The FDA sent a complete response letter (CRL) to Allergan plc, an Abbvie Inc. company, and Molecular Partners AG, of Zurich, Switzerland, regarding the BLA for abicipar pegol, their VEGF-A inhibitor-Darpin therapy for patients with wet age-related macular degeneration (AMD).
PERTH, Australia – Melbourne, Australia-based Opthea Ltd. announced positive top-line results of its phase IIa trial evaluating safety and efficacy of OPT-302 administered with Eylea (aflibercept, Regeneron Pharmaceuticals Inc.) in treatment-refractory patients with persistent diabetic macula edema (DME).
LONDON – Oculis SA has delivered positive phase IIb data for OCS-01, a topical nanoparticle formulation of dexamethasone, in the treatment of the after-effects of cataract surgery, meeting the primary endpoints of reducing both inflammation and pain.
DUBLIN – Dyno Therapeutics Inc., an early stage gene therapy firm applying artificial intelligence to advanced capsid engineering, has entered partnerships with Novartis AG and Sarepta Therapeutics Inc., in ophthalmic indications and muscle diseases, respectively, which have over $2 billion in biobucks attached.
Keen to address a rare vision-limiting disorder endured by nearly 1.9 million people globally, ophthalmology specialist Santen Pharmaceutical Co. Ltd. has negotiated a $252 million ex-U.S. licensing deal for Jcyte Inc.'s Jcell, a human retinal progenitor cell therapy initially aimed at treating retinitis pigmentosa.
HONG KONG – Daiichi Sankyo Co. Ltd., Mitsubishi UFJ Capital Co. Ltd. and Nagoya Institute of Technology have kicked off research on a joint project for a gene therapy that could be applied to the restoration of vision.
New York-based Immunovant Inc.’s phase IIa results with neonatal Fc receptor (FcRn)-targeting IMVT-1401 in thyroid eye disease (TED), also known as Graves’ ophthalmopathy, prompted renewed speculation about the space, hot since the approval on Jan. 21 of Tepezza (teprotumumab-trbw) from Horizon Therapeutics plc, of Dublin.
BEIJING – Eye disease specialist Arctic Vision (Shanghai) Biotechnology Co. Ltd. has in-licensed from Clearside Biomedical Inc., an U.S. ophthalmology biotech, the commercialization and development rights of Xipere (triamcinolone acetonide suprachoroidal injectable suspension) for greater China and South Korea. Under the license agreement, Clearside will receive $4 million up front plus additional milestone payments from Arctic Vision for achieving specified events before Xipere wins approval in the U.S.
Kala Pharmaceuticals Inc. plans to use its positive phase III data in dry eye disease (DED) with KPI-121 (loteprednol etabonate ophthalmic suspension 0.25%) as the basis for the resubmission of its NDA in the second quarter of 2020.
Abpro Therapeutics Inc. has granted an exclusive license to Abpro Bio Co. Ltd., the former Ugint Co. Ltd., to develop and commercialize two bispecific antibodies in Asian markets, including greater China, Japan and South Korea.