Everads Therapy presented on first-in-human study of the Everads Injector for suprachoroidal administration at EURETINA 2024

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Everads Therapy presented initial clinical results from a first-in-human study of the Everads Injector for suprachoroidal administration at the 24th EURETINA Congress in Barcelona held in September of 2024. The data from this presentation was the results of an open-label safety and performance study (NCT06314217) that uses the injector for administration of a triamcinolone acetonide suspension to treat of patients with diabetic macular edema (DME).¹

According to the company, Everads suprachoroidal delivery technology is designed to enable safe and effective in-office delivery of therapies to the choroidal and retinal tissues via the suprachoroidal space.¹ As demonstrated by Barak Y et al² and Eclov R et al³ in poster presentations at ARVO 2024, the Everads technology is differentiated by its ability to deliver therapy rapidly throughout the posterior pole, enabling circumferential transduction past the posterior pole to the macular RPE seen using 2 AAV serotypes in non-human primates.

Along with these previously shared results, data showing the ability of Everads' technology to enable rapid distribution to the macular region in non-human primate models was the focus of a publication in Translational Vision Science and Technology (TVST)⁴.

Yoreh Barak, MD, Head of Retina at the Department of Ophthalmology at Rambam Medical Center is the study's principal investigator. In the company’s press release¹ on this news, he stated, "The data reported today confirm the effectivity, ease of use and tolerability of the Everads Injector for suprachoroidal delivery. The ability for an individual physician in an office setting to deliver drug non-surgically via this promising administration route could lead to the development of more effective and less invasive treatments for posterior segment eye diseases."

Results from the pre-specified first cohort of patients were cleared by the Ministry of Health, and the company is now recruiting patients into its next cohort. Full results of the clinical trial are expected to be presented at an upcoming medical congress.¹

Moshe Weinstein, Everads' CEO, also weighed in on the presentation of data, saying, "We are excited to report promising results that clearly validate our technology in a clinical setting. These data will be used to support the clinical trial applications of our license partners and our internal programs, enabling suprachoroidal delivery of next-generation treatments for retinal diseases."¹

The presentation, entitled "A Novel Suprachoroidal Delivery Technology: Results from a First in Human Pilot Study – Cohort 1," was an e-poster during the 2024 EURETINA congress.

Reference:

1. Everads Presents Clinical Data from First-in-Human Trial of Suprachoroidal Delivery Technology at EURETINA. Everads Therapy. September 19, 2024. Accessed October 8, 2024. https://www.prnewswire.com/il/news-releases/everads-presents-clinical-data-from-first-in-human-trial-of-suprachoroidal-delivery-technology-at-euretina-302252984.html

2. Yoreh Barak, Matthew Lawrence, Lindsay T Marjoram, Stephanie M Fogerson, Miriam Mangelus, Keren Mano Tamir; In vivo Assessment of Everads Novel Suprachoroidal Injector for Delivery of AAV5-GFP to the Macular RPE in Non-Human Primates. Invest. Ophthalmol. Vis. Sci. 2024;65(7):3985.

3. Rachel Eclov, Michael Engles, Pilar Prentiss, Will Quinn, Dawn Fellner, Hagay Drori, Rob Damitz, Jiewu Liu, Ashlyn Bassiri, Yoreh Barak, Michele Stone; Evaluation of AAV2 biodistribution after suprachoroidal injection in NHPs using a novel suprachoroidal delivery device system. Invest. Ophthalmol. Vis. Sci. 2024;65(7):5325.

4. Sher I, Goldberg Z, Bubis E, Barak Y, Rotenstreich Y. Suprachoroidal delivery of bevacizumab in rabbit in vivo eyes: Rapid distribution throughout the posterior segment. European Journal of Pharmaceutics and Biopharmaceutics: Official Journal of Arbeitsgemeinschaft Fur Pharmazeutische Verfahrenstechnik eV. 2021;169:200-210. doi:https://doi.org/10.1016/j.ejpb.2021.10.003