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

Publication ,  Journal Article
Kim, T; Sall, K; Holland, EJ; Brazzell, RK; Coultas, S; Gupta, PK
Published in: Clin Ophthalmol
2019

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.

Duke Scholars

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Published In

Clin Ophthalmol

DOI

ISSN

1177-5467

Publication Date

2019

Volume

13

Start / End Page

69 / 86

Location

New Zealand

Related Subject Headings

  • 3212 Ophthalmology and optometry
  • 1113 Opthalmology and Optometry
 

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ICMJE
MLA
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Kim, T., Sall, K., Holland, E. J., Brazzell, R. K., Coultas, S., & Gupta, P. K. (2019). Safety and efficacy of twice daily administration of KPI-121 1% for ocular inflammation and pain following cataract surgery. Clin Ophthalmol, 13, 69–86. https://doi.org/10.2147/OPTH.S185800
Kim, Terry, Kenneth Sall, Edward J. Holland, R Kim Brazzell, Susan Coultas, and Preeya K. Gupta. “Safety and efficacy of twice daily administration of KPI-121 1% for ocular inflammation and pain following cataract surgery.Clin Ophthalmol 13 (2019): 69–86. https://doi.org/10.2147/OPTH.S185800.
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. Clin Ophthalmol. 2019;13:69–86.
Kim, Terry, et al. “Safety and efficacy of twice daily administration of KPI-121 1% for ocular inflammation and pain following cataract surgery.Clin Ophthalmol, vol. 13, 2019, pp. 69–86. Pubmed, doi:10.2147/OPTH.S185800.
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. Clin Ophthalmol. 2019;13:69–86.

Published In

Clin Ophthalmol

DOI

ISSN

1177-5467

Publication Date

2019

Volume

13

Start / End Page

69 / 86

Location

New Zealand

Related Subject Headings

  • 3212 Ophthalmology and optometry
  • 1113 Opthalmology and Optometry