Safety of IBI-10090 for inflammation associated with cataract surgery: Phase 3 multicenter study

Donnenfeld, Eric D.; Solomon, Kerry D.; Matossian, Cynthia

doi:10.1016/j.jcrs.2018.07.015

Cited by 30 publications

(30 citation statements)

References 18 publications

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“…Intraocular DXM has been evaluated in two Phase 3 trials in patients undergoing cataract surgery; 10 , 11 a randomized, double-masked placebo-control trial in patients undergoing phacoemulsification; 10 and a randomized, open-label, active control trial comparing it with topical prednisolone acetate 1.0% ophthalmic suspension (QID for 3 weeks). 11 A pooled analysis of the phase 3 trials found that intraocular DXM was not an independent risk factor for postoperative intraocular pressure (IOP) increase, compared to conventional topical corticosteroid. 13 Intraocular DXM was comparable to the topical medication in overall safety, the primary study outcome, and in ACC clearing, an exploratory effectiveness endpoint.…”

Section: Introductionmentioning

confidence: 99%

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First Real-World, Multicenter, Post-Marketing, Retrospective Study of Dexamethasone Intraocular Suspension for Inflammation After Cataract Surgery

Bacharach¹,

McCabe²,

Jackson³

et al. 2022

OPTH

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Purpose To evaluate dexamethasone intraocular suspension 9% (intraocular DXM) in real-world clinical use to manage inflammation associated with cataract surgery. Setting Patients who underwent cataract surgery and received intraocular DXM at 22 outpatient eye surgery centers in the US. Design Retrospective, observational chart review. Methods Records of all patients who received intraocular DXM from March to December 2019 at participating centers were reviewed. Main Outcome Measures Outcomes included anterior chamber cell (ACC) grades, anterior chamber flare (ACF) grades, and visual acuity, as well as intraocular pressure (IOP) and adverse events (AEs) at postoperative days (PODs) 1, 8, 14, 30. Descriptive statistics were generated. Results The study population included 527 patients (641 eyes), with glaucoma history in 66 patients (80 eyes). Among eyes with recorded ACC grades, the percentage with grade 0 increased from 40% at POD 1 to 89.7% at POD 30, with similar results in eyes with glaucoma history. Among eyes with recorded ACF grades, the percentage with grade 0 increased from 78.4% at POD 1 to 97.1% at POD 30. At POD 30, 96.6% eyes with recorded results achieved target acuity. Mean IOP was 18.6 mmHg at POD 1 but declined to ≤15.2 mmHg thereafter. Investigators reported 22 AEs in 20 patients, all reported mild or moderate, the most common: IOP increase (7 events). Conclusion Patients undergoing cataract surgery and treated with intraocular DXM showed favorable inflammatory and visual outcomes, without unanticipated safety problems, consistent with results of previous controlled clinical trials.

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Section: Introductionmentioning

confidence: 99%

“… 13 Intraocular DXM was comparable to the topical medication in overall safety, the primary study outcome, and in ACC clearing, an exploratory effectiveness endpoint. 11 , 12…”

Section: Introductionmentioning

confidence: 99%

First Real-World, Multicenter, Post-Marketing, Retrospective Study of Dexamethasone Intraocular Suspension for Inflammation After Cataract Surgery

Bacharach¹,

McCabe²,

Jackson³

et al. 2022

OPTH

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“…Dexycu is a 9% dexamethasone suspension to be injected peri-operatively after insertion of the intraocular lens and reduces postoperative inflammation. 37 Recently, Ocular Therapeutix (Bedford, MA) brought Dextenza on the market, a 0.7 mg dexamethasone containing punctum plug to prevent postoperative inflammation. 33 Two prospective multicenter studies observed a reduction in ocular pain and inflammation compared to a placebo device.…”

Section: Discussionmentioning

confidence: 99%

Safety and Comfort of an Innovative Drug Delivery Device in Healthy Subjects

Bertens

Dunker

Dias³

et al. 2020

Trans. Vis. Sci. Tech.

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Purpose The aim of this study was to investigate safety and comfort of two versions of a placebo-microsphere filled ocular coil (straight and curved) in healthy subjects. Methods The study was a single-center intervention study. One ocular coil was placed in the inferior conjunctival fornix for the intended duration of 28 days. Forty-two healthy adult subjects were included. At baseline, 30 minutes, 8 hours, 24 hours, 48 hours, 7 days, 14 days, 21 days, and 28 days after insertion, examinations were performed, including slit lamp evaluation to score ocular redness, intraocular pressure measurement, visual acuity, tear secretion test, and questionnaires. Results The straight and curved ocular coils had a median retention time of 5 days and 12 days, respectively. After 48 hours, 57% and 81% subjects retained the straight and curved ocular coil, respectively. Four (19%) subjects with the straight coil and six (29%) with the curved coil completed the entire study period. Minor changes in ocular hyperemia were observed in both groups. On day 7, the straight coil was more comfortable than the curved coil with a visual analogue scale (VAS) score of 77 ± 21 compared to 94 ± 11 ( P = 0.028), respectively. No other ocular adverse events were observed. Conclusions Comfort and safety of the straight and curved ocular coil are high. Because the retention time is too short for long-term sustained drug release, the use in the perioperative or immediate postoperative period could prove to be more valuable. Translational Relevance The ocular coil is a noninvasive, comfortable and safe short-term drug delivery device.

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“…Although various commercial formulation of steroids and antibiotics are available for intracameral injection before the end of the surgical procedure, it is an intraocular injection and bears inherent risks such as endophthalmitis and additional injection related trauma. In addition, the volume of an intracameral injection is limited and there are high levels of steroid that might increase intraocular pressure (IOP) 6 . We hypothesized that a subconjunctivally injectable drug delivery system would be safer for the patient and release drugs more slowly with lower peak levels.…”

Section: Introductionmentioning

confidence: 99%

Single subconjunctival injection formulation using sol-gel mesoporous silica as a controlled release system for drop-free post-cataract surgery care

Sun

Huffman

Freeman

et al. 2020

J Cataract Refract Surg

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Purpose: To develop a mesoporous silica drug delivery system and target drop-free care after cataract surgery with a single subconjunctival injection. Setting: Laboratory.Design: Experimental animal study.Methods: Ketorolac was infiltration-loaded into sol-gel mesoporous silica particles encapsulated with poly(allylamine hydrochloride) and poly(sodium 4-styrenesulfonate) using a layer-by-layer adsorption technique (SG-Ket-LBL). The formulation was subjected to an in vitro and in vivo drug release study in addition to ocular toxicology evaluation.Results: Thermogravimetric analysis revealed that the drug loading efficiency was 4.4% for the SG-Ket-LBL particles. The in vivo safety study demonstrated that the formulation was well tolerated after subconjunctival injection and aqueous humor pharmacokinetics showed sustained therapeutic drug release for the targeted time window of 6 to 8 weeks. Conclusion:Findings indicated that sol-gel mesoporous silica could be used as a drug carrier for subconjunctival administration. The tested formulation, SG-Ket-LBL, provided therapeutic ketorolac for 6 to 8 weeks, which might be used for a single subconjunctival injection to replace nonsteroidal anti-inflammatory drug eyedrops after cataract surgery.

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Safety of IBI-10090 for inflammation associated with cataract surgery: Phase 3 multicenter study

Abstract: The safety and efficacy of IBI-10090 and prednisolone 1.0% were similar, with IBI-10090 preferred over drops.

Cited by 30 publications

References 18 publications

First Real-World, Multicenter, Post-Marketing, Retrospective Study of Dexamethasone Intraocular Suspension for Inflammation After Cataract Surgery

First Real-World, Multicenter, Post-Marketing, Retrospective Study of Dexamethasone Intraocular Suspension for Inflammation After Cataract Surgery

Safety and Comfort of an Innovative Drug Delivery Device in Healthy Subjects

Single subconjunctival injection formulation using sol-gel mesoporous silica as a controlled release system for drop-free post-cataract surgery care

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