This roundtable discussion series about sustained-release drug delivery for glaucoma includes Steven R. Sarkisian, Jr., MD, founder and CEO of Oklahoma Eye Surgeons, PLLC, in Oklahoma City, Oklahoma; Jacob Brubaker, MD, from Sacramento Eye Consultants in Sacramento, California; and E. Randy Craven, MD, FACS, Chief of Wilmer Eye Institute, Bethesda Location, Vice Chair for Wilmer Network of Locations, and an associate professor at Johns Hopkins University in Baltimore, Maryland. The fourth part of this series addresses potential barriers to adoption as well as where sustained-release glaucoma therapies will fit into the treatment paradigm.
Dr. Sarkisian: What do you think are going to be the main barriers to adoption for sustained-release glaucoma therapies? Do you think it’s going to be cost? Do you think it’s going to be a part D addendum?
Dr. Craven: I think it’s going to be the same as getting argon laser trabeculoplasty and selective laser trabeculoplasty (SLT) widely adopted. It’s a new paradigm, and surgeons worry about anything that might be invasive. That’s normal. There will be those who are the big adopters of it, because they think it’s easy to do and they like it, but I think in general, invasive procedures are adopted slowly. It took the iStent (Glaukos) a long time to take off.
Dr. Sarkisian: And even with it being in the preferred practice patterns that SLT is first-line therapy, we’re only recently seeing perhaps the majority of surgeons agreeing that yes, that is good first-line therapy and I’m doing that. So hopefully that groundwork has been laid. I foresee all of these things being done in the office, including the iDose, although I’m sure there will be a facility fee, and so it depends on the doctor’s situation what they’re going to do — whether they’d do it in their own ASC or whether they’d do it in a minor procedure room in their office. That’s going to be very interesting.
I certainly think that this will be a great treatment for refractory glaucomas as well. Really, any time you would use a medicine, this would be appropriate. Are there any other thoughts about what patients would make good candidates?
Dr. Brubaker: As it rolls out, yes, there will be slow adoption because of cost, reimbursement, and surgeons figuring out how to incorporate it into the paradigm. It’s also possible that we will use it for patients who are noncompliant, are admitting that they’re noncompliant, don’t want to take drops, or are intolerant to eye drops and have surface issues. I think it will start with those patients and will hopefully expand into more mainstream use from there.
Dr. Craven: There are very few people that go all in with invasive procedures. They want to make sure that it’s okay in their hands and they’re comfortable with it.
Dr. Sarkisian: Let’s do a speed round. Say you have a 60-year-old patient newly diagnosed with glaucoma, with pressures of 30, mild disease, and open angles. For their first-line treatment, would you do SLT, or would you consider a sustained release?
Dr. Brubaker: I would still start with SLT.
Dr. Craven: I would start with SLT, also.
Dr. Sarkisian: I probably would as well. So let’s say you do SLT and the pressure goes to 25, and you still think the patient needs a pressure at least in the high teens. Is that when you’d go to sustained release?
Dr. Brubaker: Yes, absolutely.
Dr. Sarkisian: If they’re pseudophakic might you be more enthusiastic about going to sustained release?
Dr. Brubaker: I think I’d be more enthusiastic about putting something in the eye in that case, as far as having more space. An off-label use would be to put a Bimatoprost SR in the sulcus and keep it away from the cornea. That opens up a few more options as opposed to a patient who is phakic, maybe moving more toward cataracts; at that point you could do MIGS and iDose at the same time.
Dr. Sarkisian: If a thousand patients in the phase 3 iDose study followed for 3 years show no increase in the rate of cataract, would that change your thoughts? Obviously, not all thousand are going to have the implant and not all thousand are going to be phakic, but hundreds of patients are phakic. If there’s zero incidence of iDose-related cataract formation, would that change your metrics there?
Dr. Brubaker: I think so. I think if it lasts closer to one year, then obviously I think that would be something that I would go for. It just depends on what the data show and the longevity.
Dr. Sarkisian: Any other thoughts about the topic of sustained-release glaucoma therapies that you think people really ought to know and be prepared for?
Dr. Craven: I will say that the basic science researchers’ interest in and work on sustained delivery and putting drugs in nanothreads is incredible. You can do so much with nanoparticle technology that this is just the start. Maybe everything we have will have drugs tied into it. There are antibiotic-eluting sutures in development.1 Potentially we could have IOLs with a coating that delivers a nonsteroidal. I think this is just the beginning.
Dr. Sarkisian: Fantastic. I agree. This is going to be such a significant change for every practitioner who takes care of glaucoma patients. And I think that the glaucoma practice is going to start to resemble a retina practice in some ways; we’re going to be doing so many injections that I think we’re going to be having injection clinics just like retina specialists do. These are exciting times, indeed. Gentlemen, I want to thank you so much for taking the time.
Editor’s note: Dr. Sarkisian reports consultancy to, advisory board membership with, speaker’s fees from, and grant support from Alcon; consultancy to, advisory board membership with, and speaker’s fees from Allergan and Bausch + Lomb; consultancy to and advisory board membership with Beaver-Visitec International, Katena Products, New World Medical, Omeros, and Santen; consultancy to, advisory board membership with, equity ownership with, and grant support from Sight Sciences; and consultancy to, advisory board membership with, and grant support from Glaukos. Dr. Brubaker reports consultancy to Glaukos and Allergan. Dr. Craven reports consultancy to and advisory board membership with Aerie Pharmaceuticals, Alcon, Allergan, Aqueous Biomedical, Ivantis, Santen, and W.L. Gore.
Reference
- Kashiwabuchi F, Parikh KS, Omiadze R, et al. Development of absorbable, antibiotic-eluting sutures for ophthalmic surgery. Transl Vis Sci Tech. 2017;6(1):1.