Omeros (OMER) to Revise Expectations for OMS302; May Expand Indication
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Omeros Corporation (Nasdaq: OMER) reports 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.
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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.
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