) recently announced that it successfully completed the 90-day
safety database lock for the second of its two phase III studies
on OMS302. OMS302 is being developed for use in patients
undergoing intraocular lens replacement surgery.
The candidate was well tolerated, though both OMS302 and
placebo had a similar incidence of adverse events.
OMS302 is intended to maintain intraoperative mydriasis (pupil
dilation) and lessen postoperative pain and irritation due to
cataract and other lens replacement surgery.
In Nov 2012, Omeros had reported positive data from the study
on OMS302. Results from the study showed that OMS302 achieved
statistically significant maintenance of intraoperative mydriasis
as well as reduction of pain in the early postoperative
Omeros plans to submit a New Drug Application (NDA) for the
candidate in the US soon. The company also has plans to submit a
Marketing Authorization Application for OMS302 to the European
Medicines Agency in mid-2013. the company expects to launch the
product in the first half of 2014.
We note that the eye market currently has players like
Regeneron Pharmaceuticals Inc.
Meanwhile, we remind investors that Omeros reported mixed
results last month on its other pipeline candidate, OMS103HP,
from its first pivotal phase III study that was being conducted
in patients undergoing arthroscopic partial meniscectomy
OMS103HP 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.
Omeros carries a Zacks Rank #3 (Hold). Right now,
) looks more attractive with a Zacks Rank #2 (Buy).
BAYER A G -ADR (BAYRY): Free Stock Analysis
OMEROS CORP (OMER): Free Stock Analysis
REGENERON PHARM (REGN): Free Stock Analysis
TARGACEPT INC (TRGT): Free Stock Analysis
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