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Find Clinical Drug Development Pipelines & Deals | PipelineProspector
The active substance of Ranivisio is ranibizumab, a monoclonal antibody fragment (ATC code: S01LA04) which modulates angiogenesis by inhibiting vascular endothelial growth factor A. Ranivisio is a biosimilar medicinal product.
Under the exclusive agreement, MS Pharma will be responsible for the registration and commercialization of FYB201/CHS-201 (Ranibizumab), in the Middle East and North African countries. MS Pharma will start the registration procedures in MENA immediately.
CHS-201 (ranibizumab), trade name Lucentis® among others is a monoclonal anti-angiogenic antibody fragment (Fab) that has been approved to treat the "wet" type of age-related macular degeneration a common form of age-related vision loss.
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.
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.
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™.
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.
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.
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.
MTP-131 (elamipretide) is an investigational mitochondrial-targeting peptide agent, which is being evaluated for the treatment of dry age-related macular degeneration.
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