tivozanib eye drops (KHK4951) / Kyowa Kirin - LARVOL DELTA

Study to Assess the Efficacy & Safety of KHK4951 in Patients With Neovascular Age-Related Macular Degeneration (clinicaltrials.gov) - P2 | N=180 | Recruiting | Sponsor: Kyowa Kirin Co., Ltd. | Trial completion date: Dec 2025 ➔ Sep 2026 | Trial primary completion date: Nov 2025 ➔ Aug 2026

Trial completion date • Trial primary completion date • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Study to Assess the Efficacy & Safety of KHK4951 in Patients With Diabetic Macular Edema (clinicaltrials.gov) - P2 | N=150 | Recruiting | Sponsor: Kyowa Kirin Co., Ltd. | Trial completion date: Dec 2025 ➔ Sep 2026 | Trial primary completion date: Nov 2025 ➔ Aug 2026

Trial completion date • Trial primary completion date • Diabetic Macular Edema • Ophthalmology

Exploring new horizons in neovascular age-related macular degeneration: novel mechanisms of action and future therapeutic avenues. (PubMed, Eye (Lond)) - "Gene therapies, including RGX-314 and Ixo-vec, express an anti-VEGF protein, and 4D-150, expresses an anti-VEGF protein and a VEGF-C inhibitory miRNA. Anti-VEGF associated therapeutics include OPT-302, targeting VEGF-C and VEGF-D, BI 836880, which inhibits VEGF-A and Ang-2 activity, and Tarcocimab tedromer, inhibiting all VEGF-A isoforms. Agents with novel mechanisms of action include UBX1325, which inhibits an anti-apoptotic protein, Restoret (EYE103), a Wnt agonist, and the tyrosine kinase inhibitors, EYP-1901, OTX-TKI, CLS-AX, and KHK4951."

Journal • Review • Age-related Macular Degeneration • Gene Therapies • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration • VEGFC • VEGFD

Kyowa Kirin Announces Acceptance of Abstract for Presentation at the Association for Research in Vision and Ophthalmology Annual Meeting 2024 (PRNewswire) - "Kyowa Kirin...announced that pre-clinical data of tivozanib (KHK-4951), an investigational product, assessing the ocular pharmacokinetics of a novel tivozanib eye drop for neovascular age-related macular degeneration (nAMD), will be presented at the upcoming Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting to be held in Seattle, Washington from May 5-9, 2024."

Preclinical • Wet Age-related Macular Degeneration

Phase 2 Study to Assess the Efficacy & Safety of KHK4951 in Patients With Diabetic Macular Edema (clinicaltrials.gov) - P2 | N=150 | Recruiting | Sponsor: Kyowa Kirin, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Diabetic Macular Edema • Ophthalmology

Phase 2 Study to Assess the Efficacy & Safety of KHK4951 in Patients With Neovascular Age-Related Macular Degeneration (clinicaltrials.gov) - P2 | N=180 | Recruiting | Sponsor: Kyowa Kirin, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Kyowa Kirin Announces First Patient Enrolled in the Phase 2 Clinical Trial Evaluating Tivozanib Eye Drops in Patients with Diabetic Macular Edema (PRNewswire) - "Kyowa Kirin...announced the enrollment of the first patient in a Phase 2 clinical trial, multi-center, randomized, double-masked, parallel group study of tivozanib eye drops (KHK4951). This study investigates the efficacy and safety of KHK4951 in patients with diabetic macular edema (DME)....The Phase 2 study will be recruiting 150 patients with DME across the US, Japan, Australia and South Korea. The primary outcome measure is reduction of 15 or more letters from baseline in BCVA (Best Corrected Visual Acuity) as measured by the ETDRS visual acuity chart....A separate Phase 2 study to evaluate KHK4951 in patients with neovascular(wet) age-related macular degeneration(nAMD) is also being initiated. This study is currently recruiting patients."

Trial status • Diabetic Macular Edema • Wet Age-related Macular Degeneration

A Phase 2 Study to Assess the Efficacy and Safety of KHK4951 in Patients With Neovascular Age-Related Macular Degeneration (clinicaltrials.gov) - P2 | N=180 | Not yet recruiting | Sponsor: Kyowa Kirin, Inc.

New P2 trial • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

A Phase 2 Study to Assess the Efficacy and Safety of KHK4951 in Patients With Diabetic Macular Edema (clinicaltrials.gov) - P2 | N=150 | Not yet recruiting | Sponsor: Kyowa Kirin, Inc.

New P2 trial • Diabetic Macular Edema • Ophthalmology

A Safety Study of KHK4951 in Healthy Volunteers and Patients With Wet Age-Related Macular Degeneration (clinicaltrials.gov) - P1 | N=116 | Terminated | Sponsor: Kyowa Kirin Co., Ltd. | Trial completion date: Dec 2022 ➔ Aug 2022 | Recruiting ➔ Terminated; The Sponsor judged that the objectives of this Phase 1 study were satisfied, and the study was terminated after the completion of Cohort 3 Step 3.

Trial completion date • Trial termination • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

A Safety Study of KHK4951 in Healthy Volunteers and Patients With Wet Age-Related Macular Degeneration (clinicaltrials.gov) - P1; N=128; Recruiting; Sponsor: Kyowa Kirin Co., Ltd.; N=96 ➔ 128; Trial completion date: Feb 2022 ➔ Dec 2022; Trial primary completion date: Feb 2022 ➔ Sep 2022

Clinical • Enrollment change • Trial completion date • Trial primary completion date • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

A Safety Study of KHK4951 in Healthy Volunteers and Patients With Wet Age-Related Macular Degeneration (clinicaltrials.gov) - P1; N=96; Recruiting; Sponsor: Kyowa Kirin Co., Ltd.

Clinical • New P1 trial • Age-related Macular Degeneration • Complement-mediated Rare Disorders • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration