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Allergan Plc

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Allergan to Share New Data Highlighting Latest Advancements in Eye Care at ARVO 2021 Annual Virtual Meeting

Details:

The company will present patient-reported outcomes for AGN-190584, an investigational therapy for the treatment of presbyopia. Recently the company submitted an NDA to the U.S. Food and Drug Administration based on data from the Phase 3 GEMINI 1 and GEMINI 2 clinical trials.

Lead Product(s): Pilocarpine Hydrochloride

Therapeutic Area: Ophthalmology Product Name: AGN-190584

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: AbbVie Inc

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 27, 2021

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Allergan Plc

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Allergan, an AbbVie Company, Submits New Drug Application for Investigational AGN-190584 for the Treatment of Presbyopia

Details:

Allergan has submitted a New Drug Application to the U.S. Food and Drug Administration for investigational AGN-190584 (pilocarpine 1.25%) ophthalmic solution for the treatment of presbyopia. The FDA is expected to act on the NDA by the end of 2021.

Lead Product(s): Pilocarpine Hydrochloride

Therapeutic Area: Ophthalmology Product Name: AGN-190584

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: AbbVie Inc

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable February 25, 2021

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Allergan Plc

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Allergan, an AbbVie Company, to Share New Data at American Academy of Ophthalmology (AAO) 2020 Virtual

Details:

Data presented at the meeting will include an analysis examining the safety and efficacy of DURYSTA™ and a second analysis of data from the Phase 3 ARTEMIS studies that identify different characteristics of glaucoma patients who may respond after being treated with DURYSTA™.

Lead Product(s): Pilocarpine Hydrochloride

Therapeutic Area: Ophthalmology Product Name: AGN-190584

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable November 06, 2020

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Allergan Plc

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Allergan, an AbbVie Company, Announces Positive Phase 3 Topline Results for Investigational AGN-190584 for the Treatment of Presbyopia

Details:

Phase 3 GEMINI 1 and 2 studies evaluating AGN-190584 (pilocarpine 1.25%) ophthalmic solution met the primary endpoint, reaching statistical significance in improvement in near vision.

Lead Product(s): Pilocarpine Hydrochloride

Therapeutic Area: Ophthalmology Product Name: AGN-190584

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: AbbVie Inc

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable October 28, 2020

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Allergan Plc

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Molecular Partners Provides Regulatory Update of European and Japanese Filings of Abicipar Pegol

Details:

Allergan, an AbbVie has informed Molecular Partners of their intent to withdraw application filings with both the EMA and the Japanese Regulatory Agency (PMDA) for abicipar pegol, a novel DARPin therapeutic for patients with neovascular (wet) age-related macular degeneration.

Lead Product(s): Abicipar Pegol

Therapeutic Area: Ophthalmology Product Name: Abicipar

Highest Development Status: Phase III Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 20, 2020

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Allergan Plc

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Allergan to Present New Data for Investigational Bimatoprost Sustained-Release at American Glaucoma Society Annual Meeting

Details:

A New Drug Application (NDA) for Bimatoprost SR is currently under review with the U.S. Food and Drug Administration, and if approved, has the potential to be the first and only biodegradable.

Lead Product(s): Bimatoprost

Therapeutic Area: Ophthalmology Product Name: Undisclosed

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable February 25, 2020

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