triamcinolone acetonide + anti-VEGF (CLS-1003) / Clearside Biomedical - LARVOL DELTA

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

Aflibercept With or Without Suprachoroidal CLS-TA for Diabetic Macular Edema: A Randomized, Double-Masked, Parallel-Design, Controlled Study. (PubMed, Ophthalmol Retina) - "CLS-TA administered suprachoroidally in conjunction with IVT aflibercept in the treatment of DME provides no visual benefit at 24 weeks follow up compared to IVT aflibercept monotherapy, but a modest anatomical benefit and the potential to reduce treatment burden. Ocular adverse events were low for both arms."

Clinical • Journal • Cataract • Diabetic Macular Edema • Ophthalmology

Clearside Biomedical Announces Multiple Presentations at the ASRS 2020 Virtual Annual Meeting (GlobeNewswire) - "Clearside Biomedical, Inc...announced today that multiple posters and oral presentations...were delivered at the American Society of Retina Specialists (ASRS) 2020 Virtual Annual Meeting....Suprachoroidal CLS-AX (axitinib injectable suspension), as a Potential Long-Acting Therapy for Neovascular Age-Related Macular Degeneration (nAMD)...David Brown....Variations in Intraocular Pressure Following Administration of Suprachoroidal Triamcinolone Acetonide Suspension (CLS-TA): Results from the Phase 3 PEACHTREE Clinical Trial for Uveitic Macular Edema...Quan Dong Nguyen."

Retrospective Study of the Safety and Efficacy of Patients With RVO in Subjects Who Completed Parent Study CLS1003-201 (clinicaltrials.gov) - P=N/A; N=30; Recruiting; Sponsor: Clearside Biomedical, Inc.; Not yet recruiting ➔ Recruiting

Enrollment open • Biosimilar • Diabetic Macular Edema • Ophthalmology • Retinal Vein Occlusion • Venous Thromboembolism

Suprachoroidal CLS-TA Plus Aflibercept Compared With Aflibercept Monotherapy for Diabetic Macular Edema (DME): Results of a Phase 2 Trial (ASRS 2019) - No abstract available.

Monotherapy • P2 data

Suprachoroidal Triamcinolone Acetonide for Retinal Vein Occlusion: Results of the Tanzanite Study. (PubMed, Ophthalmol Retina) - "Combination intravitreal aflibercept and suprachoroidal CLS-TA is well tolerated and significantly reduces the need for additional intravitreal aflibercept injections over a 3-month period in patients with RVO. Preliminary evidence suggests that combination therapy may sustain edema resolution and improve visual outcomes."

Journal

TOPAZ: Suprachoroidal Injection of Triamcinolone Acetonide With IVT Anti-VEGF in Subjects With Macular Edema Following RVO (clinicaltrials.gov) - P3; N=323; Terminated; Sponsor: Clearside Biomedical, Inc.; Trial completion date: Jun 2020 ➔ Dec 2018; Recruiting ➔ Terminated; Trial primary completion date: Aug 2019 ➔ Dec 2018; The early termination is due to the results obtained from the sister study, SAPPHIRE (CLS1003-301), which did not meet the 8-week primary efficacy endpoint.

Clinical • Combination therapy • Trial completion date • Trial primary completion date • Trial termination

SAPPHIRE: Suprachoroidal Injection of Triamcinolone Acetonide With IVT Aflibercept in Subjects With Macular Edema Following RVO (clinicaltrials.gov) - P3; N=460; Terminated; Sponsor: Clearside Biomedical, Inc.; Trial completion date: Jun 2019 ➔ Dec 2018; Active, not recruiting ➔ Terminated; Trial primary completion date: Jun 2019 ➔ Dec 2018; Primary, 8-week efficacy endpoint not achieved. No additional benefit for subjects receiving a corticosteroid together with an intravitreal anti-VEGF agent.

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