The estimated median duration of ≥1 line gained was greater than 9 hours on both study day 1 and day 30 in patients with presbyopia treated with the study agent.
New research suggest patients with presbyopia treated with pilocarpine ophthalmic solution 1.25% (AGN-190584) acquired ≥3-, ≥2-, and ≥1-line gains in photopic distance-corrected intermediate visual acuity (DCIVA) during 10-hour visits on study days 1 and 30
Moreover, the estimated duration of the line gains was longer on day 30 than day 1, which may suggest the efficacy of the ophthalmic solution increases with continued usage.
“These findings indicate that the pilocarpine eye drops improve intermediate vision under bright light over 10 hours on both Day 1 and 30 of administration,” wrote study author Daniel Chang, MD, Empire Eye and Laser Center.
These findings were presented at the Association of Research in Vision and Ophthalmology (ARVO) 2022 Meeting in Denver, Colorado.
Pilocarpine ophthalmic solution 1.25% was recently FDA approved for the treatment of presbyopia. It contracts the iris sphincter muscle, constricting the pupil to improve near and intermediate visual acuity while maintaining pupillary response to light and additionally contracts the ciliary muscle and may shift the eye to a more myopic state.
Both phase 3 GEMINI studies evaluated efficacy and safety of the solution administered bilaterally once daily for 30 days in participants with presbyopia. Those with presbyopia (40 - 55 years) were randomized to Pilo 1.25% (n = 375) or vehicle (n = 375) once daily at 8am in both eyes for 30 days.
Investigators assessed intermediate visual acuity at a distance of 66 cm. The number of individuals treated with Pilo 1.25% who achieved ≥3, ≥2, and ≥1-line gains in photopic DCIVA from baseline at 10-hour study visit on day 1 and 30 was determined.
Additionally, Kaplan-Meier analysis was used to estimate the duration of the ≥3, ≥2, and ≥1-line gains in DCIVA. For each day and level of DCIVA gain, the number of participants at risk at time 0 was the total number achieving DCIVA gain, time 0 was the time of the individual’s first achievement of the DCIVA gain, and the event was failure to maintain the DCIVA gain.
Data show on day 1, a total of 60 (16.0%) study participants in the Pilo 1.25% treatment group achieved ≥3-line gain, 158 (42.1%) at least ≥2-line gain, and 300 (80.0%) ≥1-line gain in photopic DCIVA, compared to baseline. Investigators noted day 1, hour 1 was the first time point with a potential improvement from baseline, with the maximum measured duration of DCIVA gains on Day 1 at 9 hours.
Further, the Kaplan-Meier estimates of the median duration of sustained DCIVA improvement on day 1 were 5 hours for ≥3-line gains, 7 hours for ≥2-line gains, and over 9 hours and beyond the 10-hour study visit duration for ≥1-line gains.
Then, on day 30, data show 96 (25.6%) study participants in the active treatment cohort attiained ≥3-line gain, 205 (54.7%) ≥2-line gain, and 312 (83.2%) ≥1-line gain in photopic DCIVA compared with baseline.
Investigators noted the Kaplan-Meier estimates of the median duration of sustained DCIVA improvement were 7 hours for ≥3-line gains, 8 hours for ≥2-line gains, and over 10 hours and beyond the study visit duration for ≥1-line gains.
The study, “Duration of Efficacy of AGN-190584 on Photopic Distance-Corrected Intermediate Visual Acuity in the GEMINI 1 and GEMINI 2 Pooled Phase 3 Studies,” was presented at ARVO 2022.