Refocus seeks US nod for presbyopia implant trials:
This article was originally published in Clinica
Executive Summary
Eye disorders medical device firm Refocus Group has filed an application with the US FDA to start phase II clinical trials of its implant system for treating presbyopia. Its scleral implants are implanted in the eye surgically, using a redesigned version of its scleral spacing procedure (SSP), which Refocus believes will simplify the surgical procedure and produce highly consistent outcomes. The Dallas, Texas company filed the clinical trial application together with its partner, CIBA Vision, the eye care unit of Novartis AG. CIBA Vision is seeking strategic alternatives for its surgical business unit.
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