Drugs in Dev. Ophthalmology
Phase III
Germany 
Lead Product(s) : Aflibercept
Therapeutic Area : Ophthalmology
Study Phase : Phase III
Sponsor : Regeneron Pharmaceuticals
Deal Size : Inapplicable
Deal Type : Inapplicable
Eylea 8mg Confirmed Safe and Effective for DME Over Three Years of Dosing
Details : Eylea HD (aflibercept) is a PGF & VEGF-A inhibitor, its 8 mg formulation is being evaluated as an extended dosing intervals for the treatment of diabetic macular edema (DME).
Product Name : Eylea
Product Type : Cell and Gene therapy
Upfront Cash : Inapplicable
October 19, 2024
Lead Product(s) : Aflibercept
Therapeutic Area : Ophthalmology
Highest Development Status : Phase III
Sponsor : Regeneron Pharmaceuticals
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Aflibercept
Therapeutic Area : Ophthalmology
Study Phase : Phase III
Sponsor : MS Pharma
Deal Size : Undisclosed
Deal Type : Licensing Agreement
MS Pharma Partners for FYB203 Biosimilar Commercialization in MENA Region
Details : MS Pharma becomes a partner for the commercialization of FYB203, Formycon’s Biosimilar to Eylea® (Aflibercept), in the MENA Region for the treatment of neovascular age-related macular degeneration.
Product Name : FYB203
Product Type : Cell and Gene therapy
Upfront Cash : Undisclosed
May 14, 2024
Lead Product(s) : Aflibercept
Therapeutic Area : Ophthalmology
Highest Development Status : Phase III
Sponsor : MS Pharma
Deal Size : Undisclosed
Deal Type : Licensing Agreement
Lead Product(s) : Aflibercept
Therapeutic Area : Ophthalmology
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Bayer’s Aflibercept 8 mg Recommended for Approval in EU
Details : Eylea (aflibercept) is a PGF & VEGF-A inhibitor, its 8 mg formulation is being evaluated in PULSAR clinical trial for the treatment of neovascular (wet) age-related macular degeneration (nAMD) and in PHOTON trial in diabetic macular edema (DME).
Product Name : Eylea
Product Type : Cell and Gene therapy
Upfront Cash : Inapplicable
October 11, 2023
Lead Product(s) : Aflibercept
Therapeutic Area : Ophthalmology
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Aflibercept
Therapeutic Area : Ophthalmology
Study Phase : Phase III
Sponsor : Coherus Biosciences
Deal Size : Undisclosed
Deal Type : Acquisition
Details : FYB203, a biosimilar candidate to Eylea (aflibercept), which Klinge Biopharma has in-licensed from the German biosimilar developer Formycon AG, is being evaluated in a Phase 3 clinical trial in patients with Neovascular (wet) Age-Related Macular Degenera...
Product Name : FYB203
Product Type : Cell and Gene therapy
Upfront Cash : $32.5 million
September 01, 2023
Lead Product(s) : Aflibercept
Therapeutic Area : Ophthalmology
Highest Development Status : Phase III
Sponsor : Coherus Biosciences
Deal Size : Undisclosed
Deal Type : Acquisition
Lead Product(s) : Cyclosporine
Therapeutic Area : Ophthalmology
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : CyclASol® consists of cyclosporine solubilized in a novel water-free excipient, perfluorobutylpentane , it is specifically developed as a potent and comfortable anti-inflammatory dry eye drug therapy with rapid onset of effect for dry eye patients.
Product Name : CyclASol
Product Type : Peptide
Upfront Cash : Inapplicable
August 02, 2023
Lead Product(s) : Cyclosporine
Therapeutic Area : Ophthalmology
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Cyclosporine
Therapeutic Area : Ophthalmology
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : CyclASol® (cyclosporine ophthalmic solution), a first-of-its-kind anti-inflammatory product for the treatment for the signs and symptoms of dry eye disease (DED).
Product Name : CyclASol
Product Type : Peptide
Upfront Cash : Inapplicable
October 24, 2022
Lead Product(s) : Cyclosporine
Therapeutic Area : Ophthalmology
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Ranibizumab
Therapeutic Area : Ophthalmology
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
EMA CHMP Recommends Grant of Marketing Authorization of Ranibizumab Biosimilar
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.
Product Name : Ranivisio
Product Type : Antibody
Upfront Cash : Inapplicable
June 23, 2022
Lead Product(s) : Ranibizumab
Therapeutic Area : Ophthalmology
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Aflibercept
Therapeutic Area : Ophthalmology
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Phase III PULSAR trial in nAMD and phase II/III PHOTON trial in DME respectively met primary endpoint of non-inferiority of Eylea (aflibercept) 8 mg extended dosing regimens for best visual acuity at week 48, compared to Eylea dosed every 8 weeks.
Product Name : Eylea
Product Type : Cell and Gene therapy
Upfront Cash : Inapplicable
May 11, 2022
Lead Product(s) : Aflibercept
Therapeutic Area : Ophthalmology
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Perfluorohexyloctane
Therapeutic Area : Ophthalmology
Study Phase : Phase III
Sponsor : Bausch Health
Deal Size : Inapplicable
Deal Type : Inapplicable
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.
Product Name : NOV03
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
April 25, 2022
Lead Product(s) : Perfluorohexyloctane
Therapeutic Area : Ophthalmology
Highest Development Status : Phase III
Sponsor : Bausch Health
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Perfluorohexyloctane
Therapeutic Area : Ophthalmology
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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 fl...
Product Name : NOV03
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
December 16, 2021
Lead Product(s) : Perfluorohexyloctane
Therapeutic Area : Ophthalmology
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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