Gyroscope Therapeutics announced that the FDA has granted 510(k) clearance for the Orbit Subretinal Delivery System (Orbit SDS). The Orbit SDS is 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. The approach also eliminates the need to create a retinotomy in order to access the subretinal space. This clearance is based on injection of Balanced Salt Solution (BSS) or BSS PLUS.*
“The Orbit SDS is exquisitely designed to target the subretinal space, with the aim of providing precise and consistent dosing,” Khurem Farooq, Chief Executive Officer of Gyroscope Therapeutics, said in a company news release. “Our mission is to develop gene therapies and delivery systems to help preserve sight and fight the devastating impact of blindness. The FDA clearance of the Orbit SDS is an important component in advancing towards this goal.”
The Orbit SDS is capable of delivering a controlled volume to a targeted subretinal delivery site. The Orbit SDS accesses the subretinal space via a suprachoroidal approach. This specially designed system enables cannulation of the suprachoroidal space with a flexible cannula. A microneedle inside the cannula is advanced into the subretinal space to enable targeted dose delivery.
The clearance authorizes the company to market and sell the Orbit SDS in the United States. In addition to developing the Orbit SDS for its own investigational medicines, Gyroscope plans to enter into licensing and collaboration arrangements involving the Orbit SDS with other companies who are developing gene and cell therapies to treat eye disease.