AbbVie has shared full results from a phase 3 trial it is hoping will persuade the FDA to approve a medicine solution for age-related far-sightedness, which is typically treated with contacts or glasses.
The study of AGN-190584, or pilocarpine formulation, showed significant improvements in the vision of patients with age-related far-sightedness after 30 days of dosing.
In October, Allergan, part of AbbVie, revealed two phase 3 trials of AGN-190584 met their primary endpoints, teeing it up to file for FDA approval. With a decision due by the end of 2021, AbbVie shared a closer look at the results of one of the late-phase studies at this year’s American Society of Cataract and Refractive Surgery annual meeting.
The 323-patient clinical trial assessed participants after 30 days of dosing with either AGN-190584 or placebo. At hour three on day 30, AbbVie linked AGN-190584 to a statistically significant increase in the proportion of subjects who experienced a three-line or greater improvement on a low-light reading chart test, causing the trial to hit its primary endpoint with a p value of less than 0.0001.
AGN-190584 began working in 15 minutes and lasted for up to six hours without a loss of distance vision after administration on day 30, AbbVie said in a statement. The difference in the response rate in the cohorts diminished by hour six, although the p value at that time point was still a statistically significant 0.0114.
Data for other endpoints showed that 75% of patients treated with AGN-190584 experienced at least a two-line improvement on the low-light reading test. Ninety three percent of participants had at least 20/40 vision on a daylight vision test.
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AbbVie saw no treatment-emergent serious adverse events in recipients of AGN-190584. The most common treatment-emergent non-serious adverse event was headache, which affected more than 5% of people. AbbVie said most side effects were mild and transient, adding that 1.2% of patients discontinued due to adverse events.
The data drop sheds light on the results AbbVie hopes will secure FDA approval in presbyopia, the medical name for the condition that makes it more difficult for people to focus on objects close to them over the age of 40 years. Today, people wear reading glasses or contact lenses to manage the condition but companies including AbbVie and Eyenovia see an opportunity for medicines.