What is Myopia Progression?
Myopia, also known as nearsightedness, usually continues to worsen year after year before the age of 17. It is caused by an increase in eye ball length or corneal curvature and this condition causes light from distant objects to focus in front of the retina, which leads to blurred long-distance vision, generally characterized by a refractive error of −0.5 or −1 diopters. It has been estimated that currently 1.4 billion people in the world are myopic (22.9% of the population), and crude estimates suggest that, by 2050, there will be 4.7 billion people affected (nearly 50% of world population). If left uncorrected, myopia has been shown to have major consequences on children’s level of education, quality of life, and personal and psychological well-being, and its economic impact on society has been estimated at US$244 billion from global potential productivity loss.
Current therapeutic options all have limitations; for example, orthokeratology (reshaping of the cornea by a hard, hydrophilic, gas-permeable contact lens worn during sleep and removed during the day) does not stop disease progression to returning to its previous rate after treatment discontinuation and requires high levels of patient compliance. The use of correction glasses or lenses does not address the root-cause, refractive surgery is only curative, and its cost-effectiveness is still uncertain. Pharmacological treatments have shown some promising potential. Of these, mydriatic agents such as atropine gained interest.
Several clinical trials have evaluated the safety and efficiency of atropine eye drops. The ATOM2 trial studied myopia progression in 400 children 2 years after treatment with 0.01%, 0.1%, and 0.5% atropine sulfate ophthalmic solutions and found the 0.01% concentration to be the concentration causing the least side effects for comparable efficacy in controlling myopia progression. The LAMP phase 2 trial report confirmed that concentrations ranging from 0.01% to 0.05% atropine sulfate ophthalmic solutions were well tolerated in 383 children after two years of treatment, with patients experiencing rare and mild side effects.
Atropine sulfate ophthalmic solution has been used in some countries to treat myopia patients, the instability of atropine in the aqueous formulation has limited product shelf life, which has impacted the widespread usage of the product for the treatment. Cloudbreak has developed a novel ophthalmic formulation which will substantially improve atropine stability in the formulation and ultimately product shelf life in preventing myopia progression.