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Details:
MIEBO (perfluorohexyloctane ophthalmic solution) is used for the treatment of the signs and symptoms of dry eye disease (DED). MIEBO is the first and only prescription eye drop approved for DED that directly targets tear evaporation.
Lead Product(s): Perfluorohexyloctane
Therapeutic Area: Ophthalmology Product Name: Miebo
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 12, 2023
Details:
Under the agreement, Senju acquires Japan rights to develop, manufacture, and commercialize NOV03 (perfluorohexyloctane ophthalmic solution), the first and only prescription treatment for signs and symptoms of dry eye disease that directly targets tear evaporation.
Lead Product(s): Perfluorohexyloctane
Therapeutic Area: Ophthalmology Product Name: NOV'03
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: SENJU PHARMACEUTICAL CO LTD
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement June 13, 2023
Details:
Miebo (perfluorohexyloctane) is the first drug approved by USFDA to treat dry eye disease associated with Meibomian gland dysfunction. It stabilizes the lipid layer for hours to protect the tear film and has the ability to penetrate the Meibomian glands.
Lead Product(s): Perfluorohexyloctane
Therapeutic Area: Ophthalmology Product Name: Miebo
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Novaliq
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 18, 2023
Details:
NOV03 (Perfluorohexyloctane) is the first drug developed to treat dry eye disease associated with Meibomian gland dysfunction in a highly effective way. It stabilizes the lipid layer for hours to protect the tear film and has the ability to penetrate the Meibomian glands.
Lead Product(s): Perfluorohexyloctane
Therapeutic Area: Ophthalmology Product Name: 37926
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Novaliq
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 04, 2023
Details:
NOV03 (perfluorohexyloctane) A potential first-in-class eye drop with a novel mechanism of action, NOV03 is an investigational therapy to treat the signs and symptoms of dry eye disease (DED) associated with Meibomian gland dysfunction (MGD).
Lead Product(s): Perfluorohexyloctane
Therapeutic Area: Ophthalmology Product Name: 37926
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Novaliq
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 06, 2022
Details:
NOV03 (perfluorohexyloctane) Ophthalmic Soluton, is an investigational, proprietary, water-free, single-component preservative-free eye drop , an investigational treatment with a proposed indication of treating the signs and symptoms of dry eye disease.
Lead Product(s): Perfluorohexyloctane
Therapeutic Area: Ophthalmology Product Name: 37926
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Novaliq
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 07, 2022
Details:
NOV03 (perfluorohexyloctane) is being investigated as a first-in-class treatment with a novel mechanism of action to treat the signs and symptoms of dry eye disease (DED) associated with Meibomian gland dysfunction (MGD).
Lead Product(s): Perfluorohexyloctane
Therapeutic Area: Ophthalmology Product Name: 37926
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 03, 2022
Details:
Presentations include results from Phase 3 trials of investigational NOV03 (perfluorohexyloctane), as well as from several studies involving products from company's consumer health care, pharmaceutical and surgical portfolios, such as XIPERE for suprachoroidal use.
Lead Product(s): Perfluorohexyloctane
Therapeutic Area: Ophthalmology Product Name: NOV03
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 28, 2022
Details:
The data show that NOV03, (perfluorohexyloctane) met both primary endpoints of total Corneal Fluorescein Staining, a measure that assesses damage to the eye, and visual analogue scale dryness score at day 57.
Lead Product(s): Perfluorohexyloctane
Therapeutic Area: Ophthalmology Product Name: NOV03
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Bausch & Lomb Incorporated
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 25, 2022
Details:
Company provided update on phase 3 trial of SHR8058 eye drops (perfluorohexyloctane) for the treatment of dry eye disease associated with Meibomian gland dysfunction and the trial met its prespecified primary sign endpoint improvement of total corneal fluorescein staining.
Lead Product(s): Perfluorohexyloctane
Therapeutic Area: Ophthalmology Product Name: SHR8058
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 16, 2021
Details:
The Phase 3 program for NOV03 also includes a previous Phase 3, multi-center, randomized, double-masked, saline-controlled trial (GOBI), for which the companies announced statistically significant topline results in April 2021.
Lead Product(s): Perfluorohexyloctane
Therapeutic Area: Ophthalmology Product Name: NOV03
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 07, 2021
Details:
First of two Phase 3 studies evaluating NOV03 as an investigational drug with a novel mechanism of action to treat the signs and symptoms of Dry eye disease associated with Meibomian gland dysfunction has been completely enrolled with a total of 599 participants.
Lead Product(s): Perfluorohexyloctane
Therapeutic Area: Ophthalmology Product Name: NOV03'
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Novaliq
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 19, 2021
Details:
NOV03 is an investigational, proprietary, water-free and preservative-free solution, based on patented EyeSol® technology from Novaliq GmbH1. DED is a chronic and serious disease of the ocular surface.
Lead Product(s): Perfluorohexyloctane
Therapeutic Area: Ophthalmology Product Name: 44138
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 24, 2020
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