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Allergan, an AbbVie Company, to Present New Data on Investigational AGN-190584 for the Treatment of Presbyopia

10/26/2021 | 08:30am EST

Allergan, an AbbVie company, 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. 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. 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. Allergan has discovered, developed, and delivered some of the most innovative products in the industry for more than 70 years. Allergan has launched over 125 eye care products and invested billions of dollars in treatments for the most prevalent eye conditions including glaucoma, ocular surface disease, and retinal diseases such as diabetic macular edema and retinal vein occlusion.

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Financials (USD)
Sales 2020 15 208 M - -
Net income 2020 - - -
Net Debt 2020 - - -
P/E ratio 2020 -
Yield 2020 -
Capitalization 63 649 M 63 649 M -
Capi. / Sales 2020 4,19x
Capi. / Sales 2021 4,02x
Nbr of Employees 17 400
Free-Float -
Income Statement Evolution
Managers and Directors
Robert A. Michael President & Director
Scott Reents Director
Ryan Quigley Director
Andres Rodrigo Director
Basil Blakeney Director
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