FDA accepts IND application for Aerie dry eye disease candidate
The FDA has accepted an investigational new drug application for AR-15512, an eye drop intended to treat dry eye disease, according to a press release from Aerie Pharmaceuticals.
AR-15512, a TRPM8 agonist formerly known as AVX-012, was acquired by Aerie in November 2019 with the acquisition of Avizorex Pharma. The drop regulates tear production and blink rate, thereby restoring tear film volume in patients with dry eye disease.
“The acceptance of the IND for AR-15512 marks the first clinical-stage dry eye product candidate for Aerie, another important milestone for the company. We expect to commence a phase 2b clinical study, which will be powered as a phase 3, later this year, with a topline readout expected in the third quarter of 2021,” Vicente Anido Jr., PhD, chairman and CEO of Aerie, said in the release.
Avizorex previously completed a phase 2a study with positive results.
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