Phase 3 Randomized Double-Masked Study of Efficacy and Safety of Once-Daily 0.77% Olopatadine Hydrochloride Ophthalmic Solution in Subjects With Allergic Conjunctivitis Using the Conjunctival Allergen Challenge Model

McLaurin, Eugene; Narvekar, Abhijit; Gomes, Paul J; Adewale, Adeniyi J.; Torkildsen, Gail

doi:10.1097/ico.0000000000000562

Cited by 15 publications

(31 citation statements)

References 17 publications

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“…The new ophthalmic formulation of olopatadine at an increased concentration of 0.77% was developed with the aim to increase the aqueous solubility of olopatadine at neutral pH and to provide better efficacy in the management of ocular allergy compared with the previously approved olopatadine ophthalmic formulations (0.1% and 0.2%). Superior efficacy of olopatadine 0.77% over 0.1% and 0.2% formulations was recently shown in Phase III clinical trials 14,15. In a pre-clinical study, olopatadine 0.77% formulation showed improved solubility and a 4-fold increase in the concentration of olopatadine in the aqueous humor when compared to olopatadine 0.2%, with no sign of capacity-limit kinetics 16.…”

Section: Discussionmentioning

confidence: 93%

“…In a preclinical study, olopatadine was observed at higher concentrations with prolonged presence in the target tissue (rabbit conjunctiva) following dosing with olopatadine 0.77% compared to that with olopatadine 0.2% 16. The new olopatadine 0.77% formulation has demonstrated a longer, 24-hour duration of action and superior efficacy compared to olopatadine 0.2% formulation in Phase III clinical studies 14,15. This new formulation of olopatadine 0.77% (marketed as PAZEO ® by Alcon Research Ltd.) was approved by the US Food and Drug Administration (FDA) in 2015 as once-daily product for the treatment of ocular itching associated with allergic conjunctivitis.…”

Section: Introductionmentioning

confidence: 99%

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Pharmacokinetics and safety of olopatadine hydrochloride 0.77% in healthy subjects with asymptomatic eyes: data from 2 independent clinical studies

Meier

Narvekar

Iyer

et al. 2017

OPTH

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PurposeTo assess the pharmacokinetics and safety of hydrochloride ophthalmic solution 0.77% olopatadine from 2 independent (Phase I and Phase III, respectively) clinical studies in healthy subjects.Materials and methodsThe Phase I, multicenter, randomized (2:1), vehicle-controlled study was conducted in subjects ≥18 years old (N=36) to assess the systemic pharmacokinetics of olopatadine 0.77% following single- and multiple-dose exposures. The Phase III, multicenter, randomized (2:1), vehicle-controlled study was conducted in subjects ≥2 years old (N=499) to evaluate long-term ocular safety of olopatadine 0.77%. Subjects received olopatadine 0.77% or vehicle once daily bilaterally for 7 days in the pharmacokinetic study and 6 weeks in the safety study.ResultsIn the pharmacokinetic study, olopatadine 0.77% was absorbed slowly and reached a peak plasma concentration (Cmax) of 1.65 ng/mL following single-dose and 1.45 ng/mL following multiple-dose exposures in 2 hours (time to reach maximum plasma concentration [Tmax]). After reaching peak concentrations, olopatadine showed a similar mono-exponential decay following single and multiple doses with mean elimination half-life ranging from 2.90 to 3.40 hours. No accumulation in olopatadine exposure (Cmax and area under the plasma concentration–time curve from 0 to 12 hours) was evident after multiple doses when compared to single dose. In the safety study, treatment-emergent adverse events were reported in 26.7% and 31.4% of subjects with olopatadine 0.77% and vehicle, respectively. Blurred vision was the most frequent ocular treatment-emergent adverse event in both treatment groups (olopatadine 0.77% vs vehicle, 4.8% vs 4.1%). No deaths or serious adverse events were reported during the study.ConclusionOlopatadine 0.77% had minimal systemic exposure or accumulation in healthy subjects and was well tolerated in both adult and pediatric subjects.

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Section: Discussionmentioning

confidence: 93%

Section: Introductionmentioning

confidence: 99%

Pharmacokinetics and safety of olopatadine hydrochloride 0.77% in healthy subjects with asymptomatic eyes: data from 2 independent clinical studies

Meier

Narvekar

Iyer

et al. 2017

OPTH

Self Cite

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show abstract

“…53 At 3, 5, and 7 minutes after CAC, ocular itch reduction with olopatadine 0.77% was superior to vehicle at onset and 24 hours after instillation (Fig. 3 A ) and to active control formulations 24 hours after instillation (Fig.…”

Section: Benefits Of a True 24-hour Topical Medicationmentioning

confidence: 89%

“…In both studies, adverse events and other safety parameters were similar across treatment groups, and the safety profile of olopatadine 0.77% was similar to that of olopatadine 0.2%. 52,53 Together, these trials indicate that olopatadine 0.77% is more effective and maintains a longer duration of action compared with currently available olopatadine formulations and that once-daily olopatadine 0.77% provides an effective 24-hour control of AC signs and symptoms.…”

Section: Benefits Of a True 24-hour Topical Medicationmentioning

confidence: 93%

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Treating Allergic Conjunctivitis: A Once-daily Medication that Provides 24-hour Symptom Relief

Carr

Schaeffer²,

Donnenfeld

2016

Allergy�Rhinol (Providence)

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PAF‐induced inflammatory and immuno‐allergic ophthalmic diseases and their mitigation with PAF receptor antagonists: Cell and nuclear effects

Sharif

2022

BioFactors

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Ocular allergies are becoming more prevalent as more airborne pollutants, irritants and microbes pervade our environment. Inflammatory and allergic mediators released by dendritic and mast cells within the conjunctiva cause allergic conjunctivitis (AC), a prevalent ocular surface disorder that affects >40% of the world's human population on a seasonal or perennial basis. Even though histamine is a major culprit, platelet‐activating factor (PAF) also contributes to AC, acting either directly or synergistically with histamine and other mediators. PAF receptor‐meditated inflammatory reactions, via cell‐membrane‐bound and nuclear‐membrane‐bound and nuclear PAF receptors, are also implicated in the etiology of other eye diseases such as uveitis, diabetic retinopathy, corneal and choroidal neovascularization, and age‐related macular degeneration which cause serious visual impairment and can lead to blindness. This review highlights the various deleterious elements implicated in the pathological aspects of ocular allergic reactions and inflammation and provides concepts and treatment options to mitigate these eye disorders with a special focus on PAF and PAF receptor antagonists.

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Phase 3 Randomized Double-Masked Study of Efficacy and Safety of Once-Daily 0.77% Olopatadine Hydrochloride Ophthalmic Solution in Subjects With Allergic Conjunctivitis Using the Conjunctival Allergen Challenge Model

Abstract: Olopatadine 0.77% demonstrated a rapid onset and prolonged duration of action. It was superior to all comparators in alleviating AC-associated ocular itching with a favorable safety profile.Clinical Trial Registration-URL: http://www.clinicaltrials.gov. Unique identifier: NCT01743027.

Cited by 15 publications

References 17 publications

Pharmacokinetics and safety of olopatadine hydrochloride 0.77% in healthy subjects with asymptomatic eyes: data from 2 independent clinical studies

Pharmacokinetics and safety of olopatadine hydrochloride 0.77% in healthy subjects with asymptomatic eyes: data from 2 independent clinical studies

Treating Allergic Conjunctivitis: A Once-daily Medication that Provides 24-hour Symptom Relief

PAF‐induced inflammatory and immuno‐allergic ophthalmic diseases and their mitigation with PAF receptor antagonists: Cell and nuclear effects

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