Santen Files for Marketing Approval in Japan for Atropine Drops to Delay Myopia

Santen Pharmaceutical announced Feb. 28 that it had filed for marketing approval in Japan of DE-127 (0.025% atropine sulfate hydrate eye drop), designed to slow the progression of myopia.

The product would be the first approved in Japan for that indication, Santen said.

DE-127 was jointly developed by Santen and the Singapore Eye Research Institute.

Atropine inhibits muscarine receptor activity, aiming to prevent the thinning or stretching of the sclera and slow the elongation of the axial length of the eye.

Myopia occurs when the eye grows longer, resulting in the focusing of light rays in front of the retina. High myopia can place a patient at increased risk of sight-threatening conditions such as glaucoma, retinal tears and detachment, and myopic macular degeneration.

Progressive myopia is a serious concern, particularly in Asia. Santen said Japanese health officials had determined that myopia affects 37.9 percent of the nation’s elementary school children, with the number increasing to 61.2 percent in junior high school and 71.6 percent in high school.

In clinical trials, DE-127 was found to slow the change in spherical equivalent refraction and suppress the elongation of the axial length of the eye. Benefits were shown to be sustained over a three-year period.