SEATTLE, Feb. 7, 2012 /PRNewswire/ -- Omeros Corporation (NASDAQ: OMER - News) today announced that recent positive clinical developments have allowed it to revise the planned analysis for its ongoing Phase 3 clinical trial evaluating OMS302, which Omeros believes expands opportunities for the product's clinical and regulatory success. OMS302 is a proprietary combination of an anti-inflammatory active pharmaceutical ingredient (API) and an API that causes mydriasis (pupil dilation), each with well-known safety and pharmacologic profiles. The product candidate is added to standard irrigation solution used during cataract surgery and other lens replacement procedures to maintain intraoperative mydriasis and to reduce postoperative pain.
Last year, Omeros reported a successful 221-subject Phase 2b clinical trial that evaluated OMS302 in patients undergoing cataract surgery. OMS302 was compared to the mydriatic API alone, the anti-inflammatory API alone and vehicle, each arm consisting of approximately 55 patients. In this trial, each API in OMS302 contributed to the efficacy of the product. Patients in the OMS302 group demonstrated statistically significant maintenance of mydriasis over both the group that received only the anti-inflammatory API (p<0.0001) and the vehicle-treated (p<0.0001) group. Similarly, the OMS302-treated group demonstrated a statistically significant reduction in pain compared with both the group that received only the mydriatic API (p=0.0089) and the vehicle-treated (p=0.0418) group.
In connection with the Company's continuing analysis of data from its Phase 2b clinical trial, Omeros determined that OMS302 was statistically significantly superior in preventing clinically meaningful miosis (pupil constriction) when compared to each of the other three treatment arms (p=0.0005 vs. the anti-inflammatory, p=0.0404 vs. the mydriatic and p<0.0001 vs. vehicle). Clinically meaningful reduction in pupil diameter is associated with an increase in procedure-related complications, including posterior capsule tears, retained lens fragments and vitreous leaks. The mydriatic API and the anti-inflammatory API in OMS302 are known to cause mydriasis and prevent miosis, respectively. The analysis of pupil diameter in the Phase 2b trial demonstrates that each API in OMS302 contributed to the maintenance of mydriasis seen in the Phase 2b trial. Given these data, Omeros is revising the planned analysis for the current Phase 3 trial to identify maintenance of mydriasis as the single primary endpoint rather than as a co-primary endpoint with pain reduction. Pain reduction will be assessed as a secondary endpoint. Omeros believes that this approach increases the number of paths for clinical-outcome and regulatory-approval success for OMS302.
"Our confirmation that the anti-inflammatory agent in OMS302 inhibited miosis in the Phase 2b clinical trial provides us with multiple opportunities for success in this program," said Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros. "By selecting mydriasis as the single primary endpoint, we maintain our ability to access these opportunities. We look forward to reading out data from the first OMS302 Phase 3 clinical trial later this quarter."
As previously reported, Omeros will initiate its second Phase 3 clinical trial for OMS302 following a meeting with European regulators to ensure that the current trial design satisfies Omeros' marketing objectives in Europe. That meeting is scheduled for later this quarter. In the interim, the pace of enrollment in the ongoing Phase 3 trial has exceeded expectations. Total enrollment will exceed 400 patients. The additional patients will count toward the FDA's requested total drug-exposure population and are expected to reduce overall OMS302 development costs without delaying the program. Increasing the patient population raises the calculated statistical power level for the primary mydriasis endpoint and secondary pain endpoint to over 99 percent and 95 percent, respectively. Database lock and data release from this clinical trial remain on schedule for later this quarter.
Omeros' OMS302 Program OMS302 is Omeros' PharmacoSurgery™ product candidate being developed for use during ophthalmological procedures including cataract and other lens replacement surgery. OMS302 is a proprietary combination of an anti-inflammatory active pharmaceutical ingredient (API) and an API that causes mydriasis (pupil dilation), each with well-known safety and pharmacologic profiles. FDA-approved drugs containing each of these APIs have been used in ophthalmological clinical practice for more than 15 years, and both APIs are contained in generic, FDA-approved drugs.
In a 221-subject Phase 2b clinical trial that evaluated OMS302 in patients undergoing cataract surgery, OMS302 demonstrated clinically meaningful and statistically significant benefits in both prespecified co-primary endpoints – maintenance of intraoperative mydriasis and reduction of pain in the early postoperative period. Also, the anti-inflammatory API contributed to maintenance of mydriasis. In addition, fewer OMS302-treated subjects reported moderate and severe postoperative pain. In this study, OMS302 was safe and well tolerated without evidence of drug-related adverse events.