LONDON–(BUSINESS WIRE)–Gyroscope Therapeutics Limited, a clinical-stage retinal gene therapy company, today announced that the U.S. Food & Drug Administration (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, a procedure that involves removing the vitreous (the gel-like substance that fills the eye). The approach also eliminates the need to create a retinotomy (a hole in the retina) 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,” said Khurem Farooq, Chief Executive Officer. “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 authorises 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.
Gyroscope Therapeutics: Vision for Life
Gyroscope Therapeutics is a clinical-stage retinal gene therapy company developing and delivering gene therapy beyond rare disease to treat a leading cause of blindness, dry age-related macular degeneration. Our lead investigational gene therapy, GT005, is a one-time therapy delivered under the retina. GT005 is designed to restore balance to an overactive complement system by increasing production of the Complement Factor I protein. GT005 is currently being evaluated in a Phase I/II clinical trial called FOCUS and a Phase II clinical trial called EXPLORE.
Syncona Ltd, our lead investor, helped us create the only retinal gene therapy company to combine discovery, research, drug development, a manufacturing platform and surgical delivery capabilities. Headquartered in London with locations in Philadelphia and San Francisco, our mission is to preserve sight and fight the devastating impact of blindness. For more information visit: www.gyroscopetx.com and follow us on Twitter (@GyroscopeTx) and on LinkedIn.
*BSS PLUS is a registered trademark of Alcon Laboratories, Inc.