Omeros has reported the results from the phase 1/phase 2 clinical trial of OMS302, an ophthalmologic PharmacoSurgery product candidate.
OMS302 is a combination of an anti-inflammatory agent and an agent that causes pupil dilation (mydriasis), each with safety and pharmacologic profiles.
The company’s phase 1/phase 2 trial enrolled 61 patients undergoing age-related cataract extraction with lens replacement. The trial was conducted to evaluate efficacy and safety of Omeros’ product candidate, added to a standard surgical irrigation solution.
The study showed that patients treated with OMS302 reported less postoperative pain and demonstrated improvement in maintenance of mydriasis during the surgical procedure, as compared to patients treated with vehicle control.
Reportedly, the trial was a parallel-group, double-blind, vehicle-controlled study evaluating the effects of OMS302 on dilation of the pupil during cataract surgery and on pain, discomfort and inflammation following the procedure.
Gregory Demopulos, chairman and CEO of Omeros, said: We are pleased with the results of this study, which suggest that OMS302 would be useful in helping maintain mydriasis throughout cataract surgery and reducing pain in the early postoperative period. We are moving ahead with additional studies to determine optimal dosing of OMS302’s mydriatic and anti-inflammatory agents.