) recently reported mixed results from its first pivotal phase
III study that was being conducted with OMS103HP in patients
undergoing arthroscopic partial meniscectomy surgery.
The candidate failed to meet its primary endpoint (Symptoms
Subscale of the Knee Injury and Osteoarthritis Outcome Score
[KOOS]) in the study. However, Omeros said that OMS103HP achieved
statistical significance in the secondary endpoint - pain
measured in the early postoperative period.
An improvement was observed in other pain-related assessments
like postoperative narcotic usage, the occurrence of inflammatory
adverse events, use of tourniquets and crutches and time to
discontinuation of crutches and return to work.
Despite not meeting the primary endpoint, Omeros intends to go
ahead with the second phase III trial which is scheduled to
commence in the first half of 2013.
Arthroscopy is a large market - according to the company, more
than 8 million arthroscopic procedures were carried out across
the world in 2012 with the US accounting for more than half these
procedures. The successful development of OMS103HP would open up
significant commercial opportunity for the company.
Meanwhile, we note that Omeros has another late-stage
candidate in its pipeline. The company is looking to submit a new
drug application for its ophthalmic surgery candidate OMS302
early this year. The candidate could be launched as early as
Another promising candidate is OMS824, the lead compound in
Omeros' phosphodiesterase 10 (PDE10) program. In early December
2012, Omeros reported promising data from the
single-ascending-dose (SAD) study portion of a phase I study
The positive data has led Omeros to advance OMS824 into the
next stage of the phase I clinical trial - the evaluation of
multiple-dose administration of the compound. Omeros expects to
report additional data from its phase I program for candidate
OMS824 in the first quarter of 2013.
We currently have a Neutral recommendation on Omeros, which
carries a Zacks #3 Rank (Hold). Right now,
) looks attractive with a Zacks #1 Rank (Strong Buy).
OMEROS CORP (OMER): Free Stock Analysis
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