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Lead Product(s): Pilocarpine
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
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.
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Lead Product(s): Pilocarpine
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
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™.
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Lead Product(s): Pilocarpine
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
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.
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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
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.
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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
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.
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