Safety and efficacy of twice daily administration of KPI-121 1% for ocular inflammation and pain following cataract surgery

Terry Kim,1 Kenneth Sall,2 Edward J Holland,3 R Kim Brazzell,4 Susan Coultas,4 Preeya K Gupta1 1Department of Ophthalmology, Duke University Eye Center, Durham, NC, USA; 2Sall Research Medical Center, Inc, Artesia, CA, USA; 3Department of Ophthalmology, Cincinnati Eye Institute, University of Cinci...

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Autores principales:	Kim T, Sall K, Holland EJ, Brazzell RK, Coultas S, Gupta PK
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2018
Materias:	loteprednol etabonate nanoparticle cataract surgery post-operative ocular inflammation pain Ophthalmology RE1-994
Acceso en línea:	https://doaj.org/article/85e137a6ee1d4a6aa393eb7e8b46a830
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spelling	oai:doaj.org-article:85e137a6ee1d4a6aa393eb7e8b46a8302021-12-02T07:00:29ZSafety and efficacy of twice daily administration of KPI-121 1% for ocular inflammation and pain following cataract surgery1177-5483https://doaj.org/article/85e137a6ee1d4a6aa393eb7e8b46a8302018-12-01T00:00:00Zhttps://www.dovepress.com/safety-and-efficacy-of-twice-daily-administration-of-kpi-121-1-for-ocu-peer-reviewed-article-OPTHhttps://doaj.org/toc/1177-5483Terry Kim,1 Kenneth Sall,2 Edward J Holland,3 R Kim Brazzell,4 Susan Coultas,4 Preeya K Gupta1 1Department of Ophthalmology, Duke University Eye Center, Durham, NC, USA; 2Sall Research Medical Center, Inc, Artesia, CA, USA; 3Department of Ophthalmology, Cincinnati Eye Institute, University of Cincinnati, Cincinnati, OH, USA; 4Kala Pharmaceuticals, Inc, Waltham, MA, USA Purpose: KPI-121 is a nanoparticle suspension of loteprednol etabonate with improved ocular pharmacokinetics compared with marketed formulations. The efficacy and safety of KPI-121 1% ophthalmic suspension (INVELTYS™) dosed twice daily (BID) were evaluated in participants who had undergone cataract surgery. Materials and methods: In two multicenter, randomized, double-masked, parallel-group, vehicle-controlled clinical trials, 386 participants with ≥ grade 2 anterior chamber cells (≥6 cells) on the day following routine cataract surgery were treated with KPI-121 1% and 325 participants were treated with placebo (vehicle); each group was dosed BID for 2 weeks. Primary efficacy endpoints were complete resolution of ocular inflammation by slit-lamp biomicroscopy and complete resolution of subject-rated ocular pain at Days 8 and 15 with no rescue medication before Day 15. Safety assessments included adverse events (AEs), visual acuity, intraocular pressure measurements, and evaluation of ocular AEs by slit-lamp biomicroscopy and dilated ophthalmoscopy. Results: Both trials achieved statistical significance favoring KPI-121 1% BID for both primary efficacy endpoints. Combined data analysis showed that significantly more participants treated with KPI-121 vs vehicle achieved complete resolution of anterior chamber cells at Days 8 and 15 (P≤0.0001) and complete clearing of ocular pain at Days 4, 8, and 15 (P<0.0001). AEs were reported more frequently with vehicle than KPI-121. Conclusion: KPI-121 1% ophthalmic suspension was effective in resolving postoperative ocular inflammation and pain when dosed BID for 2 weeks in patients following cataract surgery. KPI-121 was found to be safe and well tolerated in both trials. Keywords: loteprednol etabonate, nanoparticle, mucus penetrating particles, postoperative ocular inflammation, painKim TSall KHolland EJBrazzell RKCoultas SGupta PKDove Medical Pressarticleloteprednol etabonatenanoparticlecataract surgerypost-operative ocular inflammationpainOphthalmologyRE1-994ENClinical Ophthalmology, Vol Volume 13, Pp 69-86 (2018)
institution	DOAJ
collection	DOAJ
language	EN
topic	loteprednol etabonate nanoparticle cataract surgery post-operative ocular inflammation pain Ophthalmology RE1-994
spellingShingle	loteprednol etabonate nanoparticle cataract surgery post-operative ocular inflammation pain Ophthalmology RE1-994 Kim T Sall K Holland EJ Brazzell RK Coultas S Gupta PK Safety and efficacy of twice daily administration of KPI-121 1% for ocular inflammation and pain following cataract surgery
description	Terry Kim,1 Kenneth Sall,2 Edward J Holland,3 R Kim Brazzell,4 Susan Coultas,4 Preeya K Gupta1 1Department of Ophthalmology, Duke University Eye Center, Durham, NC, USA; 2Sall Research Medical Center, Inc, Artesia, CA, USA; 3Department of Ophthalmology, Cincinnati Eye Institute, University of Cincinnati, Cincinnati, OH, USA; 4Kala Pharmaceuticals, Inc, Waltham, MA, USA Purpose: KPI-121 is a nanoparticle suspension of loteprednol etabonate with improved ocular pharmacokinetics compared with marketed formulations. The efficacy and safety of KPI-121 1% ophthalmic suspension (INVELTYS™) dosed twice daily (BID) were evaluated in participants who had undergone cataract surgery. Materials and methods: In two multicenter, randomized, double-masked, parallel-group, vehicle-controlled clinical trials, 386 participants with ≥ grade 2 anterior chamber cells (≥6 cells) on the day following routine cataract surgery were treated with KPI-121 1% and 325 participants were treated with placebo (vehicle); each group was dosed BID for 2 weeks. Primary efficacy endpoints were complete resolution of ocular inflammation by slit-lamp biomicroscopy and complete resolution of subject-rated ocular pain at Days 8 and 15 with no rescue medication before Day 15. Safety assessments included adverse events (AEs), visual acuity, intraocular pressure measurements, and evaluation of ocular AEs by slit-lamp biomicroscopy and dilated ophthalmoscopy. Results: Both trials achieved statistical significance favoring KPI-121 1% BID for both primary efficacy endpoints. Combined data analysis showed that significantly more participants treated with KPI-121 vs vehicle achieved complete resolution of anterior chamber cells at Days 8 and 15 (P≤0.0001) and complete clearing of ocular pain at Days 4, 8, and 15 (P<0.0001). AEs were reported more frequently with vehicle than KPI-121. Conclusion: KPI-121 1% ophthalmic suspension was effective in resolving postoperative ocular inflammation and pain when dosed BID for 2 weeks in patients following cataract surgery. KPI-121 was found to be safe and well tolerated in both trials. Keywords: loteprednol etabonate, nanoparticle, mucus penetrating particles, postoperative ocular inflammation, pain
format	article
author	Kim T Sall K Holland EJ Brazzell RK Coultas S Gupta PK
author_facet	Kim T Sall K Holland EJ Brazzell RK Coultas S Gupta PK
author_sort	Kim T
title	Safety and efficacy of twice daily administration of KPI-121 1% for ocular inflammation and pain following cataract surgery
title_short	Safety and efficacy of twice daily administration of KPI-121 1% for ocular inflammation and pain following cataract surgery
title_full	Safety and efficacy of twice daily administration of KPI-121 1% for ocular inflammation and pain following cataract surgery
title_fullStr	Safety and efficacy of twice daily administration of KPI-121 1% for ocular inflammation and pain following cataract surgery
title_full_unstemmed	Safety and efficacy of twice daily administration of KPI-121 1% for ocular inflammation and pain following cataract surgery
title_sort	safety and efficacy of twice daily administration of kpi-121 1% for ocular inflammation and pain following cataract surgery
publisher	Dove Medical Press
publishDate	2018
url	https://doaj.org/article/85e137a6ee1d4a6aa393eb7e8b46a830
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Safety and efficacy of twice daily administration of KPI-121 1% for ocular inflammation and pain following cataract surgery

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