- |||||||||| Iluvien (fluocinolone acetonide) / Alimera Sci, EyePoint Pharma
[VIRTUAL] ILUVIEN® implant in eyes with recurrent diabetic macular edema - 36 months ... And then? (Abstract Channel) - Sep 28, 2020 - Abstract #EURETINA2020EURETINA_883; In our study, two thirds of the eyes (14/22) showed no signs of macular edema after 3 years of Fac implant and did not require reinjection; in some cases, we verified absence of edema even after 4 years of the Fac implant. Eyes that received a new fluocinolone acetonide implant (8/22) at month 36, presented visual and anatomical gains, maintained for, at least, another 12 months.These results suggest that ILUVIEN® can lead to sustained inflammation control, in situations of recurrent macular edema, and, consequently, prevent the recurrence of edema.
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Clinical, Review, Journal: Clinical-Decision Criteria to Identify Recurrent Diabetic Macular Edema Patients Suitable for Fluocinolone Acetonide Implant Therapy (ILUVIEN) and Follow-Up Considerations/Recommendations. (Pubmed Central) - Aug 18, 2020 In this regard, a 36-month follow-up consensus protocol is presented. In conclusion, patients that achieve a complete or partial anatomical, and preferably functional, response following one or two intravitreal dexamethasone implants, but with recurrence of edema after 3-4 months, are deemed by the authors most likely to benefit from ILUVIEN, and the switch to FAc implant should not be delayed more than 12 months after the initiation of at least the first dexamethasone implant.
- |||||||||| Iluvien (fluocinolone acetonide) / Alimera Sci, EyePoint Pharma
Clinical, Journal: Clinical impact of the 0.2 µg/day fluocinolone acetonide intravitreal implant: outcomes from the ILUVIEN clinical evidence study in Portugal. (Pubmed Central) - Jun 19, 2020 At 12-month post-fluocinolone acetonide, a small but significant intraocular pressure increase of 1.0 mmHg was seen in the overall study population. The results of this analysis show that switching from the current standard of care to the fluocinolone acetonide implant leads to beneficial effects in terms of vision and retinal structure in patients with diabetic macular edema and that patients benefited from FAc implant administration, regardless of lens status.
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Journal: Preliminary evaluation of YUTIQ™ (fluocinolone acetonide intravitreal implant 0.18 mg) in posterior uveitis. (Pubmed Central) - Jun 9, 2020 The treatment goal is to target the site of inflammation with low dose of corticosteroids, delivered over an extended period of time, to minimize the cumulative damage resulting from repeated recurrences, reducing both injections frequency and ocular side effects. This article will review the pharmacology and preliminary clinical data of the 0.18 mg fluocinolone acetonide intravitreal implant (YUTIQ™), to show its efficacy and safety in the treatment of noninfectious posterior uveitis.
- |||||||||| Decadron (dexamethasone) / Merck (MSD), Dexycu (dexamethasone intraocular injection) / EyePoint Pharma, Ocumension Therap
[VIRTUAL] Evaluation of Intraoperative Use of Dexycu on the Signs and Symptoms of Dry Eye (VM) - May 23, 2020 - Abstract #ASCRSASOA2020ASCRS-ASOA_2139; Purpose To evaluate the impact of intraoperative Dexycu (9% dexamethasone) administered intraoperatively during cataract surgery on the postoperative signs and symptoms of dry eye...The standard postoperative cataract regimen included topical gatifloxacin and topical prednisolone acetate...Standard regimen of topical steroid and antibiotic does not improve postoperative dry eye signs. Additional studies should be done to assess if Dexycu without the use of concurrent topical steroid impacts dry eye signs and symptoms.
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Journal: Dexamethasone intracameral drug-delivery suspension for inflammation associated with vitreoretinal surgery. (Pubmed Central) - May 20, 2020 No serious ocular adverse events were noted up to POD 90 in either group. The ICD drug-delivery suspension placed in the anterior chamber after vitreoretinal surgery was more effective than topical corticosteroids in treating inflammation occurring 1 week following vitreoretinal surgery and thus may be an alternative to daily corticosteroid drop installation in this patient population.
- |||||||||| Dexycu (dexamethasone intraocular injection) / EyePoint Pharma, Ocumension Therap
Trial completion: DEXYCURetro: DEXYCU (Dexamethasone Intraocular Suspension) 9% Retrospective Study 001 (clinicaltrials.gov) - May 4, 2020 P=N/A, N=527, Completed, Whilst there were many changes in the care of people with DME over this time, these data all support the value of treatment with FAc intravitreal implant. Active, not recruiting --> Completed
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Trial completion date, Trial primary completion date, Surgery: A Prospective Clinical Study Evaluating Dexycu vs Prednisolone Acetate 1% (clinicaltrials.gov) - Apr 19, 2020 P2, N=30, Recruiting, It's extended-release format for up to 3 years benefits to the patient and carer as it means fewer injections and visits to the clinic. Trial completion date: Jun 2020 --> Dec 2020 | Trial primary completion date: Mar 2020 --> Nov 2020
- |||||||||| Iluvien (fluocinolone acetonide) / Alimera Sci, EyePoint Pharma
Additional treatments of DME following treatment with the 0.19 mg fluocinolone acetonide implant: Results from the Retro-IDEAL study. (Exhibit Hall: Posterboard# B0041) - Mar 9, 2020 - Abstract #ARVO2020ARVO_5647; Purpose To assess the eyes that needed additional treatments over the entire period of 3 years.Methods The Retro-IDEAL study is a retrospective study designed to evaluate real-world outcomes in DME-patients treated with the 0.19 mg fluocinolone acetonide [FAc; ILUVIEN®]) implant...These results support an earlier switch from insufficiently responsive therapies. However, further correlation analysis of the subgroup without additional treatments is needed.
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The impact of changes at the vireoretinal interface and retinal thickness following the administration of a single 0.19 mg fluocinolone acetonide (FAc, ILUVIEN) device, implanted after partial PPV in patients with persistent or recurrent DME – results from the ILUVIT study, a single center, phase IV study. (Exhibit Hall: Posterboard# B0034) - Mar 9, 2020 - Abstract #ARVO2020ARVO_5640; P4 In contrast, the absence of vitreoretinal traction led to pronounced changes in CRT (-65.4 µm, p=0.24) and ART (-35.62 µm, p=0.165).Analyses of cytokine and chemokine expression showed the FAc implant led to consistent changes (i.e. >20% change from baseline) in IP-10, MCP-1, and CD-54 in both groups, but not for IL-6, IL-8, VEGF and PIGF, where changes (>20% from baseline) were only observed in the absence of vitreoretinal traction at baseline.Conclusions In this exploratory analysis, pPPV, which leads to partial reduction of vitreous volume and separation from the retinal surface, positively affected the course of DME in the patients studied.ILUVIEN, a sustained drug delivery device implanted into the vitreous cavity, treats a persistent or recurrent edema of the retina related to diabetes mellitus. Both, the retinal thickness and the interface between the retina and the vitreous cavity, respond to the ILUVIEN therapy; they can be analyzed non-invasively and are indicators for the state of disease.
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Real-life long-term outcomes for patients treated with the 0.19 mg fluocinolone acetonide (FAc; ILUVIEN) intravitreal implant for DME: Three-year follow-up from the RegIstry Safety Study (IRISS). (Exhibit Hall: Posterboard# B0026) - Mar 9, 2020 - Abstract #ARVO2020ARVO_5632; P=N/A During follow-up, VA remained stable / improved in 71% of eyes; ≥6/12 vision was achieved in 32% of eyes (vs. 18.6% at baseline; Figure); and, no significant changes were observed in eyes with a starting VA of ≥6/12.Conclusions These real-life outcomes confirm the long-term safety and effectiveness of the FAc implant in the treatment of DME after three years of treatment and in a cohort of patients larger than the EU registration trial population. The results from clinical practice show changes in IOP and visual acuity similar to those reported in the pivotal FAME trials and that in patients with good starting VA (≥70 letters) vision was stabilised for three years.
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Early treatment with the 0.19 mg fluocinolone acetonide implant is associated with improved functional and anatomical outcomes in patients with persistent or recurrent diabetic macular edema (Exhibit Hall: Posterboard# B0013) - Mar 9, 2020 - Abstract #ARVO2020ARVO_5618; Purpose Comparison of anatomical and functional outcomes with a single fluocinolone acetonide (0.19 mg FAc implant, ILUVIEN®) implant following suboptimal responses to ≤6 (early intervention) or > 6 prior intravitreal injections (IV) (late intervention).Methods Retrospective analysis of 34 eyes with DME that persisted or recurred despite treatment...The percentage of eyes gaining ≥15 letters and the overall reduction in CFT were numerically grater in group A (≥15 letters, 62.5% vs. 37.5% [group A vs. group B, respectively]; CFT, -234.2 µm vs. -182.1 µm). IOP remained stable over time in both groups.Conclusions Early intervention with the FAc implant tended to favor improved functional and anatomical outcomes in the current analyses, suggesting the early detection of suboptimal responses to prior therapies is important in achieving the best outcomes for patients with persistent or recurrent DME.
- |||||||||| Dexycu (dexamethasone intraocular injection) / EyePoint Pharma, Ocumension Therap
Dexamethasone Intracameral Drug-Delivery Suspension for Inflammation Associated with Vitreoretinal Surgery (Exhibit Hall: Posterboard# A0406) - Mar 9, 2020 - Abstract #ARVO2020ARVO_5132; Purpose To evaluate the efficacy of an anterior chamber intracameral dexamethasone drug-delivery suspension (Dexycu; EyePoint Pharmaceuticals, Watertown, MA) that provides medication for up to 21 days with a single application in treating postoperative inflammation in patients undergoing vitreoretinal surgery compared to daily post-operative treatment with topical corticosteroids for up to 1 month.Methods Retrospective case-matched comparison of patients undergoing initial vitreoretinal surgery by a single surgeon...Does a small injection after vitreoretinal surgery result in a similar post-operative anti-inflammatory effect as topical corticosteroids in patients undergoing vitreoretinal surgery? This intra-operative option may reduce the need for patients otherwise required to use post operative eye drops for a month after vitreoretinal surgery.
- |||||||||| Dexycu (dexamethasone intraocular injection) / EyePoint Pharma, Ocumension Therap
Outcomes of dexamethasone intraocular suspension during cataract surgery and concomitant cataract-micro-invasive glaucoma surgery (MIGS) (Exhibit Hall: Posterboard# B0340) - Mar 9, 2020 - Abstract #ARVO2020ARVO_4935; Purpose Dexamethasone intraocular suspension 9% (DEXYCU®) offers a sustained-release, FDA-approved alternative to anti-inflammatory drops...Given that atrophy was location-specific, occurring with 45% of AC aliquots, it may be mitigated by confining the aliquot to the ciliary sulcus. Further research should be pursued to determine how surgical technique, eye features, and drug properties affect sulcus escape.
- |||||||||| Iluvien (fluocinolone acetonide) / Alimera Sci, EyePoint Pharma
Diabetic Retinopathy Progression in Anti-VEGF vs. Fluocinolone Acetonide Implant treated eyes who are Lost to Followup (Exhibit Hall: Posterboard# B0285) - Mar 9, 2020 - Abstract #ARVO2020ARVO_524; Moreover, progression of DR and rates of visually threatening sequelae of PDR were lower in the Iluvien vs. anti-VEGF cohorts.Patients with diabetes that has affected their eyes can have worsening of the diabetes in their eyes if they are lost to followup and do not receive proper treatment. A long acting steroid implant may reduce the complications of diabetes in the eyes as compared to no treatment at all.
- |||||||||| Iluvien (fluocinolone acetonide) / Alimera Sci, EyePoint Pharma
Clinical, Journal: Effect of fluocinolone acetonide 0.2 μg/day implant on the decision to drive in patients with diabetic macular oedema: a report from the FAME study. (Pubmed Central) - Jan 10, 2020 This study aimed to determine whether treatment with the 0.2 µg/day fluocinolone acetone implant (FAc; ILUVIEN, Alimera Sciences) and the associated improvements in best-corrected visual acuity (BCVA) and central subfield thickness (CST) demonstrated in the Fluocinolone Acetonide in Diabetic Macular Edema (FAME) study have an impact on the patient's decision to drive as measured by the National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ-25)...Significant improvements in DSS score were also observed in quartile 1 (p=0.024), while numerical-but not significant-improvements in DSS score were observed in the full cohort. This post hoc analysis demonstrates a significant association between clinical outcomes in diabetic macular oedema and improvement in quality of life measures following a single FAc implant.
- |||||||||| Ozurdex (dexamethasone intravitreal implant) / Allergan, Iluvien (fluocinolone acetonide) / Alimera Sci, EyePoint Pharma
Fluocinolone acetonide for the treatment of chronic diabetic macular edema: an Italian real‐world experience () - Dec 24, 2019 - Abstract #EVER2019EVER_160; Purpose This is a retrospective real‐world study on the use of Fluocinolone acetonide (FAc) intravitreal implant (Iluvien®) for the treatment of chronic diabetic macular edema (DME) insufficiently responsive to available therapies...The study partecipants were all previously unsuccessfully treated with first‐line therapies (anti‐VEGF and laser) and intravitreal dexamethasone (Ozurdex®)...Selecting patients previously treated with intravitreal steroids and without increase in IOP can further minimize risks. Mean increase of IOP over time can be safely managed with topical therapy in the large majority of cases.
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