Jill Hopkins, MD, discusses results from phase 3a of the Merlin trial for brolucizumab as a treatment for wet AMD and provides updates on KESTREL and KITE trials for the treatment of diabetic macular edema.
Jill Hopkins, MD, Senior Vice President and Global Development Unit Head, Ophthalmology, Novartis Pharmaceuticals, sits down with David Hutton of Ophthalmology Times® to discuss the recent results of the Phase 3a results of the Merlin trial.
Brolucizumab (Beovu, Novartis Pharmaceuticals) is being investigated for the treatment of both wet age-related macular degeneration (AMD) in the MERLIN trial and diabetic macular edema (DME) in the KESTREL and KITE trials.
David Hutton: I'm David Hutton of Ophthalmology Times. We are joined today by Jill Hopkins, Senior Vice President and Global Development Unit Head, Ophthalmology, Novartis Pharmaceuticals, who will provide an update on data the company presented at the American Academy of Ophthalmology is 2021 annual meeting. Thanks for joining us today.
Jill Hopkins, MD: Thanks, David. It's a pleasure to be here. Happy to share with you some of the noteworthy data that we presented at the AAO meeting this past week. We presented on Beovu in both wet AMD and DME, and I'll speak about both of those.
In wet AMD, we presented the results of our Phase 3a Merlin trial, Dr. Khanani presented that. And this was a trial where we looked at the use of Beovu on a monthly basis to treat wet AMD in patients who had persistent disease activity, despite having been treated with prior anti-VEGF. And we were very interested in exploring the capacity, capability, of Beovu to dry the retina and maintain vision in patients in that situation.
And so we looked at monthly Beovu compared to monthly aflibercept. And we found some very interesting results. What we saw, similar to what we'd seen in our pivotal trials with AMD, that we did have noninferiority vision and strong evidence of drying. So we actually were able to show superior drying effects in both the reduction in the central subfield thickness on the OCT measurement, and in the proportion of patients who were fluid free at the end of year one.
We did unfortunately, however, see higher rates of inflammation in the Beovu treated eyes—about 9% in Beovu compared to about 4.5% in aflibercept. And for that reason, we are maintaining our currently labeled dosing recommendation, which is the three loading doses followed then by extension to Q8 or Q12 week dosing and not recommending the monthly in Beovu.
So the other piece of work that we have been presenting and have submitted for approval is our use of Beovu in diabetic macular edema.
So again, we've conducted two pivotal trials, and these were reported at AAO as well, KITE and KESTREL, where we looked at the use of Beovu with a loading phase and then extended intervals. And we're pleased to see in diabetic macular edema as well, this sustained drying, fewer injections and maintenance of visual acuity.
So we're excited by this particularly in a condition like diabetes, where we know that patients are often still working, they're trying to manage multiple health issues related to their diabetes. So anything that we might be able to offer retinal physicians and patients that reduces the burden of injection frequency, while still maintaining very good anatomic control and maintaining vision is exciting to us. And we have submitted those for regulatory approval in the US, in Europe and in Japan. So we're hoping for a positive readout of those submissions in the middle of 2022.