Optivar (Azelastine Hydrochloride Ophthalmic) - Summary

OPTIVAR SUMMARY

OPTIVAR® (azelastine hydrochloride ophthalmic solution), 0.05% is a sterile ophthalmic solution containing azelastine hydrochloride, a relatively selective H₁-receptor antagonist for topical administration to the eyes.

OPTIVAR® is indicated for the treatment of itching of the eye associated with allergic conjunctivitis.

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NEWS HIGHLIGHTS

Media Articles Related to Optivar (Azelastine Ophthalmic)

ISTA Pharmaceuticals Highlights Bepreve(TM) Clinical Data At The American College Of Clinical Pharmacy (ACCP) 2009 Annual Meeting
Source: Allergy News From Medical News Today [2009.10.22]
ISTA Pharmaceuticals, Inc. (Nasdaq: ISTA) announced poster presentations of results from the Company's Bepreve(TM) (bepotastine besilate ophthalmic solution) 1.5% Phase 3 clinical studies in allergic conjunctivitis. The studies demonstrated Bepreve was safe and well-tolerated when given twice daily for six weeks in a healthy pediatric population as young as three years of age.

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Published Studies Related to Optivar (Azelastine Ophthalmic)

Double-blind, placebo-controlled trial of reformulated azelastine nasal spray in patients with seasonal allergic rhinitis. [2009.09]
BACKGROUND: Azelastine nasal spray is a topical antihistamine with a distinctive taste that may be objectionable to some patients. The primary objectives of this clinical trial were (1) to determine if a reformulated azelastine nasal spray (Astepro) with sucralose as a taste-masking agent provides comparable efficacy to the original formulation (Astelin) and (2) to evaluate dose-response relationships between groups... CONCLUSION: The results of this study showed efficacy both with original azelastine nasal spray and with the reformulated nasal spray and a clear dose-response difference between the 1- and 2-spray dosages.

Combination therapy with azelastine hydrochloride nasal spray and fluticasone propionate nasal spray in the treatment of patients with seasonal allergic rhinitis. [2008.01]
BACKGROUND: To our knowledge, there are no published studies that evaluated the efficacy of azelastine hydrochloride nasal spray in combination with an intranasal corticosteroid, although anecdotal reports of the use of these agents in combination are common. OBJECTIVE: To determine if greater efficacy could be achieved with the intranasal antihistamine azelastine and the intranasal corticosteroid fluticasone propionate used concurrently compared with the efficacy of each agent alone... CONCLUSIONS: The significant improvement in the TNSS with combination therapy relative to the individual agents alone is in contrast to previously published studies that found no advantage with an oral antihistamine and an intranasal corticosteroid in combination. Azelastine nasal spray and fluticasone nasal spray in combination may provide a substantial therapeutic benefit for patients with seasonal allergic rhinitis compared with therapy with either agent alone.

Effect of azelastine, montelukast, and their combination on allergen-induced bronchoconstriction in asthma. [2008]
OBJECTIVES: Histamine and cysteinyl leukotrienes play an important role in early (EAR) and late (LAR) allergen reactions. Although protection by anti-histamines and anti-leukotrienes has been studied extensively, little is known about the effect of their combination. We, therefore, assessed the effect of clinically recommended doses of azelastine and montelukast alone and in combination on EAR and LAR... CONCLUSION: The combination of azelastine and montelukast in clinically recommended doses has a greater effect in suppressing early and late allergen reactions than each drug alone.

Effectiveness of azelastine nasal spray compared with oral cetirizine in patients with seasonal allergic rhinitis. [2005.05]
BACKGROUND: Azelastine nasal spray and oral cetirizine are selective histamine H(1)-receptor antagonists that are approved in the United States for the treatment of seasonal allergic rhinitis (SAR). OBJECTIVE: The objective of the present study was to compare the efficacy and tolerability of azelastine nasal spray administered at the recommended dosage of 2 sprays per nostril twice daily with those of cetirizine in the treatment of moderate to severe SAR... CONCLUSION: In this 2-week study in patients with moderate to severe SAR, azelastine nasal spray was well tolerated and produced significantly greater improvements in TNSS and total RQLQ score compared with cetirizine.

Efficacy of azelastine nasal spray in seasonal allergic rhinitis patients who remain symptomatic after treatment with fexofenadine. [2004.08]
BACKGROUND: Currently available oral second-generation antihistamines do not provide adequate symptom relief for many allergy patients. OBJECTIVE: To determine the ability of azelastine nasal spray to improve rhinitis symptoms in patients with seasonal allergic rhinitis who remained symptomatic after treatment with fexofenadine... CONCLUSIONS: Azelastine nasal spray is effective monotherapy for patients who remain symptomatic after treatment with fexofenadine and should be considered in the initial management of patients with seasonal allergic rhinitis.

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Clinical Trials Related to Optivar (Azelastine Ophthalmic)

A Study to Evaluate the Safety and Effectiveness of a Nasal Spray to Treat Seasonal Allergies [Completed]
The purpose of this study is to determine if two allergy medications (azelastine and fluticasone) are more effective than placebo or either medication alone (azelastine or fluticasone)

A Study to Evaluate the Safety and Effectiveness of a Nasal Spray to Treat Seasonal Allergies [Active, not recruiting]
The purpose of this study is to determine if two allergy medications (azelastine and fluticasone) are more effective than placebo or either medication alone (azelastine or fluticasone)

A Phase II Study Evaluating Intranasal GSK256066 and Azelastine Hydrochloride in Subjects With Seasonal Allergic Rhinitis [Not yet recruiting]
This study is an 8 day, randomised, double blind, 2-way crossover trial of repeat doses of intranasal GSK256066 and azelastine hydrochloride in the Vienna Challenge Chamber in subjects with seasonal allergic rhinitis (SAR). Laboratory safety assessments, 12-lead electrocardiograph (ECG), vital signs and adverse event enquiries will be made throughout the study. Nasal examination, symptom scores, and allergen challenge assessments will also be performed at various time points throughout the study.

Azelastine Fluticasone Combination vs. Fluticasone [Not yet recruiting]
The purpose of this study is to see how a combination spray of azelastine and fluticasone (antihistamine and steroid) compares with a steroid nasal spray (fluticasone) alone in allergic rhinitis i. e. does azelastine permit the use of lesser steroid dose (steroid sparing effect) to achieve the same benefit.

Safety and Efficacy of Olopatadine 0.6% and Azelastine 137 Mcg in Vasomotor Rhinitis [Recruiting]

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PATIENT REVIEWS / RATINGS / COMMENTS

Optivar review by 36 year old female patient
		Rating
Overall rating:
Effectiveness:		Considerably Effective
Side effects:		Moderate Side Effects
		Treatment Info
Condition / reason:		dry, allergic eyes
Dosage & duration:		1 drop 2x/day (dosage frequency: 1x) for the period of 1x
Other conditions:		eye fatigue
Other drugs taken:		none
		Reported Results
Benefits:		relieved some of the itching
Side effects:		blurred vision for 90 seconds after administering; burning sensation
Comments:		Was prescribed for 1 month for dry, itchy eyes. I took Optivar for 5 days, then called the ophtamologist about the burning sensation. He advised me to discontinue the Optivar and wrote a prescription for Alrex.