Transcend Medical, which was acquired by Alcon in February this year, has developed CyPass micro invasive glaucoma surgical (MIGS) device to treat patients with mild to moderate primary open-angle glaucoma in conjunction with cataract surgery.
The approval was granted for CyPass device based on the results of Compass study, which followed around 500 mild to moderate glaucoma patients undergoing cataract surgery.
According to Novartis, the CyPass device study met primary effectiveness endpoint with 73% in the group achieving a statistically significant decrease in intraocular pressure (IOP).
The MIGS device will be implanted just below the surface of the eye in conjunction with cataract surgery.
CyPass will treat less severe glaucoma by enhancing part of the natural drainage pathways of the eye with minimal tissue disruption. It enables the excess fluid in the eye to drain with the goal of reducing IOP levels.
Alcon CEO Mike Ball said: "We are pleased by the FDA's decision to approve our CyPass Micro-Stent which establishes Alcon's presence in this emerging surgical category to treat mild to moderate glaucoma.
"It will provide a less invasive means of lowering IOP than traditional glaucoma surgery, with the goal of lowering the patient's dependence on topical glaucoma medication.”
