Understanding Perspectives on Presbyopia and Use of Pilocarpine HCl 1.25% Twice Daily from Participants of the Phase 3 VIRGO Study.

Abstract

The phase 3, randomized, vehicle-controlled, 14-day VIRGO study evaluated the efficacy and safety of twice-daily dosing of pilocarpine hydrochloride ophthalmic solution 1.25% (Pilo) in presbyopia. On VIRGO exit, a companion study was conducted to assess the patient experience with presbyopia and satisfaction with Pilo. Recruited individuals completed the Presbyopia Patient Satisfaction Questionnaire (PPSQ) plus a three-part exit survey, or a live interview. The PPSQ evaluated respondents' experience with Pilo. Survey parts 1 and 2 evaluated experience managing presbyopia before and during VIRGO, respectively; part 3 assessed future possibilities of using Pilo in real-world situations. The interview further informed the interviewees' experience with presbyopia and Pilo. The primary endpoint was responders (%) in each rating category of the PPSQ items 1-7; the secondary endpoints were summary of categorical (survey) and qualitative (interviews) responses. The PPSQ and survey included 62 participants who received Pilo (N = 28) or vehicle (N = 34) in VIRGO; the interview included ten participants (Pilo, N = 4; vehicle, N = 6). Per the PPSQ, 64.3% of Pilo users reported vision improvement, including 17.9% with complete improvement; ≥ 46.4% were satisfied/very satisfied with their ability to perform daily activities, see up close unaided, and read in dim light. Among vehicle users, these percentages were 35.3%, 0%, and ≤ 23.5%, respectively. In both subgroups, ≥ 67.9% were interested in using Pilo or Pilo and eyeglasses/contact lenses in the future. Per the interview, vehicle users (n = 6/6) found the eyedrop easy to use but none experienced meaningful near-vision improvements, stopped using other correction method(s) part of the day, were satisfied with the eyedrop, preferred it over their previous correction method(s), or would continue using it if prescribed. Conversely, 75% (n = 3/4) of Pilo users responded positively to each of these six criteria. Findings validate the VIRGO results and improve our understanding of the patient experience, demonstrating improved vision and satisfaction with Pilo (vs. vehicle) when performing daily activities.