Presented at ARVO May 11th, 2014 .
Vanessa Caceres
ORLANDO, Fla -- May 11, 2014 -- A dose of a novel RNAi-based compound called bamosiran (SYL040012) significantly reduced intraocular pressure (IOP) in patients with glaucoma, researchers said here at the 2014 Annual Meeting of the Association for Vision and Research in Ophthalmology (ARVO).
Victoria Gonzalez, Sylentis, Madrid, Spain, and colleagues analysed tolerability and the IOP lowering effect of 3 different doses of bamosiran eye drops given every day over 14 days in patients with increased IOP associated with glaucoma.
For the phase 2, double-blind, multicentre study, a total of 89 patients were randomised to receive bamosiran 0.2% 80 mcg/eye/day (0.2%), bamosiran 0.75% 300 mcg/eye/day, bamosiran 2.25% 900 mcg/eye/day, or placebo.
Researchers evaluated local tolerability as assessed by conjunctival and corneal examinations daily; systemic tolerability, and effect on IOP, the latter of which was evaluated with performance of a 24-hour IOP curve prior to the first administration and then on day 14.
Bamosiran 300 mcg/eye/day led to a significant reduction in IOP at day 14 compared with placebo. “This reduction was also statistically significant when compared with the IOP curve performed during the screening period,” said Dr. Gonzalez.
Only 14.6% of patients reported an adverse event and 80% of those were mild in intensity. Headache was the most frequently reported adverse event.
“The only severe adverse event registered throughout the clinical trial was hyponatremia in 1 patient treated with bamosiran 300 mcg, but this event was not considered to be related to the investigational product,” Dr. Gonzalez reported.
The authors concluded that bamosiran was safe and well-tolerated and did not have typical beta blocker side effects such as heart rate reduction.
[Presentation title: Phase 2 of Bamosiran (SYL040012), a Novel RNAi-Based Compound for the Treatment of Increased Intraocular Pressure Associated to Glaucoma]