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# Gyroscope Therapeutics Orbit Subretinal Delivery Cleared
- URL: https://www.fdaweb.com/gyroscope-therapeutics-orbit-subretinal-delivery-cleared/
- Published: 2020-08-25T12:00:00.000Z
- Updated: 2026-09-14T16:26:18.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5147512

FDA has cleared a Gyroscope Therapeutics 510(k) for the Orbit Subretinal Delivery System, indicated for microinjection into the subretinal space at the back of the eye. The microinjection procedure is designed to avoid damaging the structure of the eye by preventing the need for a vitrectomy, a procedure that involves removing the vitreous (the gel-like substance that fills the eye), the company says. The approach also eliminates the need to create a retinotomy (a hole in the retina) in order to access the subretinal space. The clearance covers the injection of Alcon’s balanced salt solution.

The company says Orbit is capable of delivering a controlled volume to a targeted subretinal delivery site. It accesses the subretinal space via a suprachoroidal approach to enable cannulation with a flexible cannula. A microneedle inside the cannula is advanced into the subretinal space to enable targeted dose delivery, it says.