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HomeminewsTGA Approves First Myopia Atropine Drops

TGA Approves First Myopia Atropine Drops

Eikance 0.01% eye drops (Aspen Australia) have been registered on the Australian Register of Therapeutic Goods (ARTG) as a treatment to slow the progression of myopia in children aged from four to 14 years. Treatment may be initiated in children when myopia progresses by one or more dioptres per year.1,2 Eikance 0.01% eye drops are the first atropine prescription product to be registered on the ARTG indicated for slowing the progression of this increasingly common condition in children, which increases the risk of sight-threatening eye diseases in adulthood, including retinal detachment, glaucoma, cataracts and myopic macular degeneration.1,2,3,4 The prescription therapy is available from community pharmacies in sterile, preservative-free, single dose unit packs.

“The registration of Eikance 0.01% eye drops provides ophthalmic prescribers with an important treatment option in helping to slow myopia progression in children with this increasingly common cause of vision impairment,” said Professor John Grigg, consultant ophthalmologist.

This facilitates the clinician to have options to prescribe low dose atropine to slow myopia progression, which has been highlighted in the ATOM 2 and Low-Concentration Atropine for Myopia Progression (LAMP) studies. These options assist in ensuring all young patients have the best possible chance of managing myopia progression and minimising its long-term effects on eye health,” said Professor Grigg.

POSITIVE STUDIES

The regulatory approval of Eikance 0.01% eye drops involved several studies, with ATOM 2 and LAMP being the key clinical studies.2 In ATOM 2, a randomised, double-blind, threearm, active control, parallel group study, the rate of myopia progression was compared in 400 children with myopia (mean refractive error -4.5 to -4.8D) aged six to 12 years treated with 0.5%, 0.1% or 0.01% atropine eye drops* for two years (phase 1).2 Treatment was then stopped for 12 months (phase 2) and children who had myopia progression (≥–0.50D in ≥1 eye) during phase 2 were restarted on atropine 0.01% for a further 24 months (phase 3).5 The placebo arm from the ATOM 1 study was used as a historical control.2 The study demonstrated a 60% slowing of myopia progression with atropine 0.01% eye drops after two years when compared to placebo.2,5,6 After five years, the overall progression of myopia in the 0.01% atropine group was -1.38 Å} 0.98D.5

In LAMP, a randomised, double-blind, fourarm, placebo-controlled, parallel group study, the rate of myopia progression was compared in 438 children with myopia (mean refractive error -3.71 to -3.98D) aged four to 12 years treated with 0.05%, 0.025% or 0.01% atropine eye drops* or placebo drops over 12 months of treatment (Phase 1).2 In the extension phase (phase 2), children in the initial placebo group were switched to receive 0.05% atropine from the beginning of the second-year follow-up, whereas those in the 0.05%, 0.025%, and 0.01% atropine* groups continued with the same regimen.2 Changes in spherical equivalent (SE) and axial length (AL) and their differences between groups was the main outcome measure.2,7,8 The study showed that SE progression (myopia progression) was significantly slower after 12 months of treatment with atropine 0.01% vs placebo (-0.59 Å} 0.61D vs –0.81 Å} 0.53D; p=0.006).2,7 The mean change in AL at 12 months was similar between atropine 0.01% vs placebo (0.36 Å} 0.29 mm vs 0.41 Å} 0.22 mm; p=0.18, not statistically significant).2,7 Compared with the first year of treatment, the use of atropine 0.01% in the second year demonstrated further improvement in SE progression (– 0.64 Å} 0.56D in first year vs –0.48 Å} 0.44 D in second year; p=0.04).8 This was also the case for the mean increase in the axial length (0.35 Å} 0.24mm in the first year vs. 0.25 Å} 0.18mm in the second year; p=0.001).

WELL TOLERATED

Eikance 0.01% eye drops are generally well tolerated.2 In clinical trials evaluating the safety of 0.01% atropine eye drops when administered to myopic children treated for up to two years, the most common (≥1% and <10%) reported adverse events were photophobia, blurred vision, poor visual acuity and allergy.2 Aspen Asia Pacific CEO, Mr Trevor Ziman, welcomed the TGA registration saying, “Childhood myopia is a growing public health concern, and we are delighted to now bring 0.01% atropine eye drops to market that has the backing of 32 published articles evaluating the safety and efficacy of atropine eye drops to manage myopia progression in children and adolescents. We are committed to helping stem the tide of myopia progression in Australian children.”

 References 

  1. Therapeutic Goods Administration (TGA). 2021. Summary for ARTG Entry: 331960 [online] Available at https://www.ebs.tga. gov.au [Accessed 2 February 2022] 
  2. Australian Approved EIKANCE 0.01% eye drops (atropine sulfate monohydrate 0.01%). Product Information. Last Updated 25 Nov 2021. 
  3. Holden, B., Fricke, T., Wilson, D., Jong, M., Naidoo, K., Sankaridurg, P., Wong, T., Naduvilath, T. and Resnikoff, S., 2016. Global Prevalence of Myopia and High Myopia and Temporal Trends from 2000 through 2050. Ophthalmology, 123(5), pp.1036-104
  4. Wang, W., Chen, C., Chang, J., Chien, L., Shih, Y., Lin, L., Pang, C., Wang, I. Pharmacotherapeutic candidates for myopia: A review. Biomedicine & Pharmacotherapy, 133 (2021) 111092, pp.1-17. 
  5. Chia, A., Lu, Q. and Tan, D., 2016. Five-Year Clinical Trial on Atropine for the Treatment of Myopia 2. Ophthalmology, 123(2), pp.391-399. 
  6. Chua, W., Balakrishnan, V., Chan, Y., Tong, L., Ling, Y., Quah. B., Tan, D. 2006. Atropine for the Treatment of Childhood Myopia. Ophthalmology, 113(12), pp.2285-2291. 
  7. Yam, J., Jiang, Y., Tang, S., Law, A., Chan, J., Wong, E., Ko, S., Young, A., Tham, C., Chen, L. and Pang, C., 2019. Low- Concentration Atropine for Myopia Progression (LAMP) Study. Ophthalmology, 126(1), pp.113-124. 
  8. Yam, J., Li, F., Zhang, X., Tang, S., Yip, B., Kam, K., Ko, S., Young, A., Tham, C., Chen, L. and Pang, C., 2020. Two-Year Clinical Trial of the Low-Concentration Atropine for Myopia Progression (LAMP) Study. Ophthalmology, 127(7), pp.910-919.

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