Oculus hydrogel treatment for scars receives regulatory OK in Mexico

Oculus Innovative Sciences announced it has received regulatory approval in Mexico for its hydrogel treatment for hypertrophic and keloid scars.

The Microcyn-based hydrogel will be marketed under the brand name Epicyn, according to a press release. A commercial launch is planned in the summer. Microcyn Scar Management HydroGel received FDA 510(k) clearance earlier this month.

“This is the first of many opportunities for our new scar management hydrogel formulation outside the United States,” Bruce Thorton, executive vice president of Oculus, said in the release. “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.”

More Pharma plans a clinical study, similar to the one conducted in the US for the FDA, in conjunction with Oculus. The safety and efficacy of Epicyn will be compared to the current standard of scar management in Mexico, which could provide key opinion leaders with data to support the adoption of the new treatment, the release said.

“This new scar management hydrogel will simply build upon this established legacy of safety and success in Mexico,” Guillermo Ibarra, More Pharma’s chief executive officer, said in the release. “We look forward to bringing doctors and patients in Mexico, Central America, Caribbean and other Latin American countries a genuine advance in the management of scars.”