Introduction
Oral administration of
zeaxanthin (Zx) 20 mg daily in patients with unilateral neovascular age-related macular degeneration (nAMD) treated with triple therapy (photodynamic therapy/intravitreal bevacizumab/intravitreal dexamethasone) reduced fellow-eye 2-year nAMD incidence from 23 to 6% (
p
= 0.02) in a prior clinical trial. We questioned the long-term benefit and thus analyzed case–control 5-year patient data of trial participants and additional participants with 5-year follow-up, also performing cost-utility and cost–benefit analyses.
Methods
Consecutive, unilateral nAMD patient outcomes for those taking 20 mg Zx supplementation orally for ≥ 5 years were compared with the Comparison of AMD Treatments Trials (CATT) 5-year historical controls for fellow-eye nAMD conversion. Eleven-year mean life expectancy, cost-utility and cost–benefit models were undertaken employing a 3% discount rate and 2020 US real dollars.
Results
Among 227 consecutive patients with nAMD/Zx-supplementation, 202 (90%) had 5-year follow-up. The fellow-eye nAMD 5-year conversion incidence using a Kaplan–Meier cumulative event estimate was 22% (49/227), versus 48% (167/348) with CATT control data (
p
< 0.0001). An 11-year cost-utility model with estimates for years 6–11 demonstrated a 0.42 (7.7%) QALY (quality-adjusted life-year) gain, including 3 months of life saved per patient due to decreased nAMD fellow-eye conversion. This yielded a direct ophthalmic medical cost perspective, incremental cost-utility ratio (CUR) of −$576/QALY and a societal cost perspective CUR of −$125,071/QALY. Zx supplementation for all 2020 US unilateral nAMD cases would have theoretically saved society, primarily patients, $6.0 billion over 11 years, a 1531% return on investment (ROI), or 31.3% annual ROI, on Zx costs.
Conclusions
Oral zeaxanthin supplementation for unilateral nAMD patients appears to decrease fellow-eye long-term incidence and is cost-effective and financially rewarding. It is dominant vs. no supplementation in patients presenting with unilateral nAMD.
Trial Registration
ClinicalTrials.gov identifier, NCT01527435.
Supplementary Information
The online version contains supplementary material available at 10.1007/s40123-023-00742-9.