Oculus Innovative Sciences, Inc.
) recently announced the commencement of patient enrolment for its
double-blind, randomized clinical study on Microcyn hydrogel. The
study will be evaluating advanced Microcyn hydrogel for the
management of hypertrophic or keloid scars under a protocol
reviewed by the US Food and Drug Administration (FDA).
Oculus will be enrolling 40 patients across four different US
sites. After completing the trial, Oculus expects to submit
top-line data to the FDA, to support its pre-market notification
clearance (510k application), by mid-2013.
Oculus will be receiving an upfront milestone payment following
the FDA pre-market notification clearance from its dermatology
partner, AmDerma/Quinnova. This milestone payment will reimburse
Oculus for the costs incurred on the trial.
Notably, in July this year, Oculus received regulatory approval
from the Chinese State Food and Drug Administration (SFDA) for its
Microcyn hydrogel for moistening, repairing and healing of acute
and chronic wounds. The Chinese approval was followed by the
successful completion of randomized trials in a few major Chinese
hospitals on the use of Microcyn hydrogel.
Apart from Microcyn hydrogel, Oculus was also in the news for an
exclusive licensing agreement earlier this month. The company
announced the licensing of its Microcyn-based human healthcare
products in Mexico, South/Central America and the Caribbean to More
Pharma Corporation for an upfront milestone payment of $5.1
As per the agreement, More Pharma will begin marketing and
selling the products in Mexico immediately, while the same in other
areas depends on securing the necessary regulatory clearances.
Moreover, More Pharma will be responsible for all costs regarding
the regulatory review and approval.
We currently have a Neutral recommendation on Oculus. The stock
carries a Zacks #2 Rank (Buy rating) in the short run.
OCULUS INNOVATV (OCLS): Free Stock Analysis
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