Yutiq (fluocinolone acetonide intravitreal implant) / EyePoint Pharma - LARVOL DELTA

TYNI: The Use of Two YUTIQ Versus Sham for Treatment of Chronic Non Infectious Intraocular Inflammation Affecting the Posterior Segment (clinicaltrials.gov) - P3 | N=30 | Recruiting | Sponsor: Texas Retina Associates | Trial completion date: Dec 2024 ➔ Dec 2026 | Trial primary completion date: Dec 2023 ➔ Jul 2026

Trial completion date • Trial primary completion date • Inflammation • Ocular Infections • Ocular Inflammation • Ophthalmology • Uveitis

Treatment of Chronic Non-Infectious Posterior Uveitis (NIPU) with 0.18-mg Fluocinolone Acetonide (YUTIQ) Intravitreal Implant (ARVO 2025) - "24% of patients required topical corticosteroid therapy within a 12-month period post-FAc delivery, and 24% of patients required systemic management through either oral corticosteroids or steroid-sparing immunosuppressive therapies (i.e. TNF blockers such as infliximab and adalimumab). 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 • Uveitis

ANI Pharmaceuticals Announces Buyout of Royalty Obligation for ILUVIEN and YUTIQ (GlobeNewswire) - "ANI Pharmaceuticals, Inc...announced that it has completed the buyout of its 3.125% perpetual royalty obligation to SWK Funding LLC (SWK) on worldwide net revenues of ILUVIEN and YUTIQ for a one-time payment of $17.25 million. Under the terms of the agreement, upon making the buyout payment, no further royalty is due to SWK on net revenues beginning January 1, 2025, forward. ANI funded the buyout with cash on hand."

Commercial • Diabetic Macular Edema • Uveitis

ANI Pharmaceuticals Reports Record Fourth Quarter and Full-Year 2024 Financial Results and Raises 2025 Guidance (GlobeNewswire) - "Revenues for ILUVIEN and YUTIQ were $27.6 million for the fourth quarter, which was the first full quarter of ownership following the acquisition of Alimera Sciences...The Company has submitted a prior approval supplement (PAS) to the FDA seeking to add YUTIQ’s indication of chronic non-infectious uveitis affecting the posterior segment of the eye (NIU-PS) to the ILUVIEN label. The Company expects FDA approval of the PAS in the second quarter of 2025 and plans to market ILUVIEN for chronic NIU-PS in addition to its current indication of diabetic macular edema (DME) in the U.S."

Commercial • FDA event • Launch US • Diabetic Macular Edema • Uveitis

Intravitreal Sustained Release Steroid Implants Are Safe and Effective in Patients With Glaucoma Drainage Devices. (PubMed, Retina) - "Intravitreal steroid implants were safe and effective for the treatment of post-surgical CME in patients with pre-existing GDD. There was no increase in IOP and no increase in antihypertensive drops."

Journal • Glaucoma • Ocular Infections • Ocular Inflammation • Ophthalmology • Uveitis

A Study of Yutiq Steroid Insert During Glaucoma Tube Implant Surgery (clinicaltrials.gov) - P1 | N=5 | Active, not recruiting | Sponsor: Sanjay Asrani | Recruiting ➔ Active, not recruiting | Trial completion date: Dec 2024 ➔ Jun 2027 | Trial primary completion date: Dec 2024 ➔ Jun 2027

Enrollment closed • Surgery • Trial completion date • Trial primary completion date • Cataract • Glaucoma • Ophthalmology

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

Injectable Fluocinolone Implant for the Management of Cystoid Macular Edema in Coats' Disease. (PubMed, Ophthalmic Surg Lasers Imaging Retina) - "Given the excellent response to shorter acting steroids and the need for general anesthesia for each procedure, the patient underwent placement of the injectable fluocinolone acetonide implant 0.18 mg (YUTIQ) with control of his CME at 30 months of follow-up. The authors conclude that a long-acting steroid implant may be beneficial in select patients with Coats' disease. [Ophthalmic Surg Lasers Imaging Retina 2024;55:XX-XX.]."

Journal • Anesthesia • Macular Edema • Ophthalmology

Fluocinolone Acetonide Intravitreal Implant 0.18 mg in the Treatment of Chronic Non-Infectious Posterior Segment Uveitis (clinicaltrials.gov) - P4 | N=125 | Active, not recruiting | Sponsor: Alimera Sciences | Recruiting ➔ Active, not recruiting

Enrollment closed • Inflammation • Ocular Inflammation • Ophthalmology • Uveitis

Fluocinolone acetonide 0.2 µg/day intravitreal implant in non-infectious uveitis affecting the posterior segment: EU expert user panel consensus-based clinical recommendations. (PubMed, J Ophthalmic Inflamm Infect) - "As more clinical experience has been gained using FAc implants, it was necessary to update the clinical recommendations that guide patient management in the clinic. The current consensus document addresses relevant issues related to the use of FAc implants on different types of patients with various etiologies of NIU-PS, and was conducted to standardize approaches to help specialists obtain better clinical outcomes."

Journal • Review • Inflammation • Ocular Inflammation • Ophthalmology • Uveitis

Successful Treatment of Clinically Diagnosed Cancer-Associated Retinopathy with Intravitreal Dexamethasone Implant Followed by 0.18 mg Fluocinolone Implant without Systemic Immunosuppression. (PubMed, Retin Cases Brief Rep) - "The sustained improvements with intravitreal corticosteroid monotherapy suggest potential advantages using local therapy over systemic treatment. Long term follow-up is warranted. Further research is needed to evaluate the efficacy of using 0.18mg fluocinolone implant (YUTIQ) to treat CAR."

Journal • Cataract • CNS Lymphoma • Colon Cancer • Gastrointestinal Cancer • Hematological Malignancies • Lymphoma • Ocular Inflammation • Ocular Melanoma • Oncology • Ophthalmology • Retinal Disorders

Long-Term Clinical Outcomes of the 0.18 Mg Fluocinolone Acetonide Intravitreal Implant Following Local Corticosteroid Burst in Noninfectious Uveitis. (PubMed, Ocul Immunol Inflamm) - "No patient discontinued systemic therapy and on average 15.0% of eyes required additional local corticosteroids at each follow-up interval. This treatment approach demonstrates that the 0.18 mg FAi is a useful adjuvant for the treatment of noninfectious uveitis but may not be adequate as solo therapy."

Clinical data • Journal • Cataract • Glaucoma • Inflammation • Macular Edema • Ocular Inflammation • Ophthalmology • Uveitis • Vasculitis

Fluocinolone Acetonide Intravitreal Implant 0.18 mg in the Treatment of Chronic Non-Infectious Posterior Segment Uveitis (clinicaltrials.gov) - P4 | N=125 | Recruiting | Sponsor: Alimera Sciences | Trial completion date: Sep 2024 ➔ Nov 2025 | Trial primary completion date: Sep 2024 ➔ Nov 2025

Trial completion date • Trial primary completion date • Inflammation • Ocular Inflammation • Ophthalmology • Uveitis

Improvement of Postoperative Macular Edema Following Intravitreal Steroid Injections (AAO 2023) - "Methods Consecutive case series of 91 patients treated with Ozurdex (0.4-mg dexamethasone implant), Yutiq (0.19-mg fluocinolone implant) or Xipere (4 mg/0.1 mL suprachoroidal triamcinolone acetonide suspension). CST and MV improved significantly at 6 weeks (−129 μm, P ∼ 10-13; −0.88 mm³, P ∼ 10-11) and 3 months (−75 μm, P ∼ 10-6; −0.59 mm³, P ∼ 10-7). Conclusion All three FDA-approved steroid injections provided significant benefit for patients with postoperative ME at 6 weeks and 3 months after the initial injection."

Macular Edema • Ocular Inflammation • Ophthalmology • Uveitis

Safety and Efficacy of an Injectable Fluocinolone Acetonide Intravitreal Insert (FAI) (clinicaltrials.gov) - P3 | N=12 | Terminated | Sponsor: EyePoint Pharmaceuticals, Inc. | Active, not recruiting ➔ Terminated | Trial primary completion date: Apr 2023 ➔ Oct 2022; No longer pursuing indication

Trial primary completion date • Trial termination • Ocular Inflammation • Ophthalmology • Uveitis

"$ALIM Alimera Acquires U.S. Commercial Rights to YUTIQ® https://t.co/XkizB5x5Ny" (@stock_titan)

Intravitreal Fluocinolone Acetonide Implant for Radiation Retinopathy: Report of Preliminary Findings. (PubMed, Retina) - "Intravitreal FA implant is an effective treatment for CME radiation retinopathy. The slow release of steroid allows for sustained control of macular edema, which correlated with stable visual acuity and decreased injection burden for patients."

Journal • Eye Cancer • Macular Edema • Melanoma • Oncology • Ophthalmology • Retinal Disorders • Solid Tumor • Uveal Melanoma

CALM: A retrospective registry to characterize clinical outcomes for chronic non-infectious posterior segment uveitis patients treated with the 0.18 mg fluocinolone acetonide intravitreal insert: Intraocular Pressure and Safety Data Analysis (ARVO 2023) - "Of the 188 eyes enrolled, 98.4%, 1.06%, and .53% had 1, 2, and 3 Yutiq treatment per eye, respectively...Additionally, very few, if any, received cataract procedures and other surgical interventions, an indication of the FAi insert’s success. These findings indicate that the FAi insert, in addition to healing uveitis, can also decrease the risk of glaucoma and other safety hazards which are often common with long-term steroid implants."

Clinical data • Retrospective data • Cataract • Glaucoma • Ocular Inflammation • Ophthalmology • Uveitis

Initial Efficacy of Steroid Injections for Post-Operative Uveitic Macular Edema (ARVO 2023) - "There are now several FDA-approved steroid injections which are indicated for UME: Ozurdex (0.7mg dexamethasone intravitreal implant), Xipere (4mg/0.1mL triamcinolone acetate suprachoroidal suspension), and Yutiq (0.18mg flucinolone acetonide intravitreal implant). This study demonstrates that these steroid injections ALSO work well for patients with eye inflammation following eye surgery, particularly those WITHOUT a prior history of uveitis. This study suggests there may be a large population of patients who would benefit from these steroid injections."

Clinical • Diabetic Retinopathy • Macular Edema • Ocular Inflammation • Ophthalmology • Retinal Disorders • Uveitis

Safety and Efficacy of an Injectable Fluocinolone Acetonide Intravitreal Insert (FAI) (clinicaltrials.gov) - P3 | N=12 | Active, not recruiting | Sponsor: EyePoint Pharmaceuticals, Inc. | Recruiting ➔ Active, not recruiting | N=60 ➔ 12 | Trial primary completion date: Oct 2022 ➔ Apr 2023

Enrollment change • Enrollment closed • Trial primary completion date • Ocular Inflammation • Ophthalmology • Uveitis

TYNI: The Use of Two YUTIQ Versus Sham for Treatment of Chronic Non Infectious Intraocular Inflammation Affecting the Posterior Segment (clinicaltrials.gov) - P3 | N=30 | Recruiting | Sponsor: Texas Retina Associates | Not yet recruiting ➔ Recruiting

Enrollment open • Immunology • Inflammation • Ocular Infections • Ocular Inflammation • Ophthalmology • Uveitis

A Study of YUTIQ® 0.18 mg Intravitreal Implant for the Management of Chronic Non-infectious Uveitis (clinicaltrials.gov) - P=N/A | N=15 | Recruiting | Sponsor: Tianjin Medical University

New trial • Ocular Inflammation • Ophthalmology • Uveitis

TYNI: The Use of Two YUTIQ Versus Sham for Treatment of Chronic Non Infectious Intraocular Inflammation Affecting the Posterior Segment (clinicaltrials.gov) - P3 | N=30 | Not yet recruiting | Sponsor: Texas Retina Associates

New P3 trial • Immunology • Inflammation • Ocular Infections • Ocular Inflammation • Ophthalmology • Uveitis

Efficacy of the Fluocinolone Acetonide (Yutiq) Intravitreal Implant as Monotherapy for Uveitis. (PubMed, Ocul Immunol Inflamm) - "The fluocinolone acetonide implant may not suffice as monotherapy for all patients with uveitis, but it may be effective as an adjunctive treatment. We propose a clinical workflow for the selection and treatment of patients who may benefit from it."

Journal • Monotherapy • Immunology • Inflammation • Ocular Inflammation • Ophthalmology • Uveitis

Fluocinolone Acetonide Intravitreal Implant 0.18 mg in the Treatment of Chronic Non-Infectious Posterior Segment Uveitis (clinicaltrials.gov) - P4 | N=125 | Recruiting | Sponsor: EyePoint Pharmaceuticals, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Immunology • Inflammation • Ocular Inflammation • Ophthalmology • Uveitis