Many people in their early to mid-40s experience age-related farsightedness, or presbyopia, that’s most often managed with eyeglasses, contact lenses. But now a medicine to treat this condition—which makes it harder for individuals to focus on nearby objects—is undergoing review for approval by the Food and Drug Administration (FDA) with a decision expected by the end of this year, reports fiercebiotech.com.
For the Phase III clinical trial conducted by pharmaceutical company AbbVie, researchers evaluated 323 men and women ages 40 to 55 with age-related farsightedness after they received a once-daily dose of a medication called AGN-190584—administered as a drop in both eyes—or a placebo for 30 days.
Results showed that at the third hour on the last day of the trial a statistically significant number of individuals who were treated with the medicine were able to read at least three more lines on a chart in low light than before the treatment.
“Building upon our heritage in eye care, we are proud to be leading the development of a first-of-its-kind potential treatment option for those living with presbyopia. If approved by the FDA, AGN-190584 is expected to be the first eye drop specifically designed for presbyopia,” said Michael R. Robinson, MD, the vice president of global therapeutic area head and eye care at AbbVie.
According to Robinson, the med became effective after 15 minutes and improved individuals’ near and intermediate vision without affecting their distance vision.
In addition, researchers noted that 75% of those who received the ophthalmic solution were able to clearly see at least two more lines on the reading test chart than they were prior to the treatment. What’s more, 93% of those in the study achieved no less than 20/40 acuity on a vision test in daylight.
Scientists noted no harmful effects among participants. The most common side effect reported was headache, which was temporary.