A stroke of the eye: Sudden vision loss with no current treatment
NAION (Nonarteritic Anterior Ischemic Optic Neuropathy), is a stroke of the optic nerve that causes sudden visual impairment to the point of blindness. It is a leading cause of sudden optic nerve-related vision loss, predominantly in the Caucasian population over 50 years of age. The cause of NAION is unclear, but it is associated with diabetes, systemic hypertension, and ischemic heart disease. More than 200,000 people a year suffer from NAION. Prognosis for these patients is poor, with up to 50% having acuity of 20/200 (6/60) or less, with significant visual field loss and permanent visual impairment. There are no approved treatments for NAION. Until now.
With RPh201, patients showed improvement in a Phase 2 study
We have recently completed a Preliminary Double-Masked Clinical Study Evaluating the Safety and Efficacy of RPh201 in Subjects With Previous NAION. Twenty patients with established NAION—ranging from six months to three years—participated in the study.
A Phase 2a, prospective, single-center, double-masked, placebo-controlled, randomized trial in 20 patients with previous NAION (diagnosed ≥ 6 months previously) was conducted. Participants were dosed twice weekly by subcutaneous injection with either 20 mg RPh201 (n = 12) or placebo (n = 8) for up to 26 weeks. The primary efficacy analysis was change in best-corrected visual acuity (BCVA), measured with ETDRS charts.
- 36.4% of treated subjects improved more than 15 letters compared to 12.5% in the placebo group after 26 weeks.
- There was a trend of improvement of VF sensitivity in subjects treated with RPh201, which was more pronounced in on-chart patients.
- The average improvement in RPh201-treated subjects was twice that of the placebo group (15 vs 7 letters)
- RPh201 treatment could potentially improve visual function in patients with previous NAION.