Industry Insider is a timely chat with an ophthalmic industry thought leader.
Ophthalmology Management: DEXTENZA recently received a permanent J-code; why is that important for Ocular Therapeutix?
Antony Mattessich: Since DEXTENZA is a minimally invasive insert that can be inserted in either an office environment or hospital/ASC environment, the J-code is important as it allows for reimbursement across all types of service environments. Our plan is to move DEXTENZA into the office environment, where we expect to eventually have a number of products and indications.
Also helpful for this is our pass-through status for DEXTENZA, and combined with the J-code, that gives us a nice basis of coverage we want to grow even further.
OM: You are currently investigating DEXTENZA’s use to treat allergic conjunctivitis. Can you give us an update on that indication?
AM: We have performed a number of studies on DEXTENZA and allergic conjunctivitis, including a new one that is underway and almost fully enrolled. We hope that will be the final trial needed to apply for a supplemental NDA to extend DEXTENZA’s indication for that condition.
Virtually every timeline in all of our Phase 2 and Phase 3 trials for allergic conjunctivitis shows a vast majority of patients being statistically superior to placebo, and the majority of those were clinically meaningful and statistically superior.
We’re very confident we’ll be able to secure the indication and think it’s a good fit for DEXTENZA as it’s a better way of delivering a steroid than eyedrops.
OM: Ocular Therapeutix has several products in its pipeline, and some of the furthest along are those for glaucoma treatment. What can you tell us about those?
AM: We have two currently in development — OTX-TP, which is a travoprost insert, and OTX-TIC, a travoprost implant.
OTX-TP is a chronic glaucoma therapy designed to be placed in the canaliculus. We completed our first Phase 3 trial in May, and while the FDA has been encouraging of OTX-TP and wants to see further studies on it, we are putting a larger emphasis on OTX-TIC at this time.
While we only have data from a Phase 1 trial for OTX-TIC, that data is very exciting. In that trial, our first patients were injected with the intracameral OTX-TIC implant, and one of those patients is still going strong 16 months after injection with no need for rescue. The durability of the effect is astounding. The implant itself is designed to dissolve after 6 months, but we’re seeing the travoprost’s duration of effect go well beyond that time.
Despite OTX-TIC only being in Phase 1, the time to bring it to market is not that much different from OTX-TP. As we’re a small biotech company, we’ve decided that of the two, OTX-TIC and the intracameral delivery is the horse to bet on at the moment.
OM: Most of Ocular Therapeutix’s products are implants and inserts. Why focus on that type of treatment?
AM: The goal of Ocular Therapeutix is to deliver drugs locally, and the eye is one of the best places to do that; if you want to treat the eye, the worst thing you can do is treat the entire body to try and get to it.
There’s also the added benefit of compliance — since a lot of patients have trouble taking (or don’t take) medicine as they’re directed, implant and insert technology allows us to program the release of medicine to the patient. In coming years, I think the majority of drugs will be given that way. It’s the future of medicine, and that’s why I joined Ocular Therapeutix.
OM: Mr. Mattessich, you’ve held roles that have placed you in leadership roles in regions around the world. How does this global perspective help you today?
AM: Having worked in parts of the developing world, what I’ve seen is there’s no tradition of taking medication on a regular basis. That makes technology like inserts and implants even more important. For instance, if an ophthalmologist goes on a mission to the hinterlands of Nepal, their patients probably don’t have pharmacies or refrigeration for storing medicine; in those cases, a medicine such as DEXTENZA that moves beyond patient-administration is ideal. It’s the beginning of a whole new revolution in how medicine is administered, and DEXTENZA is the tip of that spear — if it’s successful, we can deliver on a broader promise of what this type of technology can do. OM