Update: The FDA postponed the panel meeting owing to bad weather conditions. No new date has yet been set.
It is traditional to have a date for Valentine’s day, and Staar Surgical has one with the ophthalmic devices panel of the FDA’s medical devices advisory committee. The panel will review Staar’s Visian toric implantable Collamer lens (TICL), designed to be implanted in a patient’s eye to treat myopic astigmatism.
The device’s ability to treat astigmatism as well as short sight ought to weigh with the panel as there is pent-up demand in the market thanks to patients who would like an implanted lens but need a toric version; that is, one that can treat astigmatism. If the adcom goes Staar’s way and is followed by FDA approval, sales of the lens could almost double the company’s US revenue base.
Unlike other implanted toric lenses such as Bausch + Lomb’s Trulign product, which won over the panel in April and secured premarket approval a month later, the Visian TICL is not designed to replace the native lens (Panel backing for lens rewards Bausch + Lomb’s focus on devices, April 9, 2013). Instead, it is placed in front of the lens, just behind the iris.
Made of Collamer, a collagen-based material developed by Staar, the implant is intended to remain in place permanently, but can be removed if necessary.
The Visian TICL does not require excision of the patient’s own lens because it is a therapy for short sight and astigmatism, where the Bausch + Lomb product was intended for use in patients who had to undergo cataract surgery. This in turn means that implantation of Staar’s lens is elective: it competes not with Trulign and related products but with laser eye surgery and, less directly, contact lenses and spectacles.
US approval has taken a long time, having been put on "integrity hold" in August 2007 for almost two years. Integrity hold is invoked by the agency when it finds that clinical data are “questionable”. To get the hold lifted, Staar had to perform an independent audit of all data used in the application – a PMA supplement to the Visian ICL which the FDA approved in December 2005 – a review of the clinical sites involved in data collection, and a systems audit of the company.
It is, at least, approaching the market at a good time. Sectors with a large elective component, such as ophthalmology and orthopaedics, and are seeing a notable upswing as employment rates in the US and elsewhere improve: more people have healthcare insurance provided by their employers and are hence free to opt for procedures they may otherwise have been forced to put off.
Matthew O'Brien, an analyst at William Blair & Co, writes that if the panel votes in favour of the product FDA approval could come 6-12 months later, with launch following swiftly. Staar’s management have previously stated that having a toric product on the US market could add more than $5m in annual revenue. With US sales currently around $6m each year, the firm stands to gain hugely.
This may not, however, move the stock enormously. Mr O’Brien points out that shares of Staar “trade at one of the highest valuations in medical technology” – 5.5 times the analysts’ 2014 revenue target of $82m – “which leads us to believe that approval is somewhat baked into the stock”. Even so, approval will be a victory for the Monrovia, California company.