Ophthalmic Antihistamine Step Therapy Program Summary

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1 Ophthalmic Antihistamine Step Therapy Program Summary FDA APPROVED INDICATIONS AND DOSAGE 1-8 Drug FDA Indication(s) Administration and Dosing Bepreve Treatment of itching associated Instill one drop into the affected (bepotastine) with allergic eye(s) twice a day. 1.5% ophthalmic solution Elestat (epinastine) a 0.05% ophthalmic solution a Emadine (emedastine) 0.05% ophthalmic solution Lastacaft (alcaftadine) 0.25% ophthalmic solution Optivar (azelastine) a 0.05% ophthalmic solution Patanol (olopatadine) a 0.1% ophthalmic solution Pataday (olopatadine) 0.2% ophthalmic solution Pazeo (olopatadine) 0.07% ophthalmic solution Prevention of itching associated with allergic Temporary relief of the signs and symptoms of allergic Prevention of itching associated with allergic Treatment of itching of the eye Treatment of the signs and symptoms of allergic Treatment of ocular itching Treatment of ocular itching One drop in each eye twice a day. One drop in the effected eye up to four times daily. Instill one drop in each eye once daily. One drop instilled into each affected eye twice a day. two times per day at an interval of 6 to 8 hours. once a day. once a day. CLINICAL RATIONALE An algorithm on treatment of allergic conjunctivitis (2013) uses a step wise approach, suggesting cold compresses, artificial tears, and OTC ophthalmic agents (e.g., pheniramine/naphazoline, ketotifen) as first line treatments for mild cases. Then if symptoms continue, or if OTC agents are not effective or not tolerated, prescription agents are recommended. Topical ophthalmic agents for the treatment of ocular allergy have a more rapid onset of action vs. oral antihistamines and are generally better tolerated. Topical antihistamines do not cause significant systemic side effects and generally do not contribute to ocular dryness. In clinical trials, dual-acting agents (e.g., ketotifen) have been shown to effectively reduce Choice_PS_Ophthalmic_Antihistamines_ST_ProgSum_0117_r0317_v2 Page 1 of 5

2 itching conjunctivitis with longer duration of effect and better tolerability than single-action antihistamines. 9 The American Academy of Asthma, Allergy, and Immunology (AAAI) states OTC antihistamine pills and eye drops are often used for short-term treatment of eye allergy symptoms. However, prolonged use of some eye drops may actually make symptoms worse. 10 For seasonal allergic conjunctivitis, the American Academy of Ophthalmology (AAO, 2013) suggests mild cases may be treated with an over-the-counter (OTC) antihistamine/vasoconstrictor (e.g., naphazoline/pheniramine), or with a more effective secondgeneration topical histamine H1-receptor antagonist (e.g., emedastine, alcaftadine). If the condition is frequently recurrent or persistent, mast cell stabilizers (e.g., cromolyn, lodoxamide, nedocromil) may be used to maintain comfort. Ophthalmic allergy preparations with dual antihistamine and mast-cell stabilizing properties, (e.g., ketotifen [OTC], azelastine, bepotastine, epinastine, olopatadine) may be used for either acute or chronic disease. There is no preference for one particular product in each class over the others. 11 Numerous comparative trials using allergic conjunctivitis agents have been conducted. From the results of the trials, it is difficult to declare one agent superior to another. 12,13,14 A meta-analysis of 8 studies compared the efficacy of the treatment of allergic conjunctivitis with topical antihistamines versus topical mast cell stabilizers, Results showed no significant differences being recorded in favor of any of the interventions. 15 Efficacy Alcaftadine 16 Fifty-eight subjects with a history of allergic conjunctivitis were enrolled in a double-masked, multicenter, vehicle-controlled study. Outcome measures were ocular itching and conjunctival redness. The signs and symptoms of allergic conjunctivitis were induced in the subjects by a conjunctival allergen challenge (CAC). The subjects were randomized to be given either one drop of alcaftadine 0.25% ophthalmic solution bilaterally or vehicle bilaterally. Alcaftadine significantly lessened conjunctival redness after both 15 minutes and 16 hours of the drug administration (p<0.001 vs. vehicle). Azelastine 5 In a conjunctival antigen challenge study, azelastine was more effective than vehicle in preventing itching In environmental studies, patients with seasonal allergic conjunctivitis were treated with azelastine or vehicle. In these studies azelastine was significantly more effective in relieving itching Bepotastine 17,18 Two Phase III, placebo-controlled, double-masked, randomized clinical trials in patients with allergic conjunctivitis assessed the efficacy of bepotastine besilate (BBOS) vs. placebo. The same study design was employed for both clinical trials, with subjects randomly assigned to either BBOS 1.5% (n=78) or placebo (n=79) treatment. Primary ocular end points included changes in ocular itching reported at 3, 5, and 7 minutes and conjunctival hyperemia assessed at 7, 15, and 20 minutes following each allergen challenge. Secondary ocular end points included chemosis as well as episcleral and ciliary hyperemia judged by investigators, and tearing (scored as either absent or present) and eyelid swelling judged by subjects. A statistically significant reduction in ocular itching was observed for BBOS 1.5% treatment compared to placebo at all time points (P<0.0001). Secondary end points were also significantly improved compared to placebo, most prominently for reduced tearing (no P value listed). Emedastine 19 Choice_PS_Ophthalmic_Antihistamines_ST_ProgSum_0117_r0317_v2 Page 2 of 5

3 Thirty-six subjects with allergic conjunctivitis were randomized into two groups in a doubleblind, single-center crossover study comparing emedastine 0.05% and ketorolac 0.5%. The first group received emedastine 0.05% in one eye and placebo in the other eye. The second group received ketorolac 0.5% in one eye and placebo in the other eye. Ten minutes after instillation, patients underwent allergen challenge. After the challenge, patients graded ocular itching and were assessed for hyperemia. Approximately 14 days later, subjects entered the crossover treatment phase. Emedastine 0.05% significantly inhibited ocular itching and redness (p<0.05). Epinastine 20 A prospective, single-center, randomized, double-masked, vehicle-controlled, Phase III clinical trial assessed the efficacy and tolerability of epinastine using the conjunctival antigen challenge in 67 patients with a history of allergic Patients were randomly assigned by eye to receive epinastine hydrochloride 0.05% ophthalmic solution in 1 eye and vehicle in the contralateral eye. Primary end points were ocular itching and conjunctival hyperemia. Itching was recorded 3, 5, and 10 minutes after antigen challenge. Hyperemia was recorded 5, 10, and 20 minutes after antigen challenge, as were secondary end points, which included eyelid swelling, episcleral and ciliary hyperemia, chemosis, tearing, and ocular mucous discharge. Mean severity scores for the following signs and symptoms were significantly lower with epinastine compared with vehicle at all time points after onset and duration challenges: ocular itching (P<0.001); eyelid swelling (P<0.001); conjunctival ( P<0.001), episcleral ( P<0.001), and ciliary hyperemia (P<0.001); and chemosis (P<or=0.009). Olopatadine Using the conjunctival an allergen challenge test, one dose of ophthalmic olopatadine 0.2% was comparable to two doses of ophthalmic olopatadine 0.1%, and both regimens were more effective than placebo in terms of mean itching scores in a small clinical trial. Olopatadine 0.7% was studied in two randomized, double-masked, placebo-controlled, conjunctival allergen challenge clinical studies. 21 Olopatadine 0.7% demonstrated statistically significantly improved relief of ocular itching compared to vehicle at minutes, 16 hours, and 24 hours after study treatment. Olopatadine 0.7% demonstrated statistically significantly improved relief of ocular itching compared to olopatadine 0.2% at 24 hours after study treatment, but not at minutes after study treatment. 8 Safety Common adverse effects of these agents include stinging and burning upon administration, eyelid edema and rhinitis. 22,23 Headache is also a common side effect with these agents. Of note, it occurs often in treatment with emedastine (11%), olopatadine (7%), bepotastine (2-5%), epinastine (1-3%), and azelastine (15%). 22 REFERENCES 1. Bepreve prescribing information. ISTA Pharmaceuticals, Inc. June Elestat prescribing information. Allergan, Inc. June Emadine prescribing information. Alcon Laboratories, Inc. May Lastacaft prescribing information. Allergan, Inc. December Optivar prescribing information. Meda Pharmaceuticals, Inc. July Patanol prescribing information. Alcon Laboratories, Inc. April Pataday prescribing information. Alcon Laboratories, Inc. December Pazeo prescribing information. Alcon Laboratories, Inc. January An algorithm for the management of allergic Allergy & Asthma Proceedings. 2013:34(5): Ocular symptoms, treatment and diagnosis. American Academy of Allergy, Asthma, and Immunology. (2014). Accessed 1/2/2015 at: Choice_PS_Ophthalmic_Antihistamines_ST_ProgSum_0117_r0317_v2 Page 3 of 5

4 11. Preferred Practice Pattern: Conjunctivitis. American Academy of Ophthalmology Accessed 1/2/2015 at: Multicenter Clinical Evaluation of Bepotastine Besilate Ophthalmic Solutions 1.0% and 1.5% to Treat Allergic Conjunctivitis. American Journal Ophthalmology. 2010; 150(1): e Perception and quality of life associated with the use of olopatadine 0.2% (Pataday) in patients with active allergic Advances in Therapy. 2007:24(6): Efficacy of olopatadine ophthalmic solution 0.2% in reducing signs and symptoms of allergic Allergy & Asthma Proceedings. 2007:28(4): Topical treatments for seasonal allergic conjunctivitis: systematic review and metaanalysis of efficacy and effectiveness. British Journal General Practice. 2004;54: The safety and efficacy of alcaftadine 0.25% ophthalmic solution for the prevention of itching Current Medical Research and Opinion. 2011:27(3): Bepotastine Besilate Ophthalmic Solutions Clinical Study Group Time to onset and duration of action of the antihistamine bepotastine besilate ophthalmic solutions 1.0% and 1.5% in allergic conjunctivitis: a phase III, single-center, prospective, randomized, double-masked, placebo-controlled, conjunctival allergen challenge assessment in adults and children. Clinical Therapy. 2009;31: Multicenter Clinical Evaluation of Bepotastine Besilate Ophthalmic Solutions 1.0% and 1.5% to Treat Allergic Conjunctivitis. American Journal of Ophthalmology. 2010;150: Comparison of the topical ocular antiallergic efficacy of emedastine 0.05% ophthalmic solution to ketorolac 0.5% ophthalmic solution in a clinical model of allergic Acta Ophthalmol Scand Suppl1; 228: Efficacy and tolerability of ophthalmic epinastine assessed using the conjunctival antigen challenge model in patients with a history of allergic Clinical Therapy. 2004;26(1): Evaluation of the efficacy of olopatadine hydrochloride 0.1% ophthalmic solution and azelastine hydrochloride 0.05% ophthalmic solution in the conjunctival allergen challenge model. Clinical Therapy (8): Ocular comfort and drying effects of three topical antihistamine/mast cell stabilizers in adults with allergic conjunctivitis: a randomized, double-masked crossover study. Clinical Therapy. 2008; 30(7): Topical treatments for seasonal allergic conjunctivitis: systematic review and metaanalysis of efficacy and effectiveness. British Journal of General Practice 2004;54: Choice_PS_Ophthalmic_Antihistamines_ST_ProgSum_0117_r0317_v2 Page 4 of 5

5 Ophthalmic Antihistamine Step Therapy OBJECTIVE The intent of the Ophthalmic Antihistamine Step Therapy (ST) program is to encourage use of cost-effective generic products over the more expensive brand products. This program will accommodate for use of brand products when generic prerequisites cannot be used due to previous trial and failure; or the patient has a documented intolerance, FDA labeled contraindication, or hypersensitivity. The program allows continuation of therapy when there is documentation that the patient is receiving the requested agent. Requests for brand products will be reviewed when patient-specific documentation is provided. TARGET DRUGS Bepreve (bepotastine) Elestat (epinastine) a Emadine (emedastine) Lastacaft (alcaftadine) Optivar (azelastine) a Patanol (olopatadine) a Pataday (olopatadine) Pazeo (olopatadine) a generic available PRI AUTHIZATION CRITERIA F APPROVAL Brand Ophthalmic Antihistamine will be approved when ONE of the following is met: 1. The patient s medication history indicates previous use of a generic ophthalmic antihistamine product in the past 90 days 2. There is documentation that the patient is currently using the requested agent 3. The prescriber states the patient is currently using the requested agent AND is at risk if therapy is changed 4. The patient has a documented intolerance, FDA labeled contraindication, or hypersensitivity to a generic ophthalmic antihistamine product Length of approval: 12 months Choice_PS_Ophthalmic_Antihistamines_ST_ProgSum_0117_r0317_v2 Page 5 of 5

Ophthalmic-1s: Antihistamine and Dual Acting Antihistamine/Mast Cell Stabilizers DHA Formulary Management Branch

May 2017 Antihistamine and Dual Acting Antihistamine/Mast Cell Stabilizers Executive Summary Page 1 of 5 Ophthalmic-1s: Antihistamine and Dual Acting Antihistamine/Mast Cell Stabilizers DHA Formulary Management