Bausch & Lomb
This article was originally published in The Gray Sheet
Executive Summary
December launch is planned for the firm's 25-gauge entry site alignment (ESA) device for use with the Millennium TSV25 system for transconjunctival standard vitrectomy, following 510(k) clearance of the component, announced Oct. 29. The system is used to correct retinal detachments, macular degeneration and diabetic eye diseases with incisions about half the size of standard incisions, according to B&L. Separately, the firm has agreed to license worldwide rights to Largo, Florida-based Unilens Corp.'s cast-molded, multifocal soft contact lens design. Under the agreement, B&L will develop, manufacture and market the device for frequent replacement, and pay a royalty ranging from 3-5% of sales. Distribution will begin within the next year, pending FDA approval...