CSBio CSBio

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2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Graphite Bio"},{"orgOrder":0,"company":"Tarsier Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Tarsier Pharma Announces Successful Type C Meeting with FDA for TRS01 in Noninfectious Uveitis","therapeuticArea":"Ophthalmology","highestDevelopmentStatus":"Phase III","country":"ISRAEL","productType":"Small molecule","productStatus":"New Molecular Entity","date":"November 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Tarsier Pharma"},{"orgOrder":0,"company":"Kodiak Sciences","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Kodiak Reboots Tarcocimab Tedromer Development Program Following Strong Positive Results in Phase 3 Diabetic Retinopathy Glow Study and Following Dialogue with US Regulatory Authorities on A Regulatory Pathway for BLA Submission","therapeuticArea":"Ophthalmology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"November 2023","url1":"","url2":"","graph1":"Large molecule","graph2":"Kodiak Sciences"},{"orgOrder":0,"company":"Outlook Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Outlook Therapeutics\u00ae Provides Update on Type A Meetings with FDA","therapeuticArea":"Ophthalmology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Large molecule","productStatus":"Approved","date":"November 2023","url1":"","url2":"","graph1":"Large molecule","graph2":"Outlook Therapeutics"},{"orgOrder":0,"company":"LianBio","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"LianBio Announces Topline Results from Phase 3 LIBRA Trial of TP-03 in Chinese Patients with Demodex Blepharitis","therapeuticArea":"Ophthalmology","highestDevelopmentStatus":"Phase III","country":"CHINA","productType":"Small molecule","productStatus":"New Molecular Entity","date":"October 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"LianBio"},{"orgOrder":0,"company":"Ocular Therapeutix","sponsor":"Jefferies","pharmaFlowCategory":"D","amount":"$100.1 million","upfrontCash":"Undisclosed","newsHeadline":"Ocular Therapeutix Announces Pricing of Public Offering of Common Stock","therapeuticArea":"Ophthalmology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"December 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Ocular Therapeutix"},{"orgOrder":0,"company":"Ocular Therapeutix","sponsor":"Jefferies","pharmaFlowCategory":"D","amount":"$115.1 million","upfrontCash":"Undisclosed","newsHeadline":"Ocular Therapeutix Announces Closing of Public Offering of Common Stock and Full Exercise by Underwriters of Option to Purchase Additional Shares","therapeuticArea":"Ophthalmology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"December 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Ocular Therapeutix"},{"orgOrder":0,"company":"Stuart Therapeutics","sponsor":"Ora, Inc","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Stuart Therapeutics Announces First Patient, First Visit in Its Phase 3 Clinical Trial of Vezocolmitide for Dry Eye Disease","therapeuticArea":"Ophthalmology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"December 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Stuart Therapeutics"},{"orgOrder":0,"company":"Ocuphire Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Ocuphire Pharma Receives FDA Agreement Under Special Protocol Assessment for LYNX-2 Phase 3 Trial of Phentolamine Ophthalmic Solution for the Treatment of Decreased Visual Acuity under Dim (mesopic) Light Conditions","therapeuticArea":"Ophthalmology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"January 2024","url1":"","url2":"","graph1":"Small molecule","graph2":"Ocuphire Pharma"},{"orgOrder":0,"company":"Alvotech","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Alvotech Clinical Study Results Demonstrate Therapeutic Equivalence between Biosimilar Candidate AVT06 and Reference Product Eylea\u00ae (aflibercept)","therapeuticArea":"Ophthalmology","highestDevelopmentStatus":"Phase III","country":"ICELAND","productType":"Large molecule","productStatus":"Biosimilar","date":"January 2024","url1":"","url2":"","graph1":"Large molecule","graph2":"Alvotech"},{"orgOrder":0,"company":"Bausch & Lomb Incorporated","sponsor":"Eyenovia","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"$5.0 million","newsHeadline":"Eyenovia Re-Acquires Development and Commercialization Rights to MicroPine in the U.S. and Canada","therapeuticArea":"Ophthalmology","highestDevelopmentStatus":"Phase III","country":"CANADA","productType":"Small molecule","productStatus":"Approved","date":"January 2024","url1":"","url2":"","graph1":"Small molecule","graph2":"Bausch & Lomb Incorporated"},{"orgOrder":0,"company":"Outlook Therapeutics","sponsor":"Great Point Partners","pharmaFlowCategory":"D","amount":"$172.0 million","upfrontCash":"Undisclosed","newsHeadline":"Outlook Therapeutics\u00ae Receives FDA Agreement Under Special Protocol Assessment (SPA) for 90 Day Non-Inferiority Study, NORSE EIGHT, and Announces Private Placement of Up to $172 Million to Advance ONS-5010","therapeuticArea":"Ophthalmology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Large molecule","productStatus":"Approved","date":"January 2024","url1":"","url2":"","graph1":"Large molecule","graph2":"Outlook Therapeutics"},{"orgOrder":0,"company":"Ocular Therapeutix","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Ocular Therapeutix\u2122 Announces FDA Agreement to Amend Special Protocol Assessment (SPA) for Pivotal Clinical Trial of AXPAXLI\u2122 in Wet AMD","therapeuticArea":"Ophthalmology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"January 2024","url1":"","url2":"","graph1":"Small molecule","graph2":"Ocular Therapeutix"},{"orgOrder":0,"company":"Outlook Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not 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Applicable","newsHeadline":"Ocular Therapeutix Announces First Subjects Screened in Phase 3 Pivotal Clinical Trial of AXPAXLI in Wet AMD","therapeuticArea":"Ophthalmology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"February 2024","url1":"","url2":"","graph1":"Small molecule","graph2":"Ocular Therapeutix"},{"orgOrder":0,"company":"Opthea","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Opthea Completes Enrollment in First Pivotal Trial with Sozinibercept","therapeuticArea":"Ophthalmology","highestDevelopmentStatus":"Phase III","country":"AUSTRALIA","productType":"Large molecule","productStatus":"New Molecular Entity","date":"February 2024","url1":"","url2":"","graph1":"Large molecule","graph2":"Opthea"},{"orgOrder":0,"company":"AffaMed Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"AffaMed Therapeutics Announces New Drug Application Acceptance by Singapore Health Sciences Authority (HSA) for DEXTENZA\u00ae for Treatment of Ocular Inflammation and Pain Following Ophthalmic Surgery, and Ocular Itching Associated with Allergic Conjunctiviti","therapeuticArea":"Ophthalmology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"February 2024","url1":"","url2":"","graph1":"Small molecule","graph2":"AffaMed Therapeutics"},{"orgOrder":0,"company":"Ocular Therapeutix","sponsor":"Venrock Healthcare Capital Partners","pharmaFlowCategory":"D","amount":"$325.0 million","upfrontCash":"Undisclosed","newsHeadline":"Ocular Therapeutix, Inc. Announces $325.0 Million Private Placement","therapeuticArea":"Ophthalmology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"February 2024","url1":"","url2":"","graph1":"Small molecule","graph2":"Ocular Therapeutix"}]

Find Clinical Drug Development Pipelines & Deals | PipelineProspector

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            Details:

            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.

            Lead Product(s): Ranibizumab

            Therapeutic Area: Ophthalmology Product Name: Ranivisio

            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 June 23, 2022

            Details:

            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.

            Lead Product(s): Ranibizumab

            Therapeutic Area: Ophthalmology Product Name: CHS-201

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: MS Pharma

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Licensing Agreement December 14, 2021

            Details:

            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.

            Lead Product(s): Ranibizumab

            Therapeutic Area: Ophthalmology Product Name: CHS-201

            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 August 06, 2021

            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

            Abbvie CB

            TMF Summit 2024

            Not Confirmed

            envelop Contact Supplier

            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

            Abbvie CB

            TMF Summit 2024

            Not Confirmed

            envelop Contact Supplier

            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

            Abbvie CB

            TMF Summit 2024

            Not Confirmed

            envelop Contact Supplier

            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

            Abbvie CB

            TMF Summit 2024

            Not Confirmed

            envelop Contact Supplier

            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

            Abbvie CB

            TMF Summit 2024

            Not Confirmed

            envelop Contact Supplier

            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

            Abbvie CB

            TMF Summit 2024

            Not Confirmed

            envelop Contact Supplier

            Details:

            The company intends to use the net proceeds from the private placement to accelerate the clinical development of Axpali (axitinib) for the treatment of wet age-related macular degeneration.

            Lead Product(s): Axitinib

            Therapeutic Area: Ophthalmology Product Name: Axpaxli

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Venrock Healthcare Capital Partners

            Deal Size: $325.0 million Upfront Cash: Undisclosed

            Deal Type: Private Placement February 22, 2024

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