At AAO, AbbVie presented results from the ARTEMIS study, showcasing IOP lowering that extends beyond the original 20-month timeframe.
At the 2021 American Academy of Ophthalmology (AAO) meeting, Dr Felipe Medeiros of the Duke Eye Centre presented data on Durysta. Dr Michael R. Robinson, Vice President and Global Therapeutic Area Head of AbbVie, sits down to discuss these results.
David Hutton: I'm David Hutton of Ophthalmology Times. I'm joined today by Dr Michael Robinson, who will discuss data on Durysta, presented at the recently concluded American Academy of Ophthalmology 2021 annual meeting. Thank you for joining us today, Dr Robinson.
Dr Michael Robinson: Well, thank you, David. And thank you for the invitation. So I could present some of the Durysta data, talk about this at the 2021 AAO annual meeting. In glaucoma, we did present data on Durysta, which is an intracameral, biodegradable, sustained-release implant that slowly releases bimatoprost.
The first author on this abstract was Felipe Medeiros at the Duke Eye Centre. The implant was FDA approved in March of 2020 for single administration, for lowering the intraocular pressure in patients with open angle glaucoma or ocular hypertension.
The preclinical studies show drug release is complete, and intraocular tissue drug levels are undetectable by about four months after implant administration. However, in clinical trials with Durysta, the duration of IOP lowering had extended beyond the implant drug release. We presented data from an ongoing 24-month extension study of the Phase 3 ARTEMIS studies, assessing the efficacy and duration of the bimatoprost implant.
Patients in the Phase 3 trials received three implants total: one at baseline, one at four months, and then the last one at eight months, then they were followed out to 20 months total follow-up.
What we saw was that there were so many patients that had not been rescued at that 20-month time point that we needed to do an extension study to see how long the implant would actually last. They had received a 10-microgram dose, which is the marketed Durysta, or a 15-microgram dose. And we presented the pooled data in this abstract.
After the 20-month ARTEMIS study, patients then could voluntarily enrol in the extension study to look at the duration of IOP lowering beyond the length of that original study that ended at 20 months. Rescue with topical IOP lowering drops was allowed if in the opinion of the investigator of the study eye did not meet or maintain IOP expectations.
The outcome measures included the number of patients who had received no additional rescue IOP lowering treatment in the study eye for greater than two years and three years after the third implant administration in the ARTEMIS trials.
We also looked at the IOP and visual field mean deviation in the study eye of these patients. Results show that approximately 200 patients had volunteered to be enrolled in the extension study after completing an ARTEMIS trial. 69 had not been rescued yet at screening, 54 patients remained untreated for greater than two years after the third implant administration in the ARTEMIS trial, and 18 patients remained untreated for greater than three years after the third implant administration in the ARTEMIS trial.
The main baseline IOP is of these patients in these super responders were in the 23 to 24 range at the start of the ARTEMIS trials, and at the last mean IOP documented in the extension studies, the IOP was in the 16 to 17 range—off drops. The mean deviation of visual field testing of the super responder patients were stable over the past two to three years following their last implant.
So in conclusion, after their last bimatoprost implant treatment in the Phase 3 trials, patients can have a sustained IOP lowering for greater than two years, some greater than three years, without any additional treatment, and they maintained stable visual fields. The prolonged effect on IOP lowering could result from the bimatoprost stimulated upregulation of matrix metalloproteinases, leading to sustained tissue remodelling of outflow pathways. Clinical studies are in progress to further understand the duration of IOP lowering of Durysta and factors that may predict this long-term response.