Pirenzepine gel slowed myopia progression in children over 2 years

Administering 2% pirenzepine ophthalmic gel to children with moderate myopia delayed the rate of progression over 2 years, a multicenter, randomized study found.

R. Michael Siatkowski, MD, and colleagues in the U.S. Pirenzepine Study Group evaluated the safety and visual benefit of pirenzepine ophthalmic gel in 117 healthy children between 8 and 12 years of age with a spherical equivalent between –0.75 D and –4 D and astigmatism of 1 D or less at baseline. These subjects were compared with 57 age-matched controls who received placebo. The study group received 2% pirenzepine ophthalmic gel twice daily in each eye for 2 years.

At baseline, spherical equivalent averaged –2.10 D in the pirenzepine group and –1.93 D in the placebo group.

At 1 year, the pirenzepine group experienced an average increase in myopia of 0.26 D, significantly less compared with an average increase of 0.53 D in the placebo group (P < .001). After 1 year, 53 patients in the pirenzepine group and 31 patients in the placebo group decided to participate in the study for a second year.

At 2 years, the pirenzepine group experienced an average increase in myopia of 0.58 D, significantly less compared with an average increase of 0.99 D in the placebo group (P = .008).

During the first year, 13 patients in the pirenzepine group dropped out of the study due to adverse events; one additional patient dropped out during the second year, according to the study, published in the August issue of Journal of AAPOS.