28 October 2020 - - UK-based gene therapy company Gyroscope Therapeutics Ltd., a clinical-stage retinal gene therapy company,

The first surgery using UK-based gene therapy company Gyroscope Therapeutics Ltd's proprietary Orbit Subretinal Delivery System (Orbit SDS) to deliver the company's investigational gene therapy, GT005, to a patient with geographic atrophy secondary to dry age-related macular degeneration has been conducted in the ongoing Phase I/II FOCUS trial, the company said.

The surgery was conducted in the United States by Jeffrey Heier, M.D., at Ophthalmic Consultants of Boston.

FOCUS [NCT03846193] is a Phase I/II open-label clinical trial that was initiated in January 2019. The trial is evaluating the safety and dose response of GT005 in people with GA secondary to dry AMD.

Three doses of GT005 are being evaluated in FOCUS. In the initial dose-escalation phase of FOCUS, which is now complete, patients were treated using a subretinal injection involving vitrectomy and retinotomy.

The trial has been expanded to include additional cohorts, including a dose-expansion cohort and two cohorts in which the Orbit SDS will be used to deliver GT005.

Gyroscope plans to enrol approximately 45 people who have a clinical diagnosis of GA secondary to dry AMD in FOCUS at sites in the United Kingdom and United States.

The Orbit SDS delivers a controlled volume beneath the retina, with the aim of providing precise and consistent dosing. The subretinal space is accessed by advancing a flexible cannula through the suprachoroidal space (the space between the sclera and the choroid).

A microneedle inside the cannula is then advanced to deliver a targeted dose beneath the retina.

The microinjection procedure is designed to avoid damaging the structure of the eye by eliminating the need for both a vitrectomy (a procedure that involves removing the vitreous the gel-like substance that fills the eye) and a retinotomy (a hole in the retina).

The Orbit SDS is 510(k) cleared for microinjection into the subretinal space at the back of the eye using saline solution (BSS or BSS PLUS).