Oculus Innovative Sciences, a global healthcare company, has obtained an approval from the Mexican Ministry of Health for its Microcyn-based scar management hydrogel for the care of keloid and hypertrophic scars
The hydrogel will be marketed under the brand name of Epicyn.
In preparation for a commercial launch in the summer 2014, More Pharma, together with Oculus, plans to conduct an additional clinical study to evaluate the safety and efficacy profile of Epicyn relative to the current standard of scar management in Mexico.
The study, which is expected to be initiated in the first half of 2014, will be similar to the one the company conducted in the US.
Oculus Innovative Sciences executive vice president Bruce Thornton noted from a corporate perspective, this is just the first of many opportunities for the company’s new scar management hydrogel formulation outside the US.
"In addition to the approval by the Mexican Ministry of Health, our Latin American partner, More Pharma, in parallel with the introduction of the new Epicyn Scar Hydrogel in the Mexican dermatology market, intends to move forward to secure regulatory approvals, and subsequent product launches, in additional Latin American countries as well.
"We are exceedingly proud of our teams in both Mexico and the United States for working in tandem to secure respective regulatory approvals," Thornton added.
Oculus has recently obtained 510(k) clearance from the US Food and Drug Administration for the Microcyn scar management hydrogel.