Gyroscope Therapeutics has been granted US Food and Drug Administration (FDA) clearance for its Orbit subretinal delivery system (Orbit SDS) for microinjection into the subretinal space.
The system is indicated for subretinal microinjection of balanced salt solution or BSS Plus at the back of the eye, designed to help prevent vitrectomy as well as eliminating the need to create a retinotomy to access the subretinal space.
“The FDA approval is an important component of developing gene therapies to help preserve sight,” said Khurem Farooq, Gyroscope CEO. “The Orbit [device] is exquisitely designed to target the subretinal space, with the aim of providing precise and consistent dosing.”
Farooq said Gyroscope will pursue licensing and collaboration arrangements to make Orbit SDS available to other companies developing cell and gene therapies for eye diseases.