– Vamikibart is the first non-steroid targeted therapy designed to address inflammation driving UME and may offer a potential new treatment option for patients –

– Vision improvements were seen in both pivotal studies, achieving statistical significance in MEERKAT and nominal significance in SANDCAT –

– The MEERKAT and SANDCAT trials are ongoing and the data will be discussed with health authorities globally –

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today results from two Phase III studies evaluating the efficacy and safety of two doses of investigational vamikibart (0.25 and 1 mg) compared with a sham procedure that mimics intravitreal (IVT) injections in people with uveitic macular edema (UME). UME is characterized by the buildup of fluid in the macula due to uveitis, an inflammatory condition of the eye, that can result in vision loss. Across both studies, the primary and secondary endpoint data support the potential for rapid improvements in vision and reductions in macular thickness (swelling in the back of the eye due to retinal fluid) with vamikibart treatment. The data were presented at the American Academy of Ophthalmology annual meeting (AAO 2025) in Orlando, FL.

“The totality of data from these pivotal vamikibart studies represent an important step towards addressing a clear unmet need for people with uveitic macular edema,” said Levi Garraway, M.D., Ph.D., Genentech’s chief medical officer and head of Global Product Development. “UME is a major cause of vision loss and blindness in people of working age. We look forward to discussing the data for this potential first-in-class treatment with regulatory authorities.”

“UME is most commonly treated with steroids that, when injected in the eye, are associated with significant side effects such as increased pressure in the eye, which can lead to glaucoma and cataract formation,” said study investigator Eric Suhler, M.D., MPH, Professor of Ophthalmology at the Casey Eye Institute, Oregon Health & Science University, Portland, OR. “These data seen across multiple endpoints in both Phase III studies, along with the overall low rate of treatment-related ocular adverse events, suggest that vamikibart could provide a clinically relevant, locally injectable non-steroid treatment option for people with UME.”

In both trials, a numerically higher proportion of patients treated with vamikibart gained vision, with primary endpoint data demonstrating statistically significant superiority over sham in MEERKAT, though not in SANDCAT. Consistently across both trials, key secondary endpoints showed rapid and clinically meaningful improvements in average change from baseline in best corrected visual acuity (BCVA), and average change from baseline in central subfield thickness (CST), a key measure of macular edema, supporting the overall efficacy profile of vamikibart.

The underlying variability of BCVA as an endpoint, along with variations in patient baseline characteristics and concomitant medications, may have influenced the differences in trial primary outcomes and further analyses are currently underway.

Vamikibart was generally well tolerated in both studies, with a low incidence of treatment-related ocular adverse events (AEs) and intraocular inflammation (IOI) events, and no events of retinal occlusive vasculitis. The most common AEs (≥5%) in either trial in patients receiving vamikibart were conjunctival hemorrhage and raised intraocular pressure.

Key data from the pivotal vamikibart Phase III MEERKAT and SANDCAT studies:

About the MEERKAT and SANDCAT studies

MEERKAT (NCT05642312) and SANDCAT (NCT05642325) are identical Phase III, global, parallel, multicenter, randomized, double-masked, sham comparator-controlled trials of intravitreal (IVT) vamikibart in uveitic macular edema (UME). In both trials, patients were randomized and received treatment every four weeks with either 0.25 mg vamikibart, 1 mg vamikibart or sham IVT injection, for up to 16 weeks. The primary endpoint of both Phase III trials was the proportion of participants with a 15 letter or more improvement from baseline in best corrected visual acuity (BCVA) at week 16. Key secondary endpoints included the average change from baseline in BCVA and CST at week 16. The safety of vamikibart was assessed through adverse events (AEs) such as treatment related ocular AEs, intraocular inflammation (IOI) and retinal occlusive vasculitis. The studies included participants with and without prior IVT treatment history and included patients with history of raised IOP and glaucoma.

About Uveitic Macular Edema (UME)

UME is characterized by the buildup of fluid in the macula due to uveitis, an inflammatory eye condition. Although rare compared to other eye diseases, UME has a disproportionate impact on vision loss and blindness globally. It is the leading cause of moderate and severe vision loss in people with uveitis, and the most frequent sight threatening complication in uveitis. Uveitis accounts for 10% to 20% of blindness in the United States and Europe, and up to 25% of blindness in the developing world. UME has a significant negative impact on people's quality of life, including physical and mental health, social functioning, and visual function for day-to-day activities such as driving and reading. Steroids, the current standard of care for UME, are associated with significant serious side effects such as increased pressure in the eye, glaucoma and cataracts, and have recognized efficacy limitations.

About Vamikibart

Vamikibart is an investigational monoclonal antibody that has been specifically engineered for IVT administration. It targets interleukin-6 (IL-6), a key cytokine in the inflammatory pathway in UME. In the Phase I DOVETAIL study, vamikibart provided rapid vision improvements and resolution of macular edema in people with UME. Vamikibart was also well tolerated, with no treatment-related serious adverse events reported. Based on the promising Phase I DOVETAIL data, Genentech initiated the two identical Phase III vamikibart studies MEERKAT and SANDCAT. Vamikibart is being investigated in retinal diseases with recognized inflammatory pathways, including in people with UME. Vamikibart has orphan drug designation in the United States and European Union.

About Genentech in Ophthalmology

Genentech is researching and developing new treatments for people living with a range of eye diseases that cause significant visual impairment and blindness, including wet age-related macular degeneration (AMD), diabetic macular edema (DME), diabetic retinopathy (DR), geographic atrophy (GA) and other retinal diseases, including rare and inherited conditions.

About Genentech

Founded nearly 50 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com.

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