www.omeros.com
Omeros Corporation is a clinical-stage biopharmaceutical company. It is engaged in discovering, developing and commercializing products focused on inflammation and disorders of the central nervous system.
Omeros revises study endpoints following evaluation of successful phase 2 results
Omeros (NASDAQ:OMER) said Tuesday it has revised the endpoints for its ongoing phase three clinical trial of its OMS302 drug, such that the maintenance of mydriasis will alone be the primary endpoint, rather than a co-primary endpoint with pain reduction.
Pain reduction will be assessed as a secondary endpoint, the company said.
The OMS302 drug consists of a combination of an anti-inflammatory active pharmaceutical ingredient (API) and an API that causes pupil dilation, or mydriasis. Each API involved has well-known safety and pharmacologic properties, Omeros said.
Last year, the company completed a successful phase 2b trial, evaluating 221 patients undergoing cataract surgery.
During the trial, either the OMS302 drug, a mydriatic API, an anti-inflammatory API, or a non-API vehicle, were added to the standard irrigation solution during the surgery, in order to maintain mydriasis and reduce post-operative pain.
Omeros found that its OMS302 drug demonstrated statistically significant maintenance of mydriasis over both the anti-inflammatory API group and the vehicle-treat group, and also demonstrated a statistically significant reduction in pain compared to the mydriatic API and the vehicle-treat group.
The drug was also found to prevent "clinically meaningful pupil constriction", or miosis, when compared to each of the other three treatment arms.
"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 CEO, Dr. Gregory A. Demopulos.
"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."
Enrollment for the ongoing phase three trial has exceeded expectations, the company said, with total enrollment anticipated at over 400 patients. The results from this trial will be released later this quarter, the company added.
The company also said it will initiate its second phase three trial for the OMS302 drug following a meeting with European regulators, which is scheduled for later this quarter.
On the Nasdaq Exchange, Omeros shares rose 6.06 percent to $6.30, as of 12:59 pm EDT.
