Staar Seeking Expedited Approval For Aqua-Flow Glaucoma Drainage Device
This article was originally published in The Gray Sheet
Anticipated expedited review and subsequent FDA approval of Staar Surgical's Aqua-Flow collagen glaucoma drainage device would make it available for U.S. launch by the end of the year or early 2001, the firm projected during a March 30 teleconference.
You may also be interested in...
Financial restructuring plan will involve one-time charges of $15-17 mil. in the second quarter, the firm says. Included are the "write-off or restructuring of under-performing subsidiaries, write-off of old or unnecessary patents and write-off of inventory which the company believes may become obsolete or does not fit the future strategy," as well as a write-off of investments in the Japanese Canon/Staar joint venture and laser centers. Combined with additional cost savings measures, the changes will result in annual savings of $0.32 to $0.45 per share, Staar says. However, added costs of up to $1.5 mil., or $0.10 per share, are expected to prepare for marketing of the Aqua-Flow collagen glaucoma drainage device, for which FDA approval is anticipated in the first quarter of 2001 (1"The Gray Sheet" April 3, p. 20). First-quarter 2000 results announced May 11 included a 4.7% decline in sales to $14.1 mil. Net income was $271,000 compared to $673,000 for the first quarter last year. "The board of directors and management goal is to be a $250 mil. company within the next three to five years," commented chief operating officer William Huddleston
Data show Opdivo/Cabometyx combo bests Sutent for overall and progression-free survival and response endpoints in first-line RCC. Exelixis CEO says comparison to Sutent is standard control and allows better comparison to other combo regimens.