Orbit subretinal delivery system receives 510(k) clearance
Gyroscope Therapeutics has received 510(k) clearance from the FDA for the Orbit subretinal delivery system, according to a press release.
The system is indicated for subretinal microinjection of balanced salt solution or BSS Plus at the back of the eye. The procedure would help prevent the need for vitrectomy and eliminate the need for retinotomy creation to access the subretinal space.
“The Orbit SDS is exquisitely designed to target the subretinal space, with the aim of providing precise and consistent dosing,” Khurem Farooq, CEO of Gyroscope Therapeutics, said in the release. “Our mission is to develop gene therapies and delivery systems to help preserve sight and fight the devastating impact of blindness.”
The company plans to seek licensing and collaboration agreements with other companies to use the Orbit SDS in gene and cell therapies for the eye.