MeiraGTx announces FDA breakthrough therapy designation for AAV2-hAQP1

“We are delighted to have been awarded Breakthrough Designation for our AAV2-hAQP1 treatment for Grade 2 and Grade 3 late xerostomia caused by radiotherapy for cancers of the upper aerodigestive tract,” said Alexandria Forbes, president and chief executive officer of MeiraGTx (MGTX). “This Breakthrough application was supported by 3-year data from the Phase 1 dose escalation study. On April 16th, we will be providing an AAV2-hAQP1 program update with information about the commercial opportunity for this therapy, as well as presenting the 3-year data. We have also had huge enthusiasm about our Phase 2 AQUAx2 study in the RIX community, amongst physicians and patients.”