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DuraSite (DuraSite)

✓ Approved

InSite Vision, Inc. · 小分子 · 小分子

什么是 DuraSite？

DuraSite 是一种小分子，由InSite Vision, Inc.研发。该药已获批，用于治疗相关适应症，给药途径：Unknown。

药物档案

商品名DuraSite
公司InSite Vision, Inc.
药物类别小分子
给药途径Unknown
状态Approved
来源： ClinicalTrials.gov, InSite Vision, Inc.

治疗适应症

DuraSite 针对 1 个适应症，涉及 1 个治疗领域。

治疗领域疾病/病症分期
Surgical and medical proceduresOral appliance application✓ Approved

相关研究文献

PubMedPharmaceutics2024-07-27

Clinical Ocular Exposure Extrapolation for a Complex Ophthalmic Suspension Using Physiologically Based Pharmacokinetic Modeling and Simulation.

Le Merdy Maxime M, Spires Jessica J, Tan Ming-Liang ML, Zhao Liang L et al.

The development of generic ophthalmic drug products with complex formulations is challenging due to the complexity of the ocular system and a lack of sensitive testing to evaluate the interplay of its physiology with ophthalmic drugs. New methods are needed to facilitate the development of ophthalmic generic drug products. Ocular physiologically based pharmacokinetic (O-PBPK) models can provide insight into drug partitioning in eye tissues that are usually not accessible and/or are challenging to sample in humans. This study aims to demonstrate the utility of an ocular PBPK model to predict human exposure following the administration of ophthalmic suspension. Besifloxacin (Bes) suspension is presented as a case study. The O-PBPK model for Bes ophthalmic suspension (Besivance® 0.6%) accounts for nasolacrimal drainage, suspended particle dissolution in the tears, ocular absorption, and distribution in the rabbit eye. A topical controlled release formulation was used to integrate the effect of Durasite® on Bes ocular retention. The model was subsequently used to predict Bes exposure after its topical administration in humans. Drug-specific parameters were used as validated for rabbits. The physiological parameters were adjusted to match human ocular physiology. Simulated human ocular pharmacokinetic profiles were compared with the observed ocular tissue concentration data to assess the OCAT models' ability to predict human ocular exposure. The O-PBPK model simulations adequately described the observed concentrations in the eye tissues following the topical administration of Bes suspension in rabbits. After adjustment of physiological parameters to represent the human eye, the extrapolation of clinical ocular exposure following a single ocular administration of Bes suspension was successful.

PMID 39065612
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PubMedInternational medical case reports journal2022-01-08

Delayed Epithelial Healing with Corneal Edema and Haze After Photorefractive Keratectomy Using Intraoperative Mitomycin C.

Moshirfar Majid M, West William B WB, Milner Dallin C DC, McCabe Shannon E SE et al.

We report an unusual presentation of presumed mitomycin C toxicity with possible subsequent hypersensitization to other medication toxicities. A 50-year-old female presented three months after photorefractive keratectomy with intraoperative mitomycin C for the management of persistent epithelial defects, corneal haze, and edema. She was found to have used an expansive and rapidly changing medical regimen which may have caused additional toxicity. These medications included besifloxacin, bromfenac, and ketotifen. Additives such as benzalkonium chloride and DuraSite® may have also contributed. Intraoperative mitomycin C can result in longstanding corneal haze, edema, and delayed epithelial healing in the setting of corneal refractive surgery. These may leave the cornea more susceptible to additional subsequent medication toxicities during the postoperative period. This report describes a case of mitomycin C exposure leading to a prolonged sensitivity to other medication toxicities, which has not been discussed elsewhere in the literature.

PMID 34992474
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PubMedExpert opinion on pharmacotherapy2019-07-26

Efficacy and safety of bromfenac 0.075% formulated in DuraSite for pain and inflammation in cataract surgery.

Wentz Scott M SM, Price Francis F, Harris Alon A, Siesky Brent B et al.

Introduction: Bromfenac is a topical ophthalmic non-steroidal anti-inflammatory drug (NSAID) used to reduce pain and treat post-operative inflammation after cataract surgery. Bromfenac 0.075% in the DuraSite™ vehicle is a newly-approved formulation which has been shown to be efficacious and safe for use in cataract surgery to reduce pain and treat inflammation. It has been shown to have a slightly better posterior segment ocular bioavailability compared to similar topical ophthalmic NSAIDs. However, there is a paucity of studies investigating its role in the prevention and treatment of post-operative pseudophakic cystoid macular edema. Areas covered: In this review, the authors provide an overview of similar products available, describe the novelty of bromfenac 0.075% in the DuraSite vehicle, and discuss the relevant clinical studies to determine if the formulation is safe and efficacious. Expert opinion: Bromfenac 0.075% in the DuraSite vehicle is a new topical ophthalmic medication which has been approved by the FDA for the prevention of pain and treatment of post-operative inflammation. It provides cataract surgeons with an additional medication for cataract surgery. However, no robust studies have been performed showing the effect that it has on the reduction or prevention of post-operative pseudophakic cystoid macular edema.

PMID 31343372
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PubMedClinical ophthalmology (Auckland, N.Z.)2018-06-01

An ex vivo human aqueous humor-concentration comparison of two commercial bromfenac formulations.

Walters Thomas R TR, Smyth-Medina Robert J RJ, Cockrum Paul C PC

The purpose of this study was to quantify the concentration of bromfenac in the aqueous humor utilizing high-performance liquid chromatography mass spectrometry between two commercial nonsteroidal anti-inflammatory drugs, using aqueous humor concentrations to characterize pharmacokinetic proportional differences between 0.075% bromfenac ophthalmic solution in DuraSite (BromSite®) and 0.09% bromfenac ophthalmic solution (Bromday®). In this multicenter, randomized, double-masked, two-arm, parallel-group, comparative, Phase II clinical trial, subjects were assigned to receive bromfenac in DuraSite or bromfenac ophthalmic solution in a 1:1 ratio. One drop of the masked test article was instilled into the study eye once a day for 2 days prior to and 3 hours prior (last instillation) to the subject's cataract surgery. Aqueous humor samples were collected upon initial cataract incision for analysis of bromfenac levels. The primary end point was aqueous humor concentration of bromfenac at Day 3, at the initiation of cataract surgery. Aqueous humor samples were collected and analyzed for bromfenac levels. A total of 60 subjects completed the study, 30 in each group. The mean bromfenac aqueous humor concentration in subjects who received bromfenac in DuraSite was more than twice (49.33±41.87 ng/mL, P=0.004) that of subjects who received bromfenac ophthalmic solution (23.65±16.31 ng/mL) after three doses. Mean bromfenac aqueous humor concentration in subjects receiving the DuraSite-containing bromfenac in DuraSite (0.075%) was significantly higher compared to subjects receiving bromfenac ophthalmic solution (0.09%) after 3 days of dosing.

PMID 29849449
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PubMedOphthalmology and therapy2018-05-16

In Vivo Pharmacokinetics of Bromfenac Ophthalmic Solution 0.075%, Bromfenac Ophthalmic Solution 0.07%, and Nepafenac/Amfenac Ophthalmic Suspension 0.3% in Rabbits.

Sheppard John D JD, Cockrum Paul C PC, Justice Angela A, Jasek Mark C MC

Little is known of the ocular distribution characteristics of currently branded non-steroidal anti-inflammatory drugs (NSAIDs) in the United States. This study was designed to predict the ocular bioavailability characteristics in humans using Dutch Belted rabbits as a surrogate. Commercially available, topically-applied NSAIDs containing bromfenac or nepafenac/amfenac were evaluated. 126 healthy adult Dutch Belted rabbits were randomly assigned to three treatment cohorts (BromSite® twice daily [BID] in the right eye, BromSite® once daily [QD] in the right eye, Prolensa® QD in the right eye and Ilevro™ QD in the left eye) and 7 post-dosing time points (0.5, 1, 2, 4, 8, 12, 24 h after final instillation). The study eyes received 40 µL of the assigned drug for a consecutive 9 days. Samples of aqueous humor, iris-ciliary body, choroid, sclera, and retina were harvested from the study eyes at the assigned time point after the last dose on the 9th day. NSAID content in ocular tissues was analyzed using high-performance liquid chromatography (HPLC), and area under the curve (AUC0.5-24h), maximum concentration (Cmax), and time to maximum concentration (Tmax) were determined. Peak NSAID concentrations were reached within 1-3 h in the anterior segment and within 1-3 h in the posterior segment after last dose. Throughout the ocular tissues, both AUC and Cmax for BromSite® (BID and QD) were consistently higher than respective NSAID concentrations of Prolensa® QD and Ilevro® QD. When comparing BromSite® BID to QD, the BID regimen produced generally higher but statistically similar bromfenac concentrations throughout the ocular tissues except in the aqueous humor and iris-ciliary body, where the AUC BID was statistically significantly higher with BromSite® BID. As a surrogate to human ocular bioavailability, BromSite® demonstrated significantly greater NSAID compared to Prolensa® QD and Ilevro® QD. The DuraSite® component of BromSite® appears to enhance ocular penetration throughout both anterior and posterior tissues. Sun Pharmaceutical Industries Ltd.

PMID 29761367
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PubMedOphthalmology and therapy2017-08-19

Twice-Daily vs. Once-Daily Dosing with 0.075% Bromfenac in DuraSite: Outcomes from a 14-Day Phase 2 Study.

Trattler William W, Hosseini Kamran K

Bromfenac is a well-known topical ophthalmic nonsteroidal anti-inflammatory drug (NSAID) that is commercialized in the USA and other regions of the world. A new formulation, 0.075% bromfenac in DuraSite®, was developed to treat postoperative inflammation and reduce pain in patients who have undergone cataract surgery. We hypothesized that efficacy and safety would be enhanced with twice-daily (BID) dosing compared to once-daily (QD) dosing. This was a multicenter, double-masked, comparative study in which 40 and 45 subjects were randomized to groups receiving BID dosing and QD dosing, respectively. Subjects self-instilled the study drug for 14 days postoperative and were followed for an additional 2-week evaluation phase. The primary efficacy endpoint was the proportion of subjects with an anterior chamber cell (ACC) grade of 0 at day 15. A total of 45 subjects had cleared ACC (grade "0") at day 15, of whom 21 were in the BID group (52.5%) and 24 were in the QD group (53.5%). A secondary analysis found 7/40 (17.5%) subjects in the BID group and 10/45 (22.2%) subjects in the QD group achieved an ACC grade of 0 at day 8. There were more adverse events in the QD group (n = 16) than in the BID group (n = 12). Similar outcomes were observed for subjects using Bromfenac 0.075% in DuraSite® in the BID and QD dosing regimens for the treatment of post-cataract surgery inflammation. ClinicalTrials.gov identifier, NCT01190878. InSite Vision (now a division of Sun Pharma).

PMID 28819932
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