At Glaukos our mission is to pioneer and lead the global glaucoma market with micro-scale injectable therapies that advance the existing glaucoma standard-of-care and enrich the lives and treatment alternatives for glaucoma patients worldwide. In June 2015, we completed an initial public offering and our shares are now traded on the New York Stock Exchange under the ticker symbol “GKOS”. This led to our business in Australia beginning in January 2016 and, since that time, the adoption of iStent inject in the management of glaucoma has continued to grow.

I have been fortunate enough to launch a number of innovative products over my 20 plus years in Ophthalmology. The continued feedback to myself and the team at Glaukos regarding the positive outcomes with iStent inject and the improved quality of life of many patients is truly appreciated.

In the U.S., our initial iStent® PMA application received approval in 3.5 years; the FDA completed its review and approval of our current application for iStent inject in less than 0.5 year.  The US recently launched iStent inject and U.S. surgeons will look to the experience that Australia has had with this innovative product.

The road to creating the MIGS market in Australia has had its own challenges, especially in regards to the MBS. Our submission for a new item number started back in April 2017 and we are now on the eve of a new item for cataract plus iStent inject.

In the 2018-19 Budget, the Government announced it had agreed to list on the MBS an item number for MIGS. This will be listed from 1 November 2018. The interim item number will remain in place until this process is complete.

During the MSAC submission, they did not support the MBS listing of a stand-alone MIGS procedure based on the available evidence at the time, however through the work of ASO, ANZGS, RANZCO and Glaucoma Australia the MSAC will reconsider listing of this service via a new submission which has been made. It is not uncommon for proposals for new services to require more than one submission; this submission is currently in review with the final MSAC Meeting in November.

http://www.health.gov.au/internet/main/publishing.nsf/Content/MC17-013891-MBD-rebate-for-MIGS-devices

If you have any comments, I would be pleased to receive them at gfawcett@glaukos.com. Thank you for your ongoing support and for making iStent inject the preferred approach to glaucoma management for many of your patients with mild-to-moderate primary open-angle glaucoma.

Kind regards,

GLENN FAWCETT
General Manager