Xipere (triamcinolone acetonide) / Clearside Biomedical, Bausch Health, Arctic Vision, Santen - LARVOL DELTA

The Evolving Role of Suprachoroidal Drug Delivery in Macular Diseases: A Decade-Long Literature Review (ARVO 2025) - "Key findings include:Review Articles: A total of 35 articles discussed the potential applications of suprachoroidal injections for delivering small molecule suspensions, biologics, and gene therapy.Clinical Development: Ten studies covered the development of CLS-TA, culminating in FDA approval.Therapeutic Applications: Numerous case reports and case series described the use of suprachoroidal injections with various agents to manage retinal diseases, such as diabetic macular edema and retinal vein occlusion, either alone or in combination with anti-VEGF therapies.Emerging Therapies: Recent focus of suprachoroidal injection to deliver axitinib (a tyrosine kinase inhibitor with anti-VEGF activity) for wet age-related macular degeneration as well as gene therapy delivery.Technique Adoption: Expert guidelines and a user survey revealed that once the injection technique is mastered, 92% of practitioners found it easy to perform. Layman Abstract (optional): Provide a 50-200..."

Review • Age-related Macular Degeneration • Diabetic Macular Edema • Macular Degeneration • Ophthalmology • Retinal Disorders • Retinal Vein Occlusion • Wet Age-related Macular Degeneration

Duration of effect using triamcinolone acetonide suprachoroidal injectable suspension for macular edema in a large retinal practice. (ARVO 2025) - "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."

Macular Edema • Ophthalmology

Utilization of Triamcinolone Acetonide Suprachoroidal Injection by Diagnosis in a Large Retinal Practice (ARVO 2025) - "Purpose To evaluate the utilization of triamcinolone acetonide suprachoroidal injectable suspension (TASI) by diagnosis...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."

Macular Edema • Ocular Inflammation • Ophthalmology • Uveitis

Eat more, often: The capacity of piscivores to meet increased energy demands in warming oceans. (PubMed, Sci Total Environ) - "We investigated this dichotomy in the thermal foraging responses of Arc-eye hawkfish (Paracirrhites arcatus) and blacktail snapper (Lutjanus fulvus), evaluating energetic demand (standard metabolic rate, SMR), AS, appetite (meal mass intake), and capacity for digestion (specific dynamic action, SDA)...Although larger meals take longer to digest, both species exhibited faster digestion with rising temperatures resulting in a maintained or shortened SDA duration during MHWs, simultaneously enabling increased feeding rates while preserving aerobic reserves to support heightened predation. Our findings underscore the physiological feasibility of increasing appetite for some piscivores, while highlighting the ecological challenge of increasing prey numbers and sizes amid declining prey densities and prey size-reductions caused by ocean warming."

Journal

Clearside Biomedical’s Asia-Pacific Partner, Arctic Vision, Announced Acceptance of its New Drug Application for ARCATUS for Regulatory Review in China for the Treatment of Uveitic Macular Edema (GlobeNewswire) - "Clearside Biomedical, Inc...reported that Arctic Vision’s New Drug Application (NDA) for ARCATUS for the treatment of uveitic macular edema (UME) has been formally accepted for review by the Center for Drug Evaluation of China National Medical Products Administration. The NDA submission is supported by positive topline results from Arctic Vision’s Phase 3 UME clinical trial in China."

China filing • Ocular Inflammation • Retinal Disorders

Comparative metagenomics of tropical reef fishes show conserved core gut functions across hosts and diets with diet-related functional gene enrichments. (PubMed, Appl Environ Microbiol) - "To understand how fish gut microbial communities are shaped by diet, three tropical fish species (hawkfish, Paracirrhites arcatus; yellow tang, Zebrasoma flavescens; and triggerfish, Rhinecanthus aculeatus) were fed piscivorous (fish meal pellets), herbivorous (seaweed), and invertivorous (shrimp) diets, respectively...We found evidence that fish gut microbial communities share several core functions despite differences in microbial taxonomy. Herbivorous fish harbored a functionally diverse microbial community with plant matter degraders, while the piscivorous and invertivorous fish had microbiomes more specialized in protein degradation."

Journal • Targeted Protein Degradation

Clearside Biomedical Announces its Asia-Pacific Partner, Arctic Vision, Received Approval of Suprachoroidal Treatment for Uveitic Macular Edema in Australia and Singapore (GlobeNewswire) - "Clearside Biomedical, Inc...announced today that Arctic Vision’s new drug applications for ARCATUS (triamcinolone acetonide 4 mg/0.1 mL injection suspension vial kit) have been approved by the Therapeutic Goods Administration of Australia and the Health Sciences Authority in Singapore for the treatment of uveitic macular edema (UME)."

Approval • Ocular Inflammation • Retinal Disorders

Suprachoroidal drug delivery: a versatile therapeutic platform. (PubMed, Expert Opin Drug Deliv) - No abstract available

Journal • Age-related Macular Degeneration • Diabetic Retinopathy • Gene Therapies • Macular Degeneration • Macular Edema • Ocular Inflammation • Ophthalmology • Retinal Disorders • Uveitis

Serial Tonometry Following Intraocular Injections: How Does Injection Volume Affect IOP? (AAO 2024) - "Methods Serial tonometry was performed for 269 injections in 144 patients treated with either a “standard” (0.05 mL) or “high”-volume injection: 8 mg/0.07mL aflibercept (Eylea HD) IVI, 15 mg/0.1mL pegcetacoplan (Syfovre) IVI or 4 mg/0.1mL triamcinolone (Xipere) SCI. Therapeutic aqueous paracentesis was performed more frequently for 0.1-mL versus 0.05-mL injections (54/99; 3/32; P ∼ 10-5). Conclusion The higher injection volume of recently approved retinal therapeutics is associated with higher immediate and more prolonged IOP elevation."

Glaucoma • Ophthalmology

Suprachoroidal Drug Delivery for Macular Edema Associated With Noninfectious Uveitis. (PubMed, J Vitreoretin Dis) - " In 2021, suprachoroidal space triamcinolone acetonide, a corticosteroid delivery system used for the treatment of uveitic macular edema (ME), was approved by the US Food and Drug Administration... The safety and efficacy of suprachoroidal corticosteroid injections to treat uveitic ME have been shown in recent phase III clinical trials. Multiple programs are also investigating this modality of drug delivery for use in many other retinal and choroidal pathologies."

Journal • Age-related Macular Degeneration • Choroidal Melanomas • Macular Degeneration • Macular Edema • Melanoma • Ocular Inflammation • Ocular Melanoma • Oncology • Ophthalmology • Retinal Disorders • Retinal Vein Occlusion • Solid Tumor • Uveitis

SUPRACHOROIDAL TRIAMCINOLONE ACETONIDE FOR REFRACTORY POSTOPERATIVE CYSTOID MACULAR EDEMA. (PubMed, Retina) - "Suprachoroidal triamcinolone acetonide reduced macular edema and improved vision in refractory postoperative cystoid macular edema, including vitrectomized eyes. Intraocular pressure should be monitored, especially in those with a history of glaucoma or ocular hypertension."

Journal • Retrospective data • Cardiovascular • Glaucoma • Macular Edema • Ophthalmology

Despite plasticity, heatwaves are costly for a coral reef fish. (PubMed, Sci Rep) - "Here, we investigated how marine heatwave conditions affected the performance and thermal tolerance of a tropical predatory fish, arceye hawkfish (Paracirrhites arcatus), across two seasons in Moorea, French Polynesia...Additionally, hawkfish that were exposed to hotter temperatures exhibited cardiac plasticity by increasing their maximum heart rate but were still operating within a few degrees of their thermal limits. With more frequent and intense heatwaves, hawkfish, and other tropical fishes must rapidly acclimate, or they may suffer physiological consequences that alter their role in the ecosystem."

Journal

Serial tonometry following intravitreal and suprachoroidal injections: What is the effect of injection volume on intraocular pressure? (ARVO 2024) - "Higher volumes of administration are recommended for recently approved products, including 8mg/0.07mL intravitreal aflibercept (HD Eylea), 15mg/0.1mL intravitreal pegcetacoplan (Syfovre), and 4mg/0.1mL suprachoroidal injection (SCI) of triamcinolone (Xipere). Higher injection volumes appear to be associated with a greater rise in IOP immediately following IVI and more prolonged exposure to IOP >35 mmHg. This study supports the medical necessity of serial tonometry to monitor IOP following higher volume injections."

Ophthalmology

Angiographic response to suprachoroidal triamcinolone acetonide (CLS-TA) in eyes with noninfectious uveitis (ARVO 2024) - "While suprachoroidal CLS-TA is effective for the treatment of uveitic macular edema, it has minimal impact on vascular leakage on FA, a key outcome measure in the treatment of uveitis. Eyes with significant vascular leakage on FA may require supplemental or alternative treatment with systemic or local therapies to achieve disease control."

Macular Edema • Ocular Inflammation • Ophthalmology • Uveitis

Suprachoroidal triamcinolone acetonide in eyes with a scleral buckle (ARVO 2024) - "Outcomes of suprachoroidal triamcinolone acetonide (CLS-TA) injection in eyes with scleral buckles for UME are modest. While outcomes were favorable in eyes in which no significant egress of the medication was noted during the injection, in eyes in which there is egress of the medication during the injection, an alternative treatment modality may need to be considered."

Macular Edema • Ocular Inflammation • Ophthalmology • Retinal Disorders • Uveitis

Safety and Efficacy of CLS-TA by Anatomic Location of Inflammation: Results from the Phase 3 PEACHTREE Clinical Trial. (PubMed, Ocul Immunol Inflamm) - "To explore the efficacy of CLS-TA, a proprietary suprachoroidal injectable suspension of triamcinolone acetonide, in noninfectious uveitis (NIU) with macular edema (ME), categorized by anatomic subtype. Overall, reports of adverse events were similar among subtypes. Irrespective of the uveitic anatomic subtype among patients treated for ME associated with NIU, a clinical benefit in participants treated with CLS-TA was demonstrated, with a comparable safety profile."

Journal • P3 data • Inflammation • Macular Edema • Ocular Inflammation • Ophthalmology • Uveitis

Experience With Triamcinolone Acetonide Suprachoroidal Injection for Uveitic Macular Edema: A Physician Survey (AAO 2023) - "Purpose To report on physicians' early experience with suprachoroidal injection of triamcinolone acetonide injectable suspension (SCS-TA; Xipere) for uveitic macular edema...No new safety signals emerged. Conclusion Physicians found SCS-TA injection easy to learn, with patient outcomes consistent with clinical trial data."

Macular Edema • 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

Early Adoption of Triamcinolone Acetonide Suprachoroidal Injection for Uveitic Macular Edema: A Physician Survey (ARVO 2023) - "Purpose Triamcinolone acetonide injectable suspension (SCS-TA; Xipere) for suprachoroidal (SC) use was recently approved in the U.S. for the treatment of uveitic macular edema (UME)...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."

Macular Edema • 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

Optical coherence tomography outcomes as biomarkers for disease status, visual function, and prognosis in diabetic macular edema. (PubMed, Can J Ophthalmol) - "DRIL area and DRIL maximum horizontal extent were demonstrated to be novel biomarkers for macular edema status, visual function, and prognosis in eyes with treatment-naive DME."

Biomarker • Journal • Diabetic Macular Edema • Ophthalmology

Suprachoroidal triamcinolone acetonide injectable suspension for macular edema associated with noninfectious uveitis: an in-depth look at efficacy and safety. (PubMed, Am J Manag Care) - P=N/A, P3 | "A novel triamcinolone acetonide (TA) injectable suspension formulated for administration to the SCS, SCS-TA (Xipere®; Bausch + Lomb), received FDA approval in 2021 for the treatment of UME. This approval was based on results from the phase 3 PEACHTREE clinical trial (NCT02595398) that demonstrated the clinical efficacy-including significantly increased visual acuity and decreased central subfield thickness-and safety of SCS-TA in patients with UME. Results from this trial, as well as from its long-term observational extension (MAGNOLIA; NCT02952001) and an open-label safety study (AZALEA; NCT03097315), support the possibility that treatment with SCS-TA may address the burden of disease in patients with UME."

Journal • Macular Edema • Ocular Inflammation • Ophthalmology • Uveitis

Microinjection via the suprachoroidal space: a review of a novel mode of administration. (PubMed, Am J Manag Care) - P=N/A, P3 | "Successful use of SCS injection has been demonstrated with triamcinolone acetonide injectable suspension (Xipere®, Bausch + Lomb), a novel formulation optimized for use with the SCS Microinjector®. FDA approval of this combination drug and device for the treatment of macular edema associated with uveitis (UME) was based on outcomes from the phase 3 PEACHTREE study (NCT02595398); other important studies included its long-term observational extension (MAGNOLIA; NCT02952001) and an open-label safety study (AZALEA; NCT03097315). The SCS Microinjector® together with triamcinolone acetonide injectable suspension for use in the SCS presents an opportunity for safe and effective drug delivery for the treatment of UME and, potentially, for broader use with alternate medications to treat other ocular diseases that impact chorioretinal tissues (eg, age-related macular degeneration, diabetic retinopathy, choroidal melanoma)."

Journal • Review • Age-related Macular Degeneration • Anesthesia • Choroidal Melanomas • Diabetic Retinopathy • Macular Degeneration • Macular Edema • Melanoma • Ocular Inflammation • Ocular Melanoma • Oncology • Ophthalmology • Retinal Disorders • Solid Tumor • Uveitis

Triamcinolone Acetonide Suprachoroidal Injectable Suspension for Uveitic Macular Edema: Integrated Analysis of Two Phase 3 Studies. (PubMed, Ophthalmol Ther) - P3 | "In this integrated analysis utilizing strict inclusion criteria, SCS-TA was found effective in the treatment of patients with macular edema associated with noninfectious uveitis and was generally well tolerated."

Journal • P3 data • Cataract • Diabetic Retinopathy • Macular Edema • Ocular Inflammation • Ophthalmology • Retinal Disorders • Uveitis

Triamcinolone acetonide injectable suspension for suprachoroidal use in the treatment of macular edema associated with uveitis. (PubMed, Expert Rev Ophthalmol) - "Triamcinolone acetonide injectable suspension for suprachoroidal use (Xipere) is an alternative treatment option for patients with non-infectious uveitis associated macular edema. This unique delivery method suggests the potential to decrease side effects of anterior segment exposure such as glaucoma and cataract, but head-to-head trials are needed for further study of safety and efficacy. Additionally, there are promising prospective studies underway for utilization of the suprachoroidal space for other diseases including macular degeneration, diabetic macular edema, and ocular tumors."

Journal • Age-related Macular Degeneration • Cataract • Diabetic Macular Edema • Eye Cancer • Glaucoma • Immunology • Inflammation • Macular Degeneration • Macular Edema • Ocular Inflammation • Ocular Melanoma • Oncology • Ophthalmology • Retinal Disorders • Uveitis