Eyeing quick approval, AbbVie offers a close-up on their presbyopia drug data
AbbVie picked up some bonus points earlier this year as one of its pipeline adds from the $63 billion Allergan buyout hit its top-line marks. And now the researchers have produced the detailed data on the case they are making with regulators, with an eye on a major new market and a hoped-for approval before New Year’s.
AGN-190584 is aiming to be the first easy-on eyedrop for presbyopia, a common ailment for large numbers of people who find it harder and harder to read things like a watch or cell phone close up. Anyone who’s held a book out at arm’s length in order to read it will be very familiar with the condition, if not the exact diagnosis.
Their Phase III study — Gemini I — came up with some convincing proof that the eyedrops deliver fast though transient improvements in reading ability, with a statistically significant group of patients adding 3 lines or more when viewing a reading chart.
AbbVie’s team turned up at the 2021 American Society of Cataract and Refractive Surgery annual meeting to showcase the data, which includes a generally clean bill of health on safety.
“While not often known by name, the 128 million Americans living with presbyopia feel the condition’s impact throughout their daily lives, often when looking at their cell phones, reading or trying to see a menu in a dimly lit restaurant. Additionally, our ever-increasing time spent on digital devices, from smartwatches to smartphones, has put unprecedented demands on our vision,” said George O. Waring IV, the GEMINI principal study investigator.
Here’s a breakout:
The primary and key secondary endpoints were met with a statistically significant greater proportion of participants treated with AGN-190584 who gained three lines or more (the ability to read three additional lines on a reading chart) in mesopic (in low light), high contrast, binocular Distance Corrected Near Visual Acuity (DCNVA) at Day 30, Hour 3 (22.5%, p < 0.0001) and Hour 6 (9.7%, p = 0.0114) versus the vehicle. The results demonstrated AGN-190584 had a rapid onset of 15 minutes and duration of up to six hours in mesopic DCNVA without loss of distance vision after administration at Day 30. Additional endpoints evaluated showed that 75% of participants treated with AGN-190584 achieved a ≥2-line improvement in mesopic DCNVA; and 93% of participants achieved ≥20/40 vision in photopic (daylight) DCNVA. Improvements were also observed in Distance Corrected Intermediate Visual Acuity (DCIVA) for up to 10 hours at Day 30.