Clinical trials show promise to help mydriasis during cataract surgery

August 19, 2009

Results from the Omeros Corporation for the Phase I/Phase II clinical trial of OMS302, a proprietary combination of an anti-inflammatory agent and an agent that causes pupil dilation (mydriasis) are said to be promising.

Results from the Omeros Corporation for the Phase I/Phase II clinical trial of OMS302, a proprietary combination of an anti-inflammatory agent and an agent that causes pupil dilation (mydriasis) are said to be promising.

Omeros' Phase I/Phase II trial enrolled 61 patients undergoing age-related cataract extraction with lens replacement, and was designed to evaluate efficacy and safety of Omeros' product candidate added to a standard surgical irrigation solution. The data from this study showed that patients treated with OMS302 reported less postoperative pain and demonstrated statistically significant improvement in maintenance of mydriasis during the surgical procedure compared to patients treated with vehicle control. There were no serious adverse events and no discontinuations due to adverse events.

The clinical 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. The trial included three arms of equal size. In the first arm, OMS302 including both the mydriatic and anti-inflammatory agents was added to a standard irrigation solution used in ophthalmologic surgery and delivered directly to the eye during the operation. In the second arm, patients received irrigation solution including only the mydriatic agent, and in the third arm, patients received standard irrigation solution only. For efficacy assessments, patients were monitored for pupil size during surgery and for pain and inflammation for 14 days following surgery.