Pediapharm Inc. (CVE:PDP) said today that it won regulatory approval from Health Canada for its Otixal eye drop solution for the treatment of acute otitis media with tympanostomy tubes in pediatric patients.

The Quebec-based company touts Otixal as the 1st antibiotic and steroid combination ear drop available in single, sterile unit-dose packaging. Otitis media, or middle ear inflammation, is 1 of the most common pediatric infections in Canada, according to Pediapharm. Tympanostomy tubes can be inserted in the eardrum to drain fluid from the middle ear in children with recurrent acute otitis media.

“The most common symptom of AOMT for many children is fluid drainage from the ear (otorrhea) and having a new medication to treat those children is more than welcome,” Dr. Peter Spafford, president of the Canadian Society of Otolaryngology – Head & Neck Surgery, explained. “Additionally, delivering drops into children’s ears is not always easy for parents. Otixal’s unique single-use, premeasured dosing helps assure an accurate dose every time. This will certainly help parents to be more compliant with the medication.”

“Otixal represents a great opportunity to introduce innovation in a growing market that has not seen innovation for years” Pediapharm’s VP of sales & marketing Richard Labelle said in prepared remarks. “Given its strong medical evidence and unique delivery mode, Otixal has the potential to significantly improve the quality of life of many young patients who have undergone tympanostomy tube insertion and are suffering from acute otitis media”

“We are very pleased with the approval of Otixal, which represents the 2nd Health Canada approval within six months for us” president & CEO Sylvain Chretien added. “With our strong infrastructure in place and with our track record in successfully launching drugs, we are very confident in our ability to make Otixal a success in Canada.”