Allergan, an AbbVie (NYSE: ABBV) company, today announced that it will present new pooled analyses and post hoc results from the Phase 3 trials of AGN-190584 (pilocarpine HCl ophthalmic solution 1.25%), an investigational novel treatment for presbyopia, at Academy 2021, the annual meeting of the American Academy of Optometry, November 3-6. Presentations will include clinical results for near and intermediate vision, functional near vision, efficacy for post-LASIK patients, and the patient experience.
“We look forward to sharing data from AGN-190584’s Phase 3 study results with attendees at Academy 2021 that not only show an improvement in near vision in presbyopia patients, but also shed light on how practitioners may implement this treatment in the real world, pending approval,” said Michael R. Robinson, M.D., vice president, global therapeutic area head, eye care, AbbVie. “Optometrists well understand the daily challenges of those living with age-related blurry near vision called presbyopia, a progressive vision condition that affects nearly all of us as we age. Building upon our heritage of innovation in eye care, we look forward to the potential of bringing forth a completely new treatment option for eye care professionals to offer their patients.”
Investigational AGN-190584 was specifically designed for the treatment of presbyopia. An optimized formulation of pilocarpine 1.25% with pHast™ technology was selected after the development of this proprietary vehicle and rigorous testing of 16 formulations. A New Drug Application was submitted to the U.S. Food and Drug Administration earlier this year and full Phase 3 GEMINI 1 study results were announced in July. Allergan, an AbbVie Company, intends to market the treatment as VUITY™ (pilocarpine HCl ophthalmic solution 1.25%) pending FDA approval.
Abstracts for Academy 2021 can be viewed on the Academy website HERE.
Posters are listed below and will be displayed all day November 4, 2021. Authors will be present from 4:30 pm to 6:30 pm ET for questions.
- AGN-190584 Improves Intermediate Vision in Pooled Phase 3 GEMINI 1 and 2;
- Comparison of Participants with and without LASIK in Near Vision Improvement with AGN-190584 Treatment;
- Near Vision Line Improvement Stratified by Baseline Severity with AGN-190584 in Pooled Phase 3 GEMINI 1 and 2;
- Pooled Phase 3 GEMINI 1 and 2: AGN-190584 Improves Functional Near Vision;
- Interpreting Clinically Meaningful Near Vision Improvement in Presbyopia With AGN-190584 in the Gemini 1 Phase 3 Trial;
- GEMINI I and 2 Patient Experience with the Use of AGN-190584 (Pilocarpine 1.25%) for Presbyopia
About the Phase 3 Studies
GEMINI 1 and GEMINI 2 enrolled a total of 750 patients randomized in a one-to-one ratio of vehicle (placebo) to AGN-190584 (pilocarpine HCl ophthalmic solution 1.25%). Both studies met the primary endpoint, achieving statistical significance compared to vehicle in improvement in mesopic (low light) near vision on Day 30, Hour 3 without compromising distance vision. AGN-190584 was administered in each eye once-daily, for 30 days in both GEMINI 1 and GEMINI 2 participants with presbyopia. There were no treatment emergent serious adverse events observed in any AGN-190584 treated participants. The most common adverse reactions reported in >5% of patients were headache and conjunctival hyperemia. The majority of secondary endpoints were also met in both studies, including a significant improvement vs. vehicle in patient-reported outcomes (PROs) such as an increase in vision-related reading ability, and reductions in the impact of presbyopia on daily life and use of coping behaviors to manage presbyopia.
AGN-190584 is an investigational, novel optimized formulation of pilocarpine specifically designed for the treatment of presbyopia as a topical, once-daily drop delivered with pHast™ technology, a proprietary vehicle. This allows AGN-190584 to rapidly adjust to the physiologic pH of the tear film. The primary mechanism of action is through pupil constriction to improve near and intermediate vision while maintaining some pupillary response to different lighting conditions – an effect known as dynamic pupil modulation.