logo
  

Eyenovia Announces NDA Submission For MydCombi - Quick Facts

Eyenovia, Inc. (EYEN) has submitted a New Drug Application to the U. S. FDA for MydCombi, a fixed combination pupil dilation agent. The NDA submission was based on the MIST-1 and MIST-2 studies. The NDA submission follows the initial enrollment of the VISION-1 study, phase 3 study for MicroLine in presbyopia, with top-line data expected the first half of 2021.

"The NDA application is the first of our three late-stage programs to complete Phase 3 studies leading to this FDA submission. If approved, MydCombi could be available late next year or early 2022 and improve a common clinical practice that has not advanced in nearly a century," said Sean Ianchulev, CEO of Eyenovia.

For comments and feedback contact: editorial@rttnews.com

Business News

Editors Pick
American Honda Motor Co, Inc. has recalled about 2,900 units of 2022 model year Honda TRX90X All-Terrain Vehicles (ATVs) sold in the United States for possible crash and injury hazard, according to a statement issued by the U.S. Consumer Product Safety Commission or CPSC. The Laundress, a unit of Conopco Inc. d/b/a Unilever, is recalling around 8 million laundry and household cleaning products citing risk of exposure to bacteria, U.S. Consumer Product Safety Commission. The recall involves Laundress laundry detergent, fabric conditioner and other cleaning products. Tesla Inc. has delivered its first Semi, a heavy-duty electric truck, to its customer PepsiCo Inc. during an event at its Nevada Gigafactory. The delivery of 500-mile fully electric Semi truck comes five years after the launch of the truck's prototype in 2017. During Thursday night's Semi Delivery Event at Tesla's Sparks, Nevada factory, CEO Elon Musk, with Dan Priestly, ...
Follow RTT