Suprachoroidal Aqueous Outflow Biostent Successful in Initial Human Study

Microbypass stents have established their place in glaucoma care since the first device was approved in 2012, yet several studies describe the need to address long-term challenges of fibrotic response around implants that may be prompted during wound healing or by foreign bodies, potentially leading to reduced aqueous drainage. A natural tissue stent may alleviate this problem. The first in vivo human trial with a new suprachoroidal biostent placed to support cyclodialysis was presented at the American Academy of Ophthalmology 2022 meeting in Chicago, held September 30 to October 3.

This investigation included 10 eyes of 10 consecutive patients with open-angle glaucoma (OAG) and cataract who underwent combined phacoemulsification and ab interno cyclodialysis. The passage between anterior chamber and suprachoroidal space was stabilized with a biostent of micro-trephined tissue from a scleral donor. Implantation was successful for all participants and no adverse events affecting vision were reported.

Mean preoperative intraocular pressure (IOP) of 24.2±6.9 mm Hg was reduced to 14.6±3.2 mm Hg at 1 year after surgery, according to the poster, representing a 40% decrease. Further, 80% of eyes reached 20% or greater decline in IOP after 12 months.

Patients were taking an average of 1.3±0.8 ocular hypotensive drugs at baseline. This medication burden decreased by 62% by the end of the study period.

“This first-in-human study of an aqueous drainage suprachoroidal bioimplant demonstrated surgical feasibility, safety and robust IOP-lowering effect,” according to the investigators.

Disclosures: The presenting study author has declared affiliations with the biotech, medical device, and pharmaceutical industries. Please see the original study for a full list of disclosures.