Work

First-in-Human Clinical Evaluation of a Novel Nonsurgical Suprachoroidal Delivery Approach for Triamcinolone in Diabetic Macular Edema

Year: 2026

Type: article

Abstract: Purpose: To evaluate the safety, tolerability, and effectiveness of the Everads Injector, a novel suprachoroidal drug delivery device, for administration of triamcinolone acetonide (TA) in patients with diabetic macular edema (DME). Design: A prospective, open-label pilot study. Subjects: Ten adult patients (10 eyes) with center-involved DME and inadequate response to prior anti-VEGF therapy. Methods: Each participant received a single suprachoroidal injection of 4 mg of TA in 100 μL using the injector. The device enables rapid, tangential delivery into the suprachoroidal space (SCS) by creating a channel from the sclera into the choroid via blunt dissection. Follow-up assessments were conducted on injection day and on days 3, 14, 28, and 42. Safety was assessed by adverse events monitoring, intraocular pressure (IOP) measurements, and comprehensive ocular examinations. Suprachoroidal delivery was confirmed through clinical evaluation and thermal imaging, verifying successful localization of TA within the SCS. Efficacy was measured by changes in central macular thickness and best-corrected visual acuity (BCVA). Main Outcome Measures: Safety, device performance, central macular thickness, and BCVA. Results: = 0.0039). Best-corrected visual acuity improved in most participants (8 eyes), with a mean gain of +11.4 letters on the ETDRS chart from baseline to visit 6. Conclusions: Suprachoroidal delivery of TA in patients with DME using the injector demonstrated favorable safety and tolerability. The procedure was well tolerated under topical anesthesia and performed successfully in an office-based setting. These findings support the feasibility of this delivery technology and highlight its potential clinical benefit in reducing macular edema and improving visual function. Further studies are warranted to confirm these results in larger, controlled trials. Financial Disclosures: Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

Source: Ophthalmology Science

DOI: 10.1016/j.xops.2026.101185

Authors: Yoreh Barak, Alexey Rapoport, Keren Mano-Tamir, Anastasiia Adakhovska, Quan Dong Nguyen

Institutions: Technion – Israel Institute of Technology, Rambam Health Care Campus, Stanford University

Language: English

Topic: Retinal Diseases and Treatments

Subfield: Ophthalmology

Field: Medicine

Domain: Health Sciences

SDG: Good health and well-being

Open Access status: gold

Estimated APC paid: $2,500