Science

In the last two years the World Health Organization (WHO), American Academy of Ophthalmology (AAO) and the World Society of Paediatric Ophthalmology and Strabismus (WSPOS) have issued public statements identifying myopia as a massive global health problem and that myopia represents a major unmet medical need with no approved drugs to treat the disease. Myopia tends to increase the most in children between the ages 8 and 15. While the precise mechanism responsible for causing myopia is unknown, the disease is believed to involve both genetic and environmental components.

Commercially available atropine (1.0% and 0.5%) has been tested and been shown to be effective in treating the progression of myopia, however these high doses also have a very high incidence of adverse events that typically result in discontinuation of treatment. As a result, progressively lower doses of atropine have been tested to optimize the safety versus efficacy. It has been found that 0.01% atropine given once a day retains virtually the same efficacy as 1% atropine, but with almost no side effects. This was recognized in 2017 with consensus statements by the AAO and the WSPOS acknowledging low-dose atropine as the preferred treatment paradigm with a favorable risk-benefit ratio to minimize myopic progression. As no formulations of 0.01% atropine are approved anywhere in the world, physicians have to write off label prescriptions for compounding pharmacies to supply their patients.

Unfortunately, compounded (0.01%) atropine is pharmacologically unstable, resulting in 5% degradants after 3 months at room temperature resulting in a product with short term (~30 day) shelf life. The nearer to physiologic pH (~7.4) and the lower the atropine concentration, the higher the rate of degradation. Unstable drug product poses numerous concerns for all stakeholders involved including regulatory agencies, health care professionals, and most importantly patients.

Sydnexis has uniquely solved this problem with a novel, stable, topical eyedrop formulation designed to be administered once daily at bedtime.

For WSPOS Consensus Statement on Myopia and a brief discussion of the use of atropine to slow the progression of myopia please click here.

For more information on myopia, please visit the AAO website here. For more information on myopia treatments, click here.

Science

In the last two years the World Health Organization (WHO), American Academy of Ophthalmology (AAO) and the World Society of Paediatric Ophthalmology and Strabismus (WSPOS) have issued public statements identifying myopia as a massive global health problem and that myopia represents a major unmet medical need with no approved drugs to treat the disease. Myopia tends to increase the most in children between the ages 8 and 15. While the precise mechanism responsible for causing myopia is unknown, the disease is believed to involve both genetic and environmental components.

Commercially available atropine (1.0% and 0.5%) has been tested and been shown to be effective in treating the progression of myopia, however these high doses also have a very high incidence of adverse events that typically result in discontinuation of treatment. As a result, progressively lower doses of atropine have been tested to optimize the safety versus efficacy. It has been found that 0.01% atropine given once a day retains virtually the same efficacy as 1% atropine, but with almost no side effects. This was recognized in 2017 with consensus statements by the AAO and the WSPOS acknowledging low-dose atropine as the preferred treatment paradigm with a favorable risk-benefit ratio to minimize myopic progression. As no formulations of 0.01% atropine are approved anywhere in the world, physicians have to write off label prescriptions for compounding pharmacies to supply their patients.

Unfortunately, compounded (0.01%) atropine is pharmacologically unstable, resulting in 5% degradants after 3 months at room temperature resulting in a product with short term (~30 day) shelf life. The nearer to physiologic pH (~7.4) and the lower the atropine concentration, the higher the rate of degradation. Unstable drug product poses numerous concerns for all stakeholders involved including regulatory agencies, health care professionals, and most importantly patients.

Sydnexis has uniquely solved this problem with a novel, stable, topical eyedrop formulation designed to be administered once daily at bedtime.

For WSPOS Consensus Statement on Myopia and a brief discussion of the use of atropine to slow the progression of myopia please click here.

For more information on myopia, please visit the AAO website here. For more information on myopia treatments, click here.