All Data
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Lead Product(s): Thymosin Beta-4
Therapeutic Area: Ophthalmology Product Name: RGN-259
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 October 28, 2020
Details:
ARISE-3 is designed to assess the safety and efficacy of 0.1% RGN-259 eye drops compared to placebo after two weeks of administration in 700 subjects with dry eye syndrome.
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Lead Product(s): Pegcetacoplan
Therapeutic Area: Ophthalmology Product Name: APL-2
Highest Development Status: Phase III Product Type: Peptide
Partner/Sponsor/Collaborator: Swedish Orphan Biovitrum AB
Deal Size: $1,245.0 million Upfront Cash: $250.0 million
Deal Type: Collaboration October 27, 2020
Details:
Under the collaboration, Sobi gets global co-development and exclusive ex-US commercialisation rights for systemic pegcetacoplan. Apellis retains US commercialisation rights for systemic pegcetacoplan and worldwide commercialisation rights for ophthalmological pegcetacoplan.
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Lead Product(s): Reproxalap
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 October 22, 2020
Details:
The new data presented at AAO this year further support the clinical utility of reproxalap, the first novel mechanistic approach in late-stage allergic conjunctivitis clinical trials in decades, as uniquely effective.
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Lead Product(s): Reproxalap
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 October 22, 2020
Details:
Compared to vehicle, reproxalap demonstrated statistically significant and clinically relevant improvements in subject-reported ocular itching and tearing and investigator-assessed ocular redness over the duration of exposure in the allergen chamber.
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Lead Product(s): Thymosin Beta-4
Therapeutic Area: Ophthalmology Product Name: RGN-259
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 October 14, 2020
Details:
ReGenTree licensed the rights to RGN-259 from RegeneRx in 2015 and has completed two phase 3 studies in the U.S. for dry eye: ARISE-1 and ARISE-2.
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Lead Product(s): Bevacizumab
Therapeutic Area: Ophthalmology Product Name: Lytenava
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 October 13, 2020
Details:
The open-label safety study is being conducted to ensure that an adequate number of safety exposures to ONS-5010 / LYTENAVA™ (bevacizumab-vikg) are available to support Outlook Therapeutics’ initial Biologics License Application (BLA) filing for wet AMD with the FDA.
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Lead Product(s): Atropine
Therapeutic Area: Ophthalmology Product Name: MicroPine
Highest Development Status: Phase III Product Type: Small molecule
Partner/Sponsor/Collaborator: Bausch Health
Deal Size: $45.0 million Upfront Cash: $10.0 million
Deal Type: Licensing Agreement October 12, 2020
Details:
Bausch Health has acquired an exclusive license in the U.S and Canada for the development and commercialization of an investigational microdose formulation of atropine ophthalmic solution, which is being investigated for the reduction of nearsightedness, in children ages 3-12.
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Lead Product(s): RGN-259
Therapeutic Area: Ophthalmology Product Name: RGN-259
Highest Development Status: Phase III Product Type: Large molecule
Partner/Sponsor/Collaborator: ReGenTree
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Financing October 12, 2020
Details:
The funding will provide working capital through the first quarter of 2021 and while we await the completion of our phase 3 dry eye clinical trial (ARISE-3) expected later this year.
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Lead Product(s): Ranibizumab
Therapeutic Area: Ophthalmology Product Name: SB11
Highest Development Status: Phase III Product Type: Large molecule
Partner/Sponsor/Collaborator: Samsung Bioepis
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 06, 2020
Details:
European Medicines Agency (EMA) has accepted for review the Marketing Authorisation Application for SB11, a proposed biosimilar referencing Lucentis® (ranibizumab).
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Lead Product(s): Atropine
Therapeutic Area: Ophthalmology Product Name: MicroPine
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 October 05, 2020
Details:
Eyenovia will provide pre-recorded updates on the CHAPERONE (evaluation of low-dose atropine for the reduction of pediatric myopia progression) and the VISION (evaluation of low-dose pilocarpine for improvement in near vision) clinical trials.
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