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Roche presents new phase III pivotal data for vamikibart in uveitic macular edema (UME), a serious cause of vision loss
Globenewswire· 2025-10-17 20:20
Core Insights - Roche announced positive results from two phase III studies of vamikibart, an investigational treatment for uveitic macular edema (UME), showing potential for rapid vision improvement and reduction in macular thickness [1][2][7] Study Results - The studies, MEERKAT and SANDCAT, demonstrated statistically significant improvements in best corrected visual acuity (BCVA) in the MEERKAT trial, with a 36.9% improvement in the 1 mg vamikibart group compared to sham [5] - In the SANDCAT trial, a 20.7% improvement was observed in the 0.25 mg vamikibart group, although it did not reach statistical significance [5] - Key secondary endpoints showed rapid improvements in average change from baseline in BCVA and central subfield thickness (CST), supporting vamikibart's efficacy [2][5] Safety Profile - Vamikibart was generally well tolerated, with low incidence of treatment-related ocular adverse events and no cases of retinal occlusive vasculitis reported [4][9] - The most common adverse events included conjunctival hemorrhage and raised intraocular pressure [4] Treatment Context - UME is a significant cause of vision loss and blindness, particularly in working-age individuals, and current treatments with steroids have notable side effects [2][10] - Vamikibart represents a potential first-in-class non-steroid treatment option targeting interleukin-6 (IL-6), a key cytokine in UME's inflammatory pathway [11][12] Future Directions - Roche plans to discuss the study data with regulatory authorities globally, indicating a pathway towards potential approval and market introduction of vamikibart [2][7]
UNITY Biotechnology Appoints Industry Leader and Ophthalmology Expert Yehia Hashad, M.D., to the Board of Directors
Globenewswire· 2025-03-10 12:00
Core Insights - UNITY Biotechnology, Inc. has appointed Dr. Yehia Hashad to its board of directors and science committee, enhancing its leadership in ophthalmology as it prepares for the Phase 2b ASPIRE trial data readout for UBX1325 [1][2] Company Overview - UNITY is focused on developing therapeutics aimed at slowing, halting, or reversing diseases associated with aging, particularly in ophthalmologic and neurologic fields [4] Leadership and Expertise - Dr. Hashad brings over 25 years of experience in clinical and commercial drug development, having previously held leadership roles at Bausch + Lomb and Allergan Aesthetics, overseeing numerous pharmaceutical programs [2][3] - His expertise in ophthalmology is expected to be crucial for advancing UBX1325, a treatment for diabetic macular edema [2][3] Strategic Goals - The company aims to leverage Dr. Hashad's insights to optimize its strategy for UBX1325 and to develop a robust pipeline of future products targeting retinal diseases [2][3]