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...
| Main Authors: | , , , , , |
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| Format: | Article |
| Language: | English |
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Dove Medical Press
2018-12-01
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| Series: | Clinical Ophthalmology |
| Subjects: | |
| Online Access: | https://www.dovepress.com/safety-and-efficacy-of-twice-daily-administration-of-kpi-121-1-for-ocu-peer-reviewed-article-OPTH |
| _version_ | 1818434339194535936 |
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| 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 |
| collection | DOAJ |
| 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 |
| first_indexed | 2024-12-14T16:35:25Z |
| format | Article |
| id | doaj.art-85e137a6ee1d4a6aa393eb7e8b46a830 |
| institution | Directory Open Access Journal |
| issn | 1177-5483 |
| language | English |
| last_indexed | 2024-12-14T16:35:25Z |
| publishDate | 2018-12-01 |
| publisher | Dove Medical Press |
| record_format | Article |
| series | Clinical Ophthalmology |
| spelling | doaj.art-85e137a6ee1d4a6aa393eb7e8b46a8302022-12-21T22:54:28ZengDove Medical PressClinical Ophthalmology1177-54832018-12-01Volume 13698643271Safety and efficacy of twice daily administration of KPI-121 1% for ocular inflammation and pain following cataract surgeryKim TSall KHolland EJBrazzell RKCoultas SGupta PKTerry 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, painhttps://www.dovepress.com/safety-and-efficacy-of-twice-daily-administration-of-kpi-121-1-for-ocu-peer-reviewed-article-OPTHloteprednol etabonatenanoparticlecataract surgerypost-operative ocular inflammationpain |
| spellingShingle | 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 Clinical Ophthalmology loteprednol etabonate nanoparticle cataract surgery post-operative ocular inflammation pain |
| title | 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_short | 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 |
| topic | loteprednol etabonate nanoparticle cataract surgery post-operative ocular inflammation pain |
| url | https://www.dovepress.com/safety-and-efficacy-of-twice-daily-administration-of-kpi-121-1-for-ocu-peer-reviewed-article-OPTH |
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