Gyroscope Therapeutics Limited, a clinical-stage retinal gene therapy company, today announced that the first surgery using its proprietary OrbitTM Subretinal Delivery System (Orbit SDS) to deliver the company’s investigational gene therapy, GT005, to a patient with geographic atrophy (GA) secondary to dry age-related macular degeneration (AMD) has been conducted in the ongoing Phase I/II FOCUS trial. The surgery was conducted in the United States by Jeffrey Heier, M.D., at Ophthalmic Consultants of Boston.
“Dry AMD is one of the leading causes of vision loss globally and gene therapies hold tremendous promise for this disease. Delivering gene therapy directly to the site of disease through a subretinal injection is a proven approach; however, the current method requires a vitrectomy. The Orbit SDS is an innovative delivery system that could address some of the challenges surgeons and patients may experience with a vitrectomy. I have been involved with the development of the Orbit SDS for several years, and I am excited to see its introduction into subretinal delivery of what we hope to be an important therapeutic intervention,” said Dr. Heier, Co-President, Medical Director, Director of the Vitreoretinal Service, and Director of Retina Research at Ophthalmic Consultants of Boston.
“In 2019, Gyroscope merged with Orbit Biomedical to create the only retinal gene therapy company that combines all elements of drug development, a manufacturing platform, and surgical delivery capabilities. Our vision is to develop gene therapy beyond rare disease and we believe our proprietary Orbit SDS has the potential to help us achieve that. We look forward to further evaluating the Orbit SDS in our GT005 clinical programme,” said Khurem Farooq, Chief Executive Officer, Gyroscope.
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.
About Orbit SDS
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*).
About Dry AMD
Dry AMD is a leading cause of permanent vision loss in people over the age of 50, and is a devastating diagnosis. This gradual and permanent loss of central vision can severely impact a person’s daily life as they lose the ability to drive, read and even see the faces of loved ones. There are currently no approved treatments for dry AMD.
Gyroscope estimates that nearly 3.5 million people in the United States and EU5 European countries have GA, and that more than 100,000 people with GA have certain Complement Factor I (CFI) mutations that correlate with low CFI levels in the blood and a higher risk of developing AMD.