Omeros Corporation, a clinical-stage biopharmaceutical company, has enrolled its last patient in second phase III clinical trial evaluating OMS302 for use during intraocular lens replacement (ILR) surgery. OMS302, one of Omeros' proprietary PharmacoSurgery products, is added to standard irrigation solution used during ILR procedures to maintain intraoperative mydriasis (pupil dilation) and reduce postoperative pain.
Maintenance of mydriasis is critical to the safety and surgical ease of the procedure, while intraoperative pupil constriction increases the risk of injury to intraocular structures and can substantially prolong surgical time.
In its first phase III clinical trial, OMS302 demonstrated statistically significant superiority over placebo in maintenance of intraoperative mydriasis (p<0.00001) and reduction of postoperative pain (p<0.00001). The second phase III clinical trial, which was the same size (approximately 400 patients) as the first phase III trial, is evaluating the same efficacy and safety measures as the earlier successful phase IIb and phase III clinical trials.
"We have already begun assembling the NDA and MAA for OMS302 and, assuming positive results from the second trial, expect to file these marketing applications with US and European regulators in the first half of 2013," said Gregory A Demopulos, MD, chairman and chief executive officer of Omeros. "We look forward to unlocking and releasing top-line data from our second phase III OMS302 clinical trial later this quarter followed, prior to year end, by phase III data from our OMS103HP programme and phase I data from our PDE10 programme."
OMS302 is Omeros' product being developed for use during intraocular lens replacement (ILR) surgery, including cataract surgery and refractive lens exchange. OMS302 is a proprietary combination of ketorolac, an anti-inflammatory agent, and phenylephrine, a mydriatic (pupil dilating) agent. FDA-approved drugs containing each of these agents have been used in ophthalmological clinical practice for more than 15 years, and both are contained in generic, FDA-approved drugs.
ILR surgery involves replacement of the original lens of the eye with an artificial intraocular lens. These procedures are typically performed to replace a lens opacified by a cataract or to correct a refractive error of the lens (i.e., refractive lens exchange). OMS302 is added to standard irrigation solution used in ILR surgery and delivered intracamerally to maintain intraoperative mydriasis (pupil dilation), to prevent surgically induced miosis (pupil constriction), and to reduce postoperative pain and irritation. Maintenance of mydriasis is critical to the safety and surgical ease of the procedure. Intraoperative pupil constriction increases the risk of injury to intraocular structures and can substantially prolong surgical time.
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