Promising trial results for glaucoma device:
This article was originally published in Clinica
Executive Summary
Staar Surgical plans to submit its AQUA-FLOW collagen glaucoma drainage device to the US FDA a year earlier than originally intended, following promising preliminary results from a clinical study of the product. The company, which has completed the enrolment stage of the study, said early data showed that the control of intraocular pressure by the device was "excellent with minimal dependence on post-operative glaucoma drugs". Monrovia, California-based Staar plans to submit one-year data on the first 100 patients for US approval in the first quarter of 2000, rather than the two-year follow-up in the study protocol.