Retisert (fluocinolone acetonide intravitreal implant) / Bausch Health, EyePoint Pharma - LARVOL DELTA

Concurrent Keratoprosthesis and Fluocinolone Acetonide Implant: Short-Term Outcomes (ARVO 2025) - "Purpose To evaluate the safety and efficacy of combined Boston Type 1 Keratoprosthesis (Kpro) with fluocinolone acetonide intravitreal 0.59 mg implant (Retisert)...Layman Abstract (optional): Provide a 50-200 word description of your work that non-scientists can understand. Describe the big picture and the implications of your findings, not the study itself and the associated details."

Ocular Infections • Ocular Inflammation • Ophthalmology • Retinal Disorders • Uveitis

Intravitreal steroid implants in the management of noninfectious intermediate and posterior uveitis. (PubMed, Indian J Ophthalmol) - "Since the emergence of intravitreal implants (Vitrasert, Retisert), it has become possible to circumvent these therapeutic challenges...This review article also provides insights into dexamethasone (Ozurdex) and recent fluocinolone acetonide (Yutiq, Iluvien) implants with particular emphasis on their improved safety and efficacy. Dexamethasone implants favor the therapeutic goal of prevention of recurrences, whereas the use of fluocinolone implants helps to attain better visual outcomes due to their longer duration of action. Thus, the review provides recent literature supporting the role and indication of sustained release intravitreal implants in the management of noninfectious intermediate and posterior uveitis."

Journal • Ocular Inflammation • Ophthalmology • Uveitis

Retisert implantation without incisional sclerotomy in patients with uveitis and extensive pars plana fibrosis. (PubMed, Am J Ophthalmol Case Rep) - "Retisert can be implanted via the anterior chamber in patients with extensive fibrosis in the pars plana and pars plicata regions. This approach may minimize the risk of retinal traction and damage to the implant when compared to the traditional full-thickness sclerotomy method in these high-risk cases."

Journal • Fibrosis • Immunology • Ocular Inflammation • Ophthalmology • Retinal Disorders • Uveitis

Leakage quantification on fluorescein angiography after 0.59 mg fluocinolone acetonide intravitreal implant in patients with Birdshot Chorioretinopathy (ARVO 2024) - "Current treatment options for BCR include surgical fluocinolone acetonide implants (Retisert, Bausch and Lomb)... In this study we have shown that the majority of patients with BCR treated with surgical fluocinolone acetonide demonstrated a reduction in total retinal leakage on FA compared to baseline, and few had a recurrence of that leakage. Quantitative analysis of leakage using UWFA has clinical utility in measuring response to treatment in patients with BCR."

Clinical • Ocular Inflammation • Ophthalmology • Retinal Disorders

Boston Type 1 Keratoprosthesis Combined with Silicone Oil and Retisert Implant for the Treatment of Pre-phthisical Eyes (AAO 2023) - "No patient developed endophthalmitis. Conclusion Boston Type 1 KPro combined with SO improves visual acuity for prephthisical eyes, and placement of a Retisert implant may be associated with lower rate of retroprosthetic membrane formation."

Ocular Infections • Ocular Inflammation • Ophthalmology

Long-term quantification of ellipsoid zone changes on optical coherence tomography in patients with Birdshot Chorioretinopathy (ARVO 2023) - "Current treatment options for BCR include systemic immunomodulatory therapy (IMT) and surgical fluocinolone acetonide (FA) implants (Retisert, Bausch and Lomb)...Layman Abstract (optional): Provide a 50-200 word description of your work that non-scientists can understand. Describe the big picture and the implications of your findings, not the study itself and the associated details."

Clinical • Ophthalmology • Retinal Disorders

Therapeutic Effects of Combination Therapy and Photobiomodulation Therapy on Retinal Regeneration. (PubMed, J Lasers Med Sci) - " We investigated the effects of various lasers photocoagulation such as Focal and/or grid macular laser, subthreshold micropulse laser (SMPL), as well as intravitreal pharmacotherapies with triamcinolone acetonide, and fluocinolone, and extended released intraocular implants such as Ozurdex, Retisert, Iluvien, and anti-vascular endothelial growth factors such as bevacizumab (Avastin), Eyela, and Lucentis...Therefore, combining the medication with a laser is much more reasonable than each alone. Also, the subthreshold photocoagulation laser (670 nm) is better at reducing the central macular thickness (CMT) and improving VA than the micro pulse yellow laser and pan-retinal photocoagulation (PRP)."

Combination therapy • Journal • Review • Diabetic Macular Edema • Glaucoma • Ophthalmology

Long-term Dose-controllable Drug Delivery Implant (ARVO 2022) - "Purpose: Repetitive intravitreal injections of drug or intravitreal injections of sustained-release corticosteroid implants (Ozurdex, Retisert, and Iluvien) are the current standard of care for the chronic diseases. We successfully showed effective drug release from a nanoporous PLGA implant using pulsed NIR laser irradiation both in vitro and in vivo. The drug delivery system was safe and stable against leakage for 6 months. The light-activated drug delivery system that we developed will provide tightly-controlled release without burst release."

Cataract • Glaucoma • Ophthalmology

Keratoprosthesis, silicone oil placement, and fluocinolone acetonide implant for treatment of uveitis-associated hypotony and keratopathy. (PubMed, J Ophthalmic Inflamm Infect) - "The approach described is potentially safe and effective in preventing phthisis and membrane formation in uveitis-associated hypotony and keratopathy."

Journal • Ocular Infections • Ocular Inflammation • Ophthalmology • Uveitis

Yutiq - another fluocinolone intravitreal implant for uveitis. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Ocular Inflammation • Ophthalmology • Uveitis

Steroid delivery systems in uveitis (Ophthalmology Management) - "The administration of steroids can vary (topical, systemic, periocular, intravitreal or intraocular depot) depending on the cause, location and severity of disease....Fortunately, the compartmentalized anatomy of the eye has allowed multiple novel methods of local depot steroid delivery systems. These delivery systems optimize the inherent benefits of corticosteroids while reducing the known corticosteroid side effects (systemic and/or ocular). Intraocular nanoparticles and microparticles also show great promise in the targeted delivery of therapeutics and will likely be pivotal drug delivery platforms in the future. Ultimately, however, the cost of these medications and their ability to reduce treatment burden will be critical in forging their acceptance in the clinical setting."

Online posting

Safety and Efficacy Study of a Fluocinolone Acetonide Intravitreal (FAI) Insert in Subjects With Chronic Non-infectious Posterior Uveitis (clinicaltrials.gov) - P3; N=153; Active, not recruiting; Sponsor: pSivida Corp.; Recruiting ➔ Active, not recruiting

Enrollment closed • Biosimilar • Complement-mediated Rare Disorders • Immunology • Ocular Inflammation • Ophthalmology

Safety and Efficacy of an Injectable Fluocinolone Acetonide Intravitreal Insert (clinicaltrials.gov) - P3; N=129; Active, not recruiting; Sponsor: pSivida Corp.; Recruiting -> Active, not recruiting ; Trial primary completion date: Jul 2015 ->Mar 2018

Enrollment closed • Biosimilar • Immunology • Inflammation • Ocular Inflammation

Safety and Efficacy Study of a Fluocinolone Acetonide Intravitreal (FAI) Insert in Subjects With Chronic Non-infectious Posterior Uveitis (clinicaltrials.gov) - P3; N=150; Recruiting; Sponsor: pSivida Corp.

New P3 trial • Biosimilar • Complement-mediated Rare Disorders • Immunology • Ocular Inflammation • Ophthalmology

Long-term Outcomes of Glaucoma Drainage Implants in Uveitic Eyes with Fluocinolone Acetonide Implants. (PubMed, J Glaucoma) - "In eyes with uveitis that undergo FA implantation, concurrent or subsequent GDI surgery offers excellent long-term control of IOP. Post-operative IOP and number of IOP-lowering medications dropped considerably and remained stable."

Journal • Complement-mediated Rare Disorders • Glaucoma • Immunology • Ocular Inflammation • Ophthalmology • Uveitis

A New Approach for Diabetic Macular Edema Treatment: review of clinical practice results with 0.19 mg fluocinolone acetonide intravitreal implant including vitrectomized eyes. (PubMed, Curr Ophthalmol Rep) - "Two extended-release (i.e. lasting up to 3 years) drug delivery systems containing fluocinolone acetonide (FAc) have been approved by the FDA for intravitreal use: Retisert ® (Bausch&Lomb, New Jersey, USA) and Iluvien ® (Alimera Sciences, Atlanta, USA). An increasing evidence of real-world studies have supported utility of the implant in DME patients. 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."

Clinical • Journal • Cataract • Complement-mediated Rare Disorders • Diabetes • Diabetic Macular Edema • Diabetic Retinopathy • Immunology • Macular Edema • Metabolic Disorders • Ocular Inflammation • Ophthalmology • Rare Diseases • Retinal Disorders • Uveitis

Safety and Efficacy of an Injectable Fluocinolone Acetonide Intravitreal Insert (clinicaltrials.gov) - P3; N=129; Completed; Sponsor: pSivida Corp.; Active, not recruiting ➔ Completed

Clinical • Trial completion

Evaluation of Corneal Endothelial Cell Density in Subjects Who Have Had a Fluocinolone Acetonide Implant (clinicaltrials.gov) - P=N/A; N=98; Completed; Sponsor: Bausch & Lomb Incorporated; Recruiting ➔ Completed; Trial completion date: May 2018 ➔ Jun 2019; Trial primary completion date: Mar 2018 ➔ Mar 2019

Clinical • Trial completion • Trial completion date • Trial primary completion date

Corneal Endothelial Cell Density in Eyes Treated With a Fluocinolone Acetonide Intravitreal Implant (clinicaltrials.gov) - P=N/A; N=3; Completed; Sponsor: Bausch & Lomb Incorporated; Not yet recruiting ➔ Completed; N=80 ➔ 3; Trial completion date: Aug 2020 ➔ Mar 2019; Trial primary completion date: Jul 2020 ➔ Sep 2018

Enrollment change • Trial completion • Trial completion date • Trial primary completion date

Long-Term Outcomes Of Glaucoma Tube Shunt Surgeries In Uveitic Eyes With Fluocinolone Acetonide Implants (AGS 2019) - "In eyes suffering from uveitic glaucoma that undergo fluocinolone acetonide implantation, a GDI offers excellent long-term control of glaucoma. Early GDI surgery should especially be considered in high risk cases as IOP-lowering medications alone are unlikely to control IOP in the presence of a fluocinolone acetonide implant."