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At least 19 recordsLinked to original sources
PubMed2005

Fluocinolone acetonide ophthalmic--Bausch & Lomb: fluocinolone acetonide Envision TD implant.

Bausch & Lomb and Control Delivery Systems have developed an intravitreal implant that can deliver the corticosteroid fluocinolone acetonide [fluocinolone acetonide implant, Retisert] to posterior eye tissue for up to 3 years. The implant uses Bausch & Lomb's Envision TD technology. This fluocinolone acetonide implant has been designed for the treatment of non-infectious uveitis affecting the posterior segment of the eye and other eye disorders, which benefit from local anti-inflammatory therapy. In July 2003, Bausch & Lomb assumed all responsibility for day-to-day clinical development and regulatory activities relating to fluocinolone acetonide implant development from Control Delivery Systems. In May 2002, Control Delivery systems and Bausch & Lomb formally amended their budget for their license and development agreement. Bausch & Lomb will increase its funding to support the development of agents for the treatment of diabetic macular oedema, posterior uveitis and wet age-related macular degeneration to USD $206 million through to 2008. In January 2004, Bausch & Lomb decided to focus development of the fluocinolone acetonide implant in only one indication, non-infectious uveitis affecting the posterior segment of the eye. It had been in development for other indications, including macular oedema and age-related macular degeneration. However, these will be targeted with later-generation implant technologies, different drugs, or combinations of both. The implant delivering fluocinolone acetonide 0.59 mg or 2.1mg has completed enrollment in two pivotal 3-year phase IIb/III trials in the US, Canada, Australia and Asia for the treatment of posterior uveitis. Enrollment in these multicenter randomised, double-masked studies was closed in May 2003. Bausch & Lomb was expected to file an NDA with the US FDA for the use of the agent in the treatment of uveitis in mid-2003. However, in February 2003, the company reported that, after a review of various filing strategies, the date of filing for the treatment of non-infectious uveitis affecting the posterior segment of the eye would be held back until mid-2004, with possible commercialisation during 2005. Positive results based on 34-week data from the first phase III trial of fluocinolone acetonide implant, conducted in 26 US centres and one centre in Singapore, were reported in September 2003. Patients in this trial will be followed for an additional 2.5 years. Thirty-four-week results from the second phase III trial, conducted in 239 patients at 19 centres in Canada, the US, Australia, India, the Philippines and Hong Kong, have confirmed results in the initial phase III study, and were presented at the 37th Annual Meeting of the Retina Society. Bausch & Lomb continues to target commercialisation for 2005. In May 2000, the fluocinolone acetonide implant was granted fast-track status from the FDA and in July 2000 it received Orphan Drug designation from the FDA for posterior uveitis. In addition, enrollment was completed in a phase II trial of a fluocinolone acetonide 0.59 mg implant for the treatment of predominantly occult subfoveal choroidal neovascularisation in patients with AMD in July 2002. However, development in this indication has been discontinued.

Anti-Inflammatory Agents↗
PubMed2000

Efficacy of fluocinolone acetonide gel in the treatment of oral lichen planus.

OBJECTIVE: The purpose of this study was to compare the efficacy of fluocinolone acetonide gel 0.1% in 2 base forms (numbers 1 and 2) with fluocinolone acetonide in an oral base 0.1%. STUDY DESIGN: Forty-eight patients with histologically confirmed oral lichen planus were enrolled in the study. Lesions were scored ranging from 0 (no lesion) to 5 (large erosion) according to the severity. Patients were randomly given fluocinolone acetonide in an oral base, fluocinolone acetonide gel no. 1 or no. 2. They were asked to apply the medication on dried lesions 4 times a day. The lesions were evaluated after 2 and 4 weeks of treatment. The severity scores were analyzed by the Kruskal-Wallis k-sample test. RESULTS: Patients who received fluocinolone acetonide in an oral base and those who received fluocinolone acetonide gel no. 1 and no. 2 improved from the average score of 3.0, 3.0, and 2.9 to 1.5, 1.5, and 1.6, respectively. There were no statistically significant differences in score changes noted in the 3 groups. The results indicate that fluocinolone acetonide gel no. 1 and no. 2 and fluocinolone acetonide in an oral base provide similar efficacy in the treatment of oral lichen planus. CONCLUSION: Fluocinolone acetonide gel 0.1% is a safe and effective alternative therapy to fluocinolone acetonide in an oral base 0.1% in the treatment of oral lichen planus.

Administration, Topical↗
PubMed1999

[Fluocinolone Acetonide Reference Standard (Control 981) of National Institute of Health Sciences].

The raw material of fluocinolone acetonide was examined for preparation of the "Fluocinolone Acetonide Reference Standard (Control 981)". The analytical data obtained were: melting point, 271.5 degree C; UV spectrum, Lambda max of 237.0 nm and specific absorbance in ethanol at 237 nm of 359.3; IR spectrum, same as that of the Fluocinolone Acetonide Reference Standard (Control 904); optical rotation, [alpha]20(D) = + 102.8; thin-layer chromatography, no impurities detected; high-performance liquid chromatography, one impurity detected and total amount estimated to be about 0.17%; loss on drying, 0.29%; assay by HPLC, 100.9%. Based on the above results, the raw material was authorized as the Fluocinolone Acetonide Reference Standard (Control 981) of the National Institute of Health Sciences.

Fluocinolone Acetonide↗
PubMed1995

Chemical stability of fluocinolone acetonide ointment and fluocinonide cream diluted in emollient bases.

The chemical stability of fluocinolone acetonide ointment and fluocinonide cream was studied when diluted in emollient bases. Fluocinolone acetonide ointment was diluted 1 in 4 with Unguentum Merck and Lipobase. Fluocinonide cream was also studied in these bases, with the addition of Metosyn Diluent, at dilutions of 1 in 4 and 1 in 10. Regression analysis gave the time for 5% degradation of fluocinolone acetonide at a dilution of 1 in 4 in Unguentum Merck and in Lipobase as 12 weeks in both cases. The lower 95% confidence bound of each regression line was used to set shelf lives, for additional safety, and gave values of 1 month for the Unguentum Merck dilution and 2 months for the Lipobase dilution. Fluocinonide dilutions were more stable than the corresponding fluocinolone acetonide dilutions, with no degradation detectable during the study. The base made no observable difference to stability. Shelf lives, based on the lower 95% confidence bound of the regression data, of more than 6 months would be feasible for all of the fluocinonide 1 in 4 dilutions studied and for the 1 in 10 dilution in Unguentum Merck. However, for fluocinonide 1 in 10 in Metosyn Diluent, a shelf life of only 6 weeks could be assured, due to there being more variation in the analytical results. There were insufficient data to determine a storage life based on the lower 95% confidence bound of the regression for fluocinonide 1 in 10 in Lipobase. More data would be required to determine if there was significant interbatch variation in the stability of the dilutions.

Administration, Topical↗
PubMed2000

Safety and pharmacokinetics of an intraocular fluocinolone acetonide sustained delivery device.

PURPOSE: To determine the safety and pharmacokinetics of an intraocular fluocinolone acetonide sustained drug delivery device. METHODS: Nonbiodegradable drug delivery devices containing 2 or 15 mg of a synthetic corticosteroid, fluocinolone acetonide, were constructed. The long-term in vitro release rates of these devices were determined in protein-free buffer or buffer containing 50% plasma protein. Fifteen-milligram devices were also implanted into the vitreous cavities of rabbit eyes. Intravitreal drug levels, the amount of drug remaining in explanted devices, and the release rate of explanted devices were determined over a 1-year time period. Drug toxicity was assessed over this same time period by slit lamp examination, indirect ophthalmoscopy, electroretinography, and histologic examination. RESULTS: The drug release rates for the 2-mg device, 1.9 +/- 0.25 microg/d, and for the 15-mg device, 2.2 +/- 0.6 microg/d, remained linear over the 6-month and 45-day testing period, respectively. The release rate increased by approximately 20% when devices were transferred from protein-free buffer to buffer that contained protein (P: < 0.0001). Vitreous levels remained fairly constant (0.10-0.21 microg/ml) over a 1-year period. No drug was present in the aqueous humor during this time period. Based on the device release rates, the predicted life span of the 2- and 15-mg devices are 2.7 and 18.6 years, respectively. There was no evidence of drug toxicity by clinical examination, electroretinography, or histologic examination. CONCLUSIONS: It is feasible to construct a nontoxic fluocinolone acetonide drug delivery device that reproducibly releases fluocinolone acetonide in a linear manner over an extended period. These devices show great promise in the treatment of ocular diseases such as uveitis, which are often managed with chronic corticosteroid therapy.

Animals↗
PubMed1997

Solid-state investigation of fluocinolone acetonide.

Three crystalline modifications of fluocinolone acetonide, A, B and C, were characterized by means of FTIR, DSC, TG-FTIR, MICRO-FTIR and X-ray diffractometry. They were easily differentiated by their IR absorption bands in the 3600-3400 cm-1 range. The thermal behavior was also elucidated using combined techniques; thermomicroscopy and thermogravimetry coupled with Fourier transform infrared spectroscopy were found to be very useful tools for a better understanding of thermal events. On heating, form A and C were fully converted into form B. Polymorph A was found to be enantiotropically related to B, while form C was monotropically related to B. The existence of three polymorphs was confirmed by means of their different X-ray diffraction patterns. Detailed methods of preparation of the three modifications are also described.

Administration, Topical↗
PubMed2005

Long-term follow-up results of a pilot trial of a fluocinolone acetonide implant to treat posterior uveitis.

PURPOSE: To investigate the safety and efficacy of a fluocinolone acetonide intravitreal implant in the treatment of noninfectious posterior uveitis. DESIGN: Noncomparative interventional case series, dose randomized, dose masked, prospective. PARTICIPANTS: Thirty-six eyes of 32 patients with a history of recurrent noninfectious posterior uveitis. METHODS: Patients were randomized to receive either a 0.59-mg or a 2.1-mg fluocinolone acetonide intravitreal implant. Patients were observed every 4 to 6 weeks for the first 3 months and then every 3 months thereafter. MAIN OUTCOME MEASURES: Preoperative and postoperative ocular inflammation, visual acuity (VA), antiinflammatory medication use, and safety. RESULTS: Mean follow-up duration was 683+/-461 days (range, 204-1817). Mean baseline visual acuity for the device-implanted eyes was +1.1 logarithm of the minimum angle of resolution (logMAR) units (20/250), which improved significantly to +0.81 logMAR units (20/125) at 30 months (P<0.05). Inflammation was effectively controlled over the follow-up period. The average number of recurrences in the 12 months before implantation was 2.5 episodes per eye. None of these eyes experienced a recurrence for the first 2 years after implantation. There was a reduction in systemic and local therapy use in the device-implanted eyes; of the patients who remained on systemic medication after implantation, dosage was reduced in 68%. The posterior sub-Tenon's capsule injection rate significantly decreased from a mean of 2.2 injections per eye per year to 0.07 injections per eye per year (P<0.0001) The most common adverse event was intraocular pressure (IOP) rise. At baseline, 11.0% of eyes used pressure-lowering agents, versus 56.1% over the follow-up period (P = 0.005). Filtering procedures were performed in 7 (19.4%) eyes. Four of the 8 phakic eyes, each of which had some level of cataract at device implantation, subsequently underwent cataract extraction. There were no device explantations or patients lost to follow-up during the investigation. CONCLUSION: The fluocinolone acetonide intravitreal implant effectively controlled intraocular inflammation in the studied population. Elevated IOP and cataracts that occurred in fluocinolone device-implanted eyes were managed by standard means. The fluocinolone acetonide sustained drug delivery implant seems to be promising in patients with posterior uveitis who do not respond to or are intolerant to conventional treatment.

Adolescent↗
PubMed1991

Pharmacokinetics of fluocinolone acetonide in patch versus cream formulations.

The pharmacokinetics of the fluocinolone acetonide patch containing 8 mcg/cm2 and a 0.025% cream were studied in a cross-over trial in 12 healthy volunteers 6 male and 6 female mean age 24.9 years. Each subject was treated with 0.8 mg of both fluocinolone acetonide formulations for 12 h on non-consecutive days. The high performance liquid chromatography method was used to determine the plasma and urine levels of the drug. Minor fluctuations in the plasma profile after patch application were observed, even if no significant difference was found between the two formulations with regard to peak plasma concentration, time to reach peak levels, area under the concentration curve and half-life.

Administration, Topical↗
PubMed1997

Efficacy of topical retinoic acid compared with topical fluocinolone acetonide in the treatment of oral lichen planus.

The purpose of this study was to compare the efficacy of retinoic acid in an oral base 0.05% with fluocinolone acetonide in an oral base 0.1% in the treatment of atrophic and erosive oral lichen planus. Thirty-three patients with histologically proven oral lichen planus were asked to participate in the study. Lesions were scored ranging from 0 (no lesion) to 5 (large erosion) according to the severity. Patients were randomly assigned to receive either topical fluocinolone acetonide or topical retinoic acid. They were instructed to apply the medication on dried lesions four times a day. The lesions were evaluated after 2 and 4 weeks of treatment. The sign scores were analyzed by the Wilcoxon rank sum test. Eighteen patients receiving topical fluocinolone acetonide improved from the average score of 3.0 to 1.5 after 4 weeks of treatment, whereas 15 patients receiving topical retinoic acid showed little change (average score, 2.9 and 2.4, respectively). The changes were statistically significantly different between the two groups (p = 0.01). The results suggest that 0.1% fluocinolone acetonide reduced the severity of atrophic and erosive oral lichen planus better than 0.05% retinoic acid.

Administration, Oral↗
PubMed1991

[Fluocinolone Acetonide Reference Standard (Control 901) of the National Institute of Hygienic Sciences)].

Fluocinolone Acetonide Reference Standard (Control 901) for the Japanese Pharmacopoeia (JP RS) was prepared. The following analytical data were obtained: melting point 268 degrees C (decomposition); IR spectrum was same as the previous JP RS of Fluocinolone Acetonide; absorptivity at 237nm E1%1lcm = 363; optical rotation [alpha]20D = 105.7 degrees; no impurity was detected by TLC, but two impurities were detected by HPLC analysis; assay by HPLC against the previous JP RS 100.2%. Based on the above results, this raw material was authorized as the Reference Standard of the National Institute of Hygienic Sciences.

Chromatography, High Pressure Liquid↗
PubMed1963

Clinical studies with topical fluocinolone acetonide in the treatment of various dermatoses.

Fluocinolone acetonide cream is a new, potent topical corticosteroid. When used in conjunction with an occlusive plastic film dressing, herein described, it is highly effective in the treatment of psoriasis of the glabrous skin, pustular and paronychial psoriasis, neurodermatitis, and lichen planus. Psoriasis of the intertriginous areas responds to the local use of the fluocinolone cream alone. Relapses on cessation of treatment respond as a rule to retreatment.Indications, limitations, reactions and contraindications to this form of treatment are discussed.

Adrenal Cortex Hormones↗
PubMed1997

Effect of percutaneous absorption of fluocinolone acetonide on the activity of superoxide dismutase and total antioxidant status in patients with psoriasis.

This study defines a modification of antioxidant systems by percutaneous absorption of fluocinolone acetonide. Total antioxidant status (TAS) provides an overall indication of antioxidant status. Superoxide dismutase (SOD), a primary antioxidant, accelerates the dismutation of the toxic superoxide radical produced during the oxidative energy processes into the less harmful molecules, hydrogen peroxide and molecular oxygen. We monitored the level of SOD and TAS in 7 males with psoriasis and 6 control subjects before and after a single application of fluocinolone acetonide 0.025% ointment to 90% of the body. The results showed that the plasma level of TAS was significantly increased (p < 0.02) at 24 h posttreatment. The erythrocytic level of SOD was significantly decreased (p < 0.01) only at 12 h after glucocorticosteroid application. The level of TAS and SOD in patients with psoriasis was also significantly increased (p < 0.01 for both situations) as compared to healthy controls. Our study suggests that fluocinolone acetonide as a therapeutic agent may play a role in the oxidative stress in skin diseases.

Administration, Cutaneous↗
PubMed2003

Clinical evaluation in treatment of oral lichen planus with topical fluocinolone acetonide: a 2-year follow-up.

BACKGROUND: Oral lichen planus (OLP) is a chronic inflammatory disease which is recalcitrant to medical treatment. The purpose of this study was to compare the effectiveness of various forms of the topical steroid fluocinolone acetonide applications in patients with OLP. METHODS: Data of OLP patients were collected retrospectively from the chart record and the 97 OLP patients were divided into three groups. The first group (n = 28) was treated with a 0.1% solution of fluocinolone acetonide (FAS), the second group (n = 22) with 0.1% fluocinolone acetonide in orabase (FAO), and the third group (n = 47) with both FAS and FAO (FAS/FAO) throughout the study. Each group was clinically evaluated as complete remission (CR), partial remission (PR), or no response (NR), following the treatment. Also, the side-effect of oral candidiasis was recorded in each group. RESULTS: Two years of treatment resulted in complete remission of 77.3, 21.4, and 17.0% of patients in the FAO, FAS, and FAS/FAO groups, respectively. There was a statistically significant difference in disease remission (P < 0.05), but not in oral candidiasis appearance (P > 0.05) among various forms of topical steroid application. CONCLUSION: The study concluded that FAO or FAS can produce improved results in the management of OLP by long-term follow-up.

Administration, Topical↗
PubMed1961

A new corticoid for topical therapy. Fluocinolone acetonide.

Sixty-seven patients with chronic and subacute cutaneous lesions of varying long duration that had previously been resistant to topical use of corticosteroid compounds were treated with a cream containing fluocinolone acetonide. To avoid subjective bias, only two classifications were used in appraising results: "complete clearing of treated lesions" and "not effective."Forty-eight patients had complete clearing of the treated area. Results were best in atopic dermatitis, chronic eczematous dermatitis and nummular dermatitis. Granuloma annulare, dyshidrotic dermatitis of the palms and psoriasis were not affected. In some cases in which there were multiple lesions some of the lesions were treated with fluocinolone acetonide cream and some were treated concurrently with other corticoid ointments or with noncorticoid compounds, either bland or with active ingredients. Fluocinolone was effective in more than twice as many cases as the other agents. In some of the patients with chronic disease it was possible to greatly reduce or discontinue systemic steroid therapy after fluocinolone acetonide became available. No untoward effects were observed.

Administration, Topical↗
PubMed2000

Fluocinolone acetonide sustained drug delivery device to treat severe uveitis.

PURPOSE: Uveitis is often a chronic disease requiring long-term medical therapy. In this report, we describe a pilot safety and efficacy trial of a novel sustained drug delivery system containing fluocinolone acetonide to treat patients with severe uveitis. DESIGN: Prospective, noncomparative, interventional case series PARTICIPANTS: Patients with severe uveitis. METHODS: Sustained drug delivery devices designed to release fluocinolone acetonide for at least 2.5 years were implanted through the pars plana into the vitreous cavity of seven eyes of five patients. All patients had severe uveitis not well controlled with, or intolerant to, repeated periocular corticosteroid injections, systemic corticosteroids, nonsteroidal immunosuppressive agents, or a combination thereof at the time of device implantation. Before device implantation, patients underwent complete evaluation including history, ophthalmologic examination, fluorescein angiography, visual field testing, and electroretinography. After surgery, patients were reexamined at 1 week, 2 weeks, 4 weeks, and at 1- to 3-month intervals. Visual fields, electroretinograms, and fluorescein angiography were repeated at 3- to 6-month intervals. MAIN OUTCOME MEASURES: Preoperative and postoperative visual acuity, ocular inflammation, anti-inflammatory medication use, and intraocular pressure. RESULTS: Patients had a diagnosis of Behçet's syndrome (two eyes), or idiopathic panuveitis (five eyes, including two with necrotizing retinitis, two with progressive chorioretinitis, and one with iridocyclitis and intermediate uveitis). Patients were observed an average of 10 months (range, 5-19 months). All eyes had stabilized or improved visual acuity after device implantation, and four of seven eyes had an improvement of three lines or more. The mean initial visual acuity, measured by Snellen chart, was 20/207, and the mean final visual acuity was 20/57 (P = 0.02). After surgery, at the final visit, no eye had clinically detectable inflammation, and all seven eyes had a marked reduction in systemic, topical, and periocular anti-inflammatory medication use. Four eyes had increased intraocular pressure 6 weeks to 6 months after device implantation. Intraocular pressure has been controlled on topical medications. No patient experienced intraoperative complications. CONCLUSIONS: A fluocinolone acetonide sustained drug delivery device is a promising new therapy for the treatment of severe uveitis. Intraocular pressure must be carefully monitored long after device implantation. Based on these data, a randomized study of a larger group of patients is warranted.

Adolescent↗