Abstract
Purpose :
The CHAMP phase 3 trial demonstrated that NVK002 atropine 0.01% significantly increased the proportion of myopic children who progressed less than 0.50 D in spherical equivalent refraction (SER) over 36 months of nightly dosing (responders). Stage 2 of CHAMP assessed the impact of continued dosing of NVK002 on myopia control and the occurrence of myopia rebound upon cessation of NVK002 dosing over an additional 12 months.
Methods :
116 of the 164 participants aged 3 to 16 years (intent-to-treat set) at baseline in the EU and US with SER between −0.50 D to −6.00 D who were randomized to receive nightly NVK002 0.01% eye drop for 36 months in Stage 1 continued to Stage 2. Among those participants, 38 were re-randomized to continue treatment with NVK002 0.01% for 12 months, for a total of 48 months dosing, while 39 were re-randomized to placebo for 12 months to assess rebound of myopia. Cycloplegic SER and axial length (AL) were measured at 48 months.
Results :
Among the 38 participants who continued 12 additional months of dosing with NVK002 0.01%, mean SER changed -0.95 D (SD 0.82 D) from study baseline, and mean AL changed 0.61 mm (SD 0.62 mm) from study baseline. Among the 39 participants re-randomized from NVK002 0.01% to 12 months of placebo, mean SER changed -1.12 D (SD 0.78 D), and mean AL changed 0.78 mm (SD 0.42 mm). The between-group least square mean difference (0.01% to 0.01% – 0.01% to placebo) in SER change from study baseline at Month 48 was 0.17 D (95% CI [-0.23, 0.57], p=0.4). There were no serious ocular treatment-emergent adverse events (TEAE). The most common ocular TEAE was dry eye (NVK002 0.01%: 7.5%; Placebo: 2%;).
Conclusions :
These findings from Stage 2 of the CHAMP phase 3 trial suggest that NVK002 low-dose atropine 0.01% continues to be both effective and safe in treating pediatric myopia progression following four years of nightly dosing. Moreover, after switching to placebo drops for one year following three years of dosing with NVK002 0.01%, there was no meaningful rebound effect. These data support NVK002 0.01% as a potential long-term treatment for pediatric myopia.
This abstract was presented at the 2024 ARVO Annual Meeting, held in Seattle, WA, May 5-9, 2024.