Expert Interview
An international perspective on the potential of intravitreal pegcetacoplan in patients with geographic atrophy after Apellis announces longer-term data from DERBY and OAKS studies
Ticker(s): APLSInstitution: University of Liverpool
- Lead clinician for Age-related macular degeneration(AMD) at Royal Liverpool University Hospital with sub-speciality interests in Medical Retina and Uveitis, Senior Lecturer at the University of Liverpool, member of the NICE Guidelines for AMD 2018 development committee, member of the RCOphth Scientific Committee, and Speciality Co-Lead for Ophthalmology for the regional NIHR Clinical Research Network.
- Actively involved in clinical trials as principal investigator in many multicentre trials in uveitis AMD and diabetic retinopathy, including recently a phase 1 clinical trial in geographic atrophy.
- Research portfolio includes global ophthalmology where he has made seminal discoveries in retinopathy due to cerebral malaria and Ebola and was recently awarded a Wellcome Trust Investigator Award to study OCT as a predictor of outcomes in cerebral malaria in Malawi.
Introductory info - details about your practice, how many dry AMD patients, how many of those with significant geographic atrophy, and how do you currently treat this?
Added By: user1ae2bf5fThe role of complement in progression of geographic atrophy as you see it
Added By: user1ae2bf5fAs an investigator on the OAKS trial, did the 12 month results of the trial meet your expectations? Were you disappointed with the results?
Please give your general impression of the Phase 3 trial data at 12 months from the OAKS and DERBY trials
In particular, in OAKS pegcetacoplan was stat sig with 21% reduction in rate of progression of GA compared to sham, while in Derby it trended positive with 13% reduction vs. sham but not statistically significant. Is this a meaningful benefit?
The numbers at 18 months are just about the same (22% and 13%) with improved statistical separation from placebo for Derby at 18 months. The combined analysis of both trials at 18 months showed 15%/17% vs. sham for EOM/Monthly dosing. Did the 18 month result change your view at all in terms of whether you consider the benefit real?
In the untreated eye analysis, the disease progressed faster in the untreated eye of the monthly dose group in OAKS (7%) and DERBY (11%) compared to sham. Does this call into question in your mind whether the 15-20% benefit observed is actually smaller or perhaps not real?
Added By: user1ae2bf5fIn OAKS, benefit on foveal lesions was 16%, and in Derby the difference was 6% but not even close to stat sig. (Nil for Every other month in derby). So a lot of benefit seems to be driven by extrafoveal lesions. How important is this, and how do you interpret this?
Added By: user1ae2bf5fHow serious is the increased rate of wet AMD found in the treated groups (9.5%) monthly, (6.2%) EOM, vs. (2.9%) Sham ?Will this be a high barrier to its use?
Do you expect regulatory approvals for the monthly dose? Or either dose?
Is the safety profile or the fact that one of the trials failed the biggest barrier to an approval in Europe/UK?
If approved in UK, will NICE recommend this?
How enthusiastic are you about using this in patients assuming it was approved and funded by NICE? Are there particular patients you would target, and do you think it's something patients would want?
Added By: user1ae2bf5fIf you had to rate your level of excitement about pegcetacoplan for GA on a scale of 1-10, what number would you choose and why?
Added By: user1ae2bf5fAre You Interested In These Questions?
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