At-home subcutaneous anti-VEGF injection for wet AMD, DME is safe, effective in Phase 1 trial

Jeff Cleland, PhD, CEO of Ashvattha, discusses safety data for an at-home subcutaneous injection option being developed for wet age-related macular degeneration (AMD) and diabetic macular edema (DME). The anti-VEGF candidate will enter a Phase 2 study later this year.

Video transcript

David Hutton (DH): Hello, I'm David Hutton of Ophthalmology Times. ® I'm joined today by Dr. Jeff Cleland, CEO of Ashvattha, who will discuss safety data for an at home subcutaneous injection option being developed for wet MD, and DME. The anti VEGF candidate will enter a Phase 2 study later this year. Thanks for joining us, tell us about this project.

Jeff Cleland, PhD (JC): Thank you, David, I really appreciate the opportunity to join you today. The thesis behind this project came about by the fact that right now everyone has to get an injection with a needle in the eye that gets treated for many of these retinal diseases. And often that occurs every 6 to 8 weeks. And so it's really a heavy treatment burden, not just on the patients. Many of the physicians that we've talked to, are really facing a challenge today, being able to actually treat enough patients because of the heavy treatment burden of having to do this administration. 

We’ve looked at it, even from the early days and when I worked at Genentech, is there a way we can deliver the drug systemically, and really have the same effect as an ejection in the eye without the safety side effects? And so that's been our goal and our challenge with our product.

What we are able to show at this year's ARVO is that we are able to dose very safely a very potent anti-angiogenic agent to patients using a subcutaneous administration. And this allows us then to have at-home use of the product by the patients so they can self-administer. Eventually, we will get to market with an auto injector similar to what they do already with an insulin device or something like that. And so it makes it much easier on the patient, also easier on the physician. They still have to routinely go back and obviously be checked by the retina ophthalmologist, but at the same time, they wouldn't have to come back in for regular injections into the eye. We think this is going to be a real alleviation of the treatment burden for patients and providers. Many patients over time do get burned out and stop coming back for treatment. So maybe we can save a few patients vision over the long term as well.

DH: Ultimately, what can this mean for patients?

JC: I think the great advantage of this is that the patients that maybe don't even want to consider a needle in the eye will now have an option that's better, and provides them a chance to continue to maintain their vision and make it easy for them to self-administer at home. Eventually, and we're working on this now in the background as well, a possible oral dosage form of the same product. We can offer patients a pill at some point in the future, instead of having an injection in the eye.

DH: You alluded to it, but what's the next step for this study?

JC: So the next step is that we're about to start enrolling patients and a Phase 2 program. These are wet age related macular degeneration patients and diabetic macular edema patients. They've already been treated with an anti-VEGF previously, and they've shown a response to that, but they have to keep coming back in for those intravitreal injections. And so instead of having their next intravitreal injection, they would come back in and get an injection of Eylea or aflibercept. We'd see how long they respond to that injection. So we have a control baseline. And once they have a return of subretinal fluid back to baseline, they'll get a subcutaneous dose of our drug, and we'll again follow them and see how long they respond and how well they respond to our drugs. Each patient becomes their own control in the first part of the study. We think this will be a very powerful study to show that the drug actually does have the potential for therapeutic benefit in these patients.

DH: Thank you so much for taking a little time to catch up again with us and I appreciate it.

JC: Thank you. I appreciate the opportunity.

Note: This transcript has been lightly edited for clarity.