Safety and efficacy of a dexamethasone anterior segment drug delivery system in patients after phacoemulsification

Wadood, Azfar C; Armbrecht, Ana Maria; Aspinall, Peter; Dhillon, Baljean

doi:10.1016/j.jcrs.2003.08.028

Cited by 68 publications

(34 citation statements)

References 15 publications

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“…12 Surodex (Oculex Pharmaceuticals, Inc., Sunnyvale, CA), a dexamethasone anterior segment drug delivery system, has been proven to be effective to treat inflammation after cataract surgery. 13 Even though satisfactory anti-inflammatory results were achieved, adverse side effects, such as implant migration in anterior chamber or peripheral anterior synechiae, have been reported.…”

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confidence: 99%

Optimization of Subconjunctival Biodegradable Microfilms for Sustained Drug Delivery to the Anterior Segment in a Small Animal Model

Liu

Peng

Lwin

et al. 2013

Invest. Ophthalmol. Vis. Sci.

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Citation: Liu YC, Peng Y, Lwin NC, Wong TT, Venkatraman SS, Mehta JS. Optimization of subconjunctival biodegradable microfilms for sustained drug delivery to the anterior segment in a small animal model. Invest Ophthalmol Vis Sci. 2013;54:260754: -261554: . DOI: 10.1167 PURPOSE. We evaluated a biodegradable, sustained-release, prednisolone acetate (PA)-loaded poly[d,l-lactide-co-e-caprolactone] (PLC) drug delivery system on its biocompatibility, feasibility and release characteristics in vitro and in vivo.METHODS. Blank and 40% PA-loaded PLC microfilms with a diameter of 2 mm were fabricated, and the degradation and drug release profiles of the microfilms were characterized in vitro and in vivo. The microfilms were implanted into the subconjunctival space of Lewis rats (n ¼ 48). All eyes were assessed clinically using slit-lamp biomicroscopy, and graded with HackettMcDonald ocular scoring system and anterior segment optical coherence tomography. Histologic and immunohistochemical analyses were performed comparing blank and PAloaded microfilm groups. PA concentrations in the aqueous humor were determined by HPLC.RESULTS. Subconjunctivally-implanted PLC microfilms were able to deliver PA in a sustained manner over 3 months, with a steady rate of 0.002 mg/d in vivo. Eyes with either blank or PAloaded implanted microfilms showed a very minimal inflammatory response at the insertion sites and mild degree of collagen encapsulation around the microfilms, with significantly less CD11c cells at 2 and 4 weeks (P ¼ 0.001 and P ¼ 0.002), and collagen formation at 2 weeks (P ¼ 0.001) in the PA-loaded microfilm group. Anterior chamber PA levels were achieved, with concentrations at 76.7 6 5.9, 70.3 6 2.3, and 42.7 6 4.1 ng/mL at 2, 4, and 12 weeks, respectively.CONCLUSIONS. PA-loaded PLC microfilms display good biocompatibility, feasibility, and desirable sustained drug release profiles, and have the potential to exhibit antifibrotic and antiinflammatory effects. This device is applicable to use in small animal models of anterior segment inflammation.

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mentioning

confidence: 99%

Optimization of Subconjunctival Biodegradable Microfilms for Sustained Drug Delivery to the Anterior Segment in a Small Animal Model

Liu

Peng

Lwin

et al. 2013

Invest. Ophthalmol. Vis. Sci.

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“…Approximately 1.0 and 0.4 µg/ml of dexamethasone were released into the aqueous humor and vitreous, respectively, after 6 days. These concentrations are higher than those reported in other studies, in which dexamethasone delivery devices were implanted into the anterior chamber after cataract surgery [9, 10, 16]. As the DDS retrieved from the implanted lenses did not demonstrate significant degradation signals (fig.…”

Section: Discussionmentioning

confidence: 60%

“…Surodex®, a dexamethasone anterior segment DDS (Oculex Pharmaceuticals Inc., USA), was developed to address the difficulties associated with topical corticosteroids to treat inflammation after cataract surgery and has proved to be effective [9, 10]. However, as the device is not sutured into place, adverse events like peripheral anterior synechiae and migration of the implant to the interface between the posterior convexity of the IOL and the posterior capsule may occur [16]. Furthermore, it can also present difficulty if removal is necessary.…”

Section: Discussionmentioning

confidence: 99%

Pharmacokinetic and Toxicity Investigations of a New Intraocular Lens with a Dexamethasone Drug Delivery System: A Pilot Study

Siqueira¹,

Filho

Fialho

et al. 2006

Ophthalmologica

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Aim: To investigate the short-term safety and pharmacokinetic behavior of a new intraocular lens containing a dexamethasone drug delivery system (IOL-DDS) in rabbit eyes. Methods: A modified polymethylmethacrylate IOL containing a biodegradable dexamethasone DDS was implanted into the posterior chamber of the right eyes of 9 New Zealand white rabbits. Serial slitlamp and indirect ophthalmoscopic examinations (including grading of intraocular inflammation) were performed. After 3, 6 and 9 days, the rabbits were euthanized and the globes were removed for histological examination and for determination of dexamethasone levels in the aqueous humor and in the vitreous. Analysis of dexamethasone concentrations was performed by ELISA. Results: Therapeutic concentrations of dexamethasone were detectable in the aqueous and vitreous of the study eyes throughout the 9-day period in all tested animals. The mean aqueous dexamethasone concentration (ng/ml, ±SD) was 1,015.42 (±43.05), 970.11 (±32.47) and 757.58 (±30.19) and the mean vitreous concentration (ng/ml, ±SD) was 399.82 (±38.05), 287.38 (±34.47) and 268.15 (±32.00) at 3, 6 and 9 days after the surgical procedure, respectively. No corneal or retinal histological changes were observed during the study period. Conclusion: The IOL-DDS is effective in delivering therapeutic concentrations of dexamethasone to the aqueous and vitreous, without acute damage to the cornea and retina. Further controlled studies in the same animal model are under way to determine the potential value of this lens in the prevention and treatment of inflammation following cataract surgery.

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“…Theoretically, TA crystals should be removed as much as possible at the end of surgery, because steroid granules left in the anterior chamber might induce secondary glaucoma or infection. But, it might not be necessary because an intracameral depot to release dexamethasone is left safely in the anterior chamber after cataract surgery [26]. In addition, it is impossible in practice to remove all the granules from the anterior chamber.…”

Section: Triamcinolone Acetonide and Other Related Materialsmentioning

confidence: 99%

Chromovitrectomy in Vitreous Loss During Cataract Surgery

Sakamoto¹,

Hisatomi²

2013

Cataract Surgery

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Safety and efficacy of a dexamethasone anterior segment drug delivery system in patients after phacoemulsification

Abstract: Surodex appeared to be as effective as dexamethasone 0.1% eyedrops in controlling intraocular inflammation after cataract surgery by phacoemulsification, and both methods had a similar safety profile.

Cited by 68 publications

References 15 publications

Optimization of Subconjunctival Biodegradable Microfilms for Sustained Drug Delivery to the Anterior Segment in a Small Animal Model

Optimization of Subconjunctival Biodegradable Microfilms for Sustained Drug Delivery to the Anterior Segment in a Small Animal Model

Pharmacokinetic and Toxicity Investigations of a New Intraocular Lens with a Dexamethasone Drug Delivery System: A Pilot Study

Chromovitrectomy in Vitreous Loss During Cataract Surgery

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