Sustained Ocular Delivery of Fluocinolone Acetonide by an Intravitreal Insert

Campochiaro, Peter A.; Hafiz, Gulnar; Shah, Syed Mahmood; Bloom, Steven M.; Brown, David M.; Busquets, Miguel; Ciulla, Thomas A.; Feiner, Leonard; Sabates, Nelson R.; Billman, Kathleen; Kapik, Barry; Green, Ken; Kane, Frances

doi:10.1016/j.ophtha.2009.11.024

Cited by 148 publications

(108 citation statements)

References 18 publications

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“…Iluvien ® is made of polyimide and PVA, small enough to be injected using an inserter with a 25-gauge needle and is expected to provide sustained delivery of FA to the back of the eye for up to three years [119]. Alimera Sciences is currently conducting two Phase III pivotal clinical trials (FAME Study) for Iluvien ® involving 956 patients in sites across the United States, Canada, Europe and India to assess the efficacy and safety of Iluvien ® with high (0.45 g/day) and low (0.23 g/day) doses [120]. The primary efficacy endpoint for the FAME Study is the difference in the percentage of patients whose best corrected visual acuity (BCVA) improved by 15 or more letters from baseline on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart, at 24 months, between the treatment and control groups.…”

Section: Durasert™ Technology Systemmentioning

confidence: 99%

Recent Advances in Ocular Drug Delivery Systems

2011

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Abstract:Transport of drugs applied by traditional dosage forms is restricted to the eye, and therapeutic drug concentrations in the target tissues are not maintained for a long duration since the eyes are protected by a unique anatomy and physiology. For the treatment of the anterior segment of the eye, various droppable products to prolong the retention time on the ocular surface have been introduced in the market. On the other hand, direct intravitreal implants, using biodegradable or non-biodegradable polymer technology, have been widely investigated for the treatment of chronic vitreoretinal diseases. There is urgent need to develop ocular drug delivery systems which provide controlled release for the treatment of chronic diseases, and increase patient's and doctor's convenience to reduce the dosing frequency and invasive treatment. In this article, progress of ocular drug delivery systems under clinical trials and in late experimental stage is reviewed.

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Section: Durasert™ Technology Systemmentioning

confidence: 99%

Recent Advances in Ocular Drug Delivery Systems

2011

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“…The ocular concentration of drug for both concentrations peaks at 1 week and remains at that level for 2 months prior to declining to a steady state level for at least 12 months [109]. Two randomized, prospective, sham injection controlled trials (FAME) evaluating the efficacy and safety of the 0.2 and 0.5 lg FA inserts found both doses to meet the primary study endpoint with 28 % of patients achieving a greater than 15 letter gain in visual acuity compared to 16 % in the sham group [110].…”

Section: Fluocinolone Acetonidementioning

confidence: 98%

“…The Iluvien FA insert releases 0.2 or 0.5 lg of FA over the three-year lifespan of the insert [109] and is injected via a modified needle system similar to IVTA. The ocular concentration of drug for both concentrations peaks at 1 week and remains at that level for 2 months prior to declining to a steady state level for at least 12 months [109].…”

Section: Fluocinolone Acetonidementioning

confidence: 99%

Corticosteroids for the Treatment of Diabetic Macular Edema

Sharma

Mruthyunjaya

2014

Curr Ophthalmol Rep

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Diabetic macular edema (DME) is a leading cause of vision loss throughout the world. Three different corticosteroids have been used in the treatment of diabetic macular edema: triamcinolone acetonide, dexamethasone, and fluocinolone acetonide. Intravitreal injection of all three corticosteroids is associated with a similar side effect profile including worsening/formation of cataract, elevation of intraocular pressure, pseudo-endophthalmitis, and infectious endophthalmitis. Sustained-release implants of corticosteroids have recently been studied, and one has recently received FDA approval as the first corticosteroid for the treatment of diabetic macular edema. This review will address some of the major studies evaluating corticosteroids for DME and will focus on studies published within the last 2 years.

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“…177 On the other hand, the superficial anatomic location, clear optical media for direct visualization and multiple compartments for drug retaining represent advantages of local drug delivery for this special organ. 178 However, like those newer biologic agents discussed in the previous section, this treatment modality is now under intense investigation with insufficient evidences to quality its general clinical applicability in the current stage. A recent review has dedicated itself to local treatment of ocular inflammatory disease, so in the current review, only a few comments on this novel treatment modality in uveitis are delivered.…”

Section: Local Treatmentsmentioning

confidence: 99%

Immunosuppressive Treatment of Non-infectious Uveitis: History and Current Choices

Zhao¹,

Zhang²

2017

cmsj

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Non-infectious uveitis is one of the leading causes of preventable blindness worldwide. Long-term immunosuppressive treatment is generally required to achieve durable control of inflammation in posterior and panuveitis. Although systemic corticosteroids have been the gold standard of immunosuppressive treatment for uveitis since first introduced in 1950s, its side effects of long-term use often warrant an adjuvant treatment to reduce the dosage/duration of corticosteroids needed to maintain disease control. Conventional immunosuppressive drugs, classified into alkylating agent, antimetabolites and T cell inhibitors, have been widely used as corticosteroid-sparing agents, each with characteristic safety/tolerance profiles on different uveitis entities. Recently, biologic agents, which target specific molecules in immunopathogenesis of uveitis, have gained great interest as alternative treatments for refractory uveitis based on their favorable safety and effectiveness in a variety of uveitis entities. However, lack of large randomized controlled clinical trials, concerns about efficacy and safety of long-term usage, and economic burden are limiting the use of biologics in non-infectious uveitis. Local administration of immunosuppressive drugs (from corticosteroids to biologics) through intraocular drug delivery systems represent another direction for drug development and is now under intense investigation, but more evidences are needed to support their use as regular alternative treatments for uveitis. With the numerous choices belonging to different treatment modalities (conventional immunosuppressive agents, biologics and local drug delivery systems) on hand, the practice patterns have been reported to vary greatly from center to center. Factors influence uveitis specialists' choices of immunosuppressive agents may be complex and may include personal familiarity, treatment availability, safety/tolerability, effectiveness, patient compliance, cost concerns and suggestions from related specialists such as rheumatologists and pediatricians. The focus of this review is to provide an overview of each treatment modality on safety/tolerability and effectiveness, which are believed to be the two most important factors affecting treatment decision making.

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Sustained Ocular Delivery of Fluocinolone Acetonide by an Intravitreal Insert

Cited by 148 publications

References 18 publications

Recent Advances in Ocular Drug Delivery Systems

Recent Advances in Ocular Drug Delivery Systems

Corticosteroids for the Treatment of Diabetic Macular Edema

Immunosuppressive Treatment of Non-infectious Uveitis: History and Current Choices

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