Oculus Innovative Sciences, Inc. (OCLS) 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 million.
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.
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