Strongly favorable six-month data disclosed on Jan. 9 by Applied Genetic Technologies Corp. (AGTC) from its ongoing phase I/II program with an adeno-associated virus (AAV) gene therapy for X-linked retinitis pigmentosa (XLRP) did more than provide a whopping stock boost.
LONDON – Oculis SA reported positive results for its topical nanoparticle formulation of dexamethasone in the treatment of diabetic macular edema (DME), showing the eye drops reduced central macular thickness (CMT) in the phase II proof-of-concept trial.
Lineage Cell Therapeutics Inc. CEO Brian Culley told BioWorld that concerns about the pace of the company’s dry age-related macular degeneration (AMD) phase I/IIa trial have been alleviated after an independent data safety monitoring board (DSMB) decreed that the study’s protocol-mandated treatment stagger can be removed.
An international collaborative study led by geneticists at the Queensland Institute of Medical Research Berghofer Medical Research Institute (QIMR) in Brisbane, Australia, has used a multivariate approach to develop a polygenic risk score (PRS) for glaucoma.
HONG KONG – Bionetix Inc., of Suwon, South Korea, has secured ₩10.8 billion (US$9.33 million) in series B funding. The biotech, founded in February 2017, has attracted a total of KRW14.7 billion to date. The company will use the funds to advance NTX-301, a therapy for myelodysplastic syndrome/acute myeloid leukemia (MDS/AML) with epigenetic dysregulation, and NTX-101, a glaucoma treatment.
With a newly raised $60 million series B financing, Tarsus Pharmaceuticals Inc. plans to start a phase IIb/III trial of its lead product, TP-03, for treating demodex blepharitis, and to jumpstart two other clinical programs.
Unveiled by Oxfordshire, U.K.-based Immunocore Ltd. at the November meeting of the Society for Immunotherapy of Cancer (SITC) in National Harbor, Md., were encouraging new findings from the phase I/II study with tebentafusp (also known as IMC-gp100), a bispecific protein in the pivotal works for metastatic uveal melanoma (MUM). The results showed a correlation between treatment-induced immune response and improvement in overall survival (OS) and tumor shrinkage in advanced uveal as well as cutaneous melanoma.
As expected, Horizon Pharma plc sailed through the meeting of the FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee regarding the BLA for teprotumumab in thyroid eye disease (TED) with few surprises but much discussion.
Hitches for Horizon Pharma plc seem unlikely in the upcoming FDA advisory panel to mull the BLA for teprotumumab in thyroid eye disease (TED), though regulators did take issue with the clinical activity score (CAS) as calculated by the company.
PERTH, Australia – On the heels of positive phase IIb data, Melbourne-based Opthea Ltd. announced a private placement of AU$50 million (US$33.87 million) from institutional investors in Australia and the U.K. to advance lead candidate OPT-302 to phase III trials in wet age-related macular degeneration (AMD).