|Omeros Corporation Continues To Look Strong|
|By Brian Wilson|
|Thursday, 29 March 2012 05:25|
PharmacoSurgery™ is a preemptive drug system developed specifically for patients undergoing surgery. It aims to treat post-operative symptoms like inflammation and pain before they occur in post-operative care using FDA-approved products.
The first of Omeros’ two primary drugs is currently called OMS103HP, which has been developed as an irrigation additive to patients while they are undergoing arthroscopic surgery. This type of surgery is minimally invasive and is generally used for operations on patients’ joints. There are currently no commercially available drugs that preemptively improve a patient’s post-operative recovery after arthroscopic surgery, so the penetration rate of this drug upon an FDA approval could hypothetically be very high.
In addition to this, results from a completed Phase II trial released in 2010 demonstrated that the drug had indeed provided statistically significant clinical benefit in patients who were treated with OMS103HP, which meant they had meaningful improvements in things like pain recovery and range of motion relative to the control group. Phase III trials are being coordinated now.
The other lead drug candidate for Omeros is OMS302, which is the PharmacoSurgery™ drug being developed for ophthalmologic surgery. This drug is a proprietary combination of generic agents that work as anti-inflammatory agents and pupil-dilators. The idea is that surgery on the eye is more efficient in terms of operating time and recovery time if the eye is in a constant state of mydriasis (fully dilated pupils) since it’s easier to avoid unnecessary damage to the surrounding tissue. The anti-inflammatory agent likely targets the MASP-2 protein which, as stated, can theoretically work as a powerful anti-inflammatory agent without any effects on the body’s natural ability to fight infection.
OMS302 has released very positive results from its Phase III clinical trials. Primary endpoints were met regarding the maintenance of mydriasis (pupil dilation) as well as in pain reduction in the postoperative period. 405 patients were enrolled, and there were no signs that OMS302 caused more adverse effects relative to patients undergoing ophthalmologic surgery without the drug.
The BioMedReports FDA Calendar shows that the company has three important upcoming catalysts in 2012 including some additional trial results and a recently announced plan to begin enrolling patients in OMS302 second Phase III trial early April 2012. Their plan is to submit marketing applications in both the U.S. and Europe in the first part of 2013.
OMER was recently upgraded to a BUY from HOLD by Canaccord Genuity. If you are interested in hearing more, please note that Gregory A. Demopulos, M.D., chairman and chief executive officer, is scheduled to present at the following two conferences:
11th Annual Needham Healthcare Conference
Future Leaders in the Biotech Industry Conference