inspire Pharmaceuticals Inc.) were assessed within a single-center, randomized, single-dose, paired-eye, double-masked observational study.2 Patients enrolled in the study had a history of ocular allergy to cats, positive skin-prick test and itching score ≥ 2 (scale of 0-4) in a cat exposure room. Subjects were again placed in a cat exposure room, which contained levels of airborne Fel d1 cat allergen comparable to those of cat-containing homes. Signs and symptoms of allergic conjunctivitis were recorded after 30 minutes of exposure. Ocular itching, ocular burning, tearing, nasal itching and rhinorrhea were graded on a 0-4 scale. Immediately prior to instillation of the study drugs, mean baseline scores for epinastine-treated eyes were 0.90 for nasal itching and 0.70 for rhinorrhea. (The researchers noted that the study subjects wore TB masks.) A drop of epinastine was instilled in one eye, and a drop of olopatadine 0.1% was instilled in the other eye, and symptoms were reassessed at various time points. After 60 minutes, epinastine-treated eyes showed significant decreases in nasal itching (p = 0.006) and rhinorrhea (p = 0.043). 1. Abelson MB, Gomes PJ, Vogelson CT, et al. Effects of a new formulation of olopatadine ophthalmic solution on nasal symptoms relative to placebo in two studies involving subjects with allergic conjunctivitis or rhinoconjunctivitis. Curr Med Res Opin 2005;21(5):683-691. 2. Monson BK, Rothman JA, Raizman MB. Efficacy of epinastine ophthalmic solution for post-exposure treatment of signs and symptoms of allergic conjunctivitis in cat-sensitive subjects. Poster P254. Presented at the Annual Meeting of the American College of Allergy, Asthma, and Immunology, Nov. 12-17, 2004, Boston, MA. |