[{"orgOrder":0,"company":"Formycon","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Formycon Announce current Status of BLA Review of FYB201","therapeuticArea":"Ophthalmology","highestDevelopmentStatus":"Phase III","country":"GERMANY","productType":"Large molecule","productStatus":"Biosimilar","date":"February 2020","url1":"","url2":"","graph1":"Large molecule","graph2":"Formycon"},{"orgOrder":0,"company":"STADA Arzneimittel","sponsor":"Bausch & Lomb Incorporated","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Bausch + Lomb Licenses Exclusive Rights from STADA and Xbrane to a Biosimilar Candidate for Lucentis in the United States and Canada","therapeuticArea":"Ophthalmology","highestDevelopmentStatus":"Phase III","country":"GERMANY","productType":"Large molecule","productStatus":"Biosimilar","date":"May 2020","url1":"","url2":"","graph1":"Large 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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.
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.
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 Degeneration (nAMD).
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.
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).
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.
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.
Aflibercept showed a positive benefit-risk profile in patients with ROP treated in 27 countries worldwide in the FIREFLEYE study, the first randomized prospective clinical trial comparing aflibercept to laser in premature babies with ROP requiring treatment.
CyclASol® is a topical, anti-inflammatory and immunomodulating ophthalmic solution, containing 0.1% cyclosporine A in EyeSol®, developed for the treatment of DED.
Formycon continues to work with license partner Bioeq AG and its manufacturing partner on the resubmission of the Biologics License Application (BLA) for the FYB201 project, a biosimilar candidate for Lucentis(R)* (Ranibizumab), despite the situation regarding COVID-19.