Kyowa Kirin Co., Ltd. (TSE: 4151) today announced that data from the pre-clinical pharmacokinetics & efficacy study comparing ocular tissue distribution after ocular instillation of tivozanib eye drops 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.
PRINCETON, N.J. and TOKYO, May 8, 2024 /PRNewswire/ -- Kyowa Kirin Co., Ltd. (TSE: 4151) today announced that data from the pre-clinical pharmacokinetics & efficacy study comparing ocular tissue distribution after ocular instillation of tivozanib eye drops 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. Age-related macular degeneration (AMD) is a leading cause of severe vision loss for people aged 50 years and older in developed countries worldwide, with a profound impact on the quality of life of affected individuals. With the increase in life expectancy, the number of reported cases of AMD will increase, continuing to add to the substantial burden already on patients, caretakers, and on health care system. Neovascular (wet) AMD (nAMD) is characterized by abrupt central vision loss caused by abnormal blood vessel growth and leakage in the macular area, the part of the retina that is responsible for everyday activities such as reading, driving, and writing. These vessels are fragile, leak fluid, can easily break and cause bleeding. nAMD accounts for roughly 10% of all AMD cases, but almost 90% of AMD-related central vision loss. “Today, we are excited to present the preclinical data of the nano-crystalized tivozanib after application as eye drops which set the stage for our completed phase 1 clinical trial in Japanese patients with neovascular age-related macular degeneration,” said Judit Baffi, lead Clinical Science Ophthalmologist at Kyowa Kirin. “We look forward to sharing more data about this novel investigational agent as they become available and highlighting its different route of delivery in nAMD which has the potential of lessening the burden for patients and treatment teams in this vision threatening disease.” Separate phase 2 clinical trial, multi-center, randomized, double-masked, parallel group studies of tivozanib eye drops (KHK4951) aimed to investigate the efficacy and safety of KHK4951 in patients with nAMD and diabetic macular edema (DME) are both currently recruiting patients. Abstract Title: Pre-clinical ocular pharmacokinetics and efficacy of a novel Tivozanib eye drop for neovascular age-related macular degeneration In this pre-clinical study, nano-crystalized formulations of tivozanib (nTivo) was ocularly instilled to rabbits and monkeys, and ocular pharmacokinetics and efficacy were evaluated. In pigmented rabbits, nTivo eye drops showed up to 9.5 times higher drug delivery efficiency to the retina/choroid compared to microcrystal formulations. Repeated ocular installation of nTivo eye drops increased exposure in the retina/choroid compared to single ocular installation in pigmented rabbits. The elimination half-life (t1/2) of tivozanib was longer in the retina/choroid compared to serum. Pigmented rabbits showed higher exposure and longer t1/2 in the retina/choroid compared to albino rabbits. In laser-induced choroidal neovascularization model in monkeys, nTivo eye drops decreased neovascularization lesion area and showed increased drug concentrations in the choroid and retina with higher dosing frequency. In vivo data suggest that nTivo eye drops could be a potential therapeutic agent for treating posterior eye diseases. The accumulation and sustained exposure to tivozanib in the choroid and retina may be related to melanin-binding properties and nano-crystallized formulation of tivozanib. About tivozanib About Kyowa Kirin View original content to download multimedia:https://www.prnewswire.com/news-releases/kyowa-kirin-will-present-pre-clinical-data-at-the-association-for-research-in-vision-and-ophthalmology-annual-meeting-2024-302140122.html SOURCE Kyowa Kirin | ||
Company Codes: Tokyo:4151, OTC-PINK:KYKOY |