The following transcript has been edited for clarity.
Diana V. Do, MD: Hi, I’m Diana V. Do, MD. Welcome to Retinal Physician. Today I’m joined by a leader in retina, Jennifer Kang-Mieler, PhD, who presented very exciting data on STAR-DDS, a new way to provide sustained delivery of aflibercept. Tell us about this new innovation.
Jennifer Kang-Mieler, PhD: So this is a fully biodegradable microsphere hydrogel system that is designed to deliver aflibercept for 6 months or longer. It is a composite system that we can actually inject directly into the vitreous, and it lasts for 6 or 7 months.
Dr. Do: And how does it do it? I mean, now we inject second-generation [anti-VEGFs] that have higher molar doses. Is this also in combination with a higher molar dose? How does it work to provide this durability?
Dr. Kang-Mieler: The idea is that the drug is encapsulated into the microspheres, which are slowly releasing it. And we all know that we don’t need a lot of drug to have effect. And so by the sustained delivery, you can actually have effects much longer and that’s how we can actually create a longer, more durable therapy.
Dr. Do: Are you foreseeing any safety risks with this? Is it compatible with intraocular pH? Tissues?
Dr. Kang-Mieler: So we recently just finished the long-term safety study in nonhuman primates. And what’s really exciting about it is that we have not seen any complications. There were no changes in intraocular pressure (IOP). There were no changes in electroretinogram (ERG) recordings or on optical coherence tomography (OCT), including retinal thickness measurements. So that’s really exciting. And we've actually done both single injection and repeat injections and followed the animals for over 2 years and really see no changes at all. So that’s very exciting news.
Dr. Do: What are the next plans?
Dr. Kang-Mieler: Next plans, I’d really love to get into clinical trial. We really are trying to get into that place where we can actually test these in patients and make sure that it’s safe and actually can deliver aflibercept for much longer. Really, the end goal is to reduce this treatment burden. We all know that this is something that’s been going on for too many years and if we can treat our patients better and longer, I think this is our main goal.
Dr. Do: Well, congratulations on all of this amazing work. We look forward to future human data and congratulations again. RP







