Transcend’s Move Toward PMA

Well, the MIGs market could get a little more crowded.

This week, Transcend Medical announced it had submitted the final module of its PMA application for the CyPass Micro-Stent, an implant designed to reduce intraocular pressure (IOP) in patients with primary open-angle glaucoma.

FDA approval, which likely won’t come until next year at the earlier, would pit Transcend against publicly held Glaukos Corp., which has had the market to itself.

With Glaukos’ IPO and Allergan’s acquisition of early-stage AqueSys, Transcend’s filing continues to make the MIGS space one of the more exciting fields in ophthalmology.

Transcend CEO and President Brian Walsh took a few minutes to answer some emailed questions posed by OIS’ Eye On Innovation.

Congratulations on the PMA filing. We spoke with your CMO Sean Ianchulev, MD, a few months back about the size of the trial and the length of the follow up. No doubt this trial was daunting but what benefits will this depth of data provide?

As Dr. Ianchulev mentioned, the COMPASS study is both double the size and follow-up of the first-generation iStent study, and the first study to complete with terminal washout of glaucoma medications at the 12- and 24-month endpoints. This has given us a very clear picture of the performance profile of the CyPass Micro-Stent plus cataract surgery as compared to cataract surgery alone, and the benefits with respect to IOP-lowering out to two years. This size of the trials has also given us high confidence in the safety profile of a MIGS device in the supraciliary space – the first ab interno micro-stent focused on this aqueous outflow pathway.

With the filing of the PMA, what’s next? Advisory panel? If so what’s the timing for a panel and, hopefully, the green light.

Based on usual review times, if a panel is required, we will expect to present in front of the advisory panel some time mid-next year. While I can’t comment on how the review will go, what I can say is that we have worked very closely with FDA in optimizing the design of our COMPASS pivotal study to be one of the most scientifically rigorous glaucoma device trials to date, as described above.

If approved, you’ll be entering a market Glaukos has had all to itself for a few years. How does being a second mover help? What are the challenges?

Being a second mover has a distinct advantage in that today, both glaucoma specialists and comprehensive cataract surgeons understand where MIGS fit as an option for their mild-to-moderate glaucoma patients undergoing cataract surgeon. They are comfortable providing a surgical solution for these patients, which is a paradigm shift. So then the question becomes, as an ophthalmic surgeon, why should you consider a new procedure? We believe there are important advantages to the CyPass Micro-Stent procedure that will be very compelling for ophthalmologists and glau-coma patient.

Let’s talk fund-raising. According to our partner Pitchbook, you’ve raised close to $100 mil-lion in private capital. How much more do you think you’ll need to stage a launch? Any fund-raising plans?

For the US market launch, we will bring on a best-in-class ophthalmic device commercialization team, which of course will take additional capital. While we are in the planning stages of that process and can’t comment on specifics – we are prepared to take this product all the way across the finish line, as we strongly believe in the therapeutic potential of the CyPass technology for glaucoma patients.

You’ve stated that you have pharma and medical device companies as investors. Are there any options to acquire built into those investments? If not, any partnerships likely on com-mercialization?

While I can’t comment on the specifics of any partnerships, what I can say is that we have no binding obligations at this time. Our investment syndicate is very committed to this technology and as mentioned above, is prepared to support it through to commercialization.

Finally, Transcend and Glaukos already have faced off in court, with the courts ruling in favor of Transcend. A bench trial is presently scheduled for November 2015 to adjudicate the allegation of inequitable conduct against Glaukos. Could you offer any insights?

We are very pleased with the progress we have made to date in our litigation against Glaukos and with the Court’s recent rulings. Since the case is still pending, it would not be appropriate for me to comment further at this point. (After this article was published, Transcend and Glaukos announced a settlement of the dispute.)