Privately held Orasis Pharmaceuticals Ltd. is a step closer to challenging Abbvie Inc.’s Vuity (pilocarpine hydrochloride) ophthalmic solution for treating presbyopia, a version of farsightedness. Orasis plans to submit an NDA to the U.S. FDA in the second half of the year based on phase III results from two studies showing CSF-1 hit its primary and secondary endpoints.
Aurion Biotech Inc. pulled down a $120 million financing to advance efforts with its lead candidate, a cell therapy for the treatment of corneal edema secondary to endothelial dysfunction (CESED).
Ji Xing Pharmaceuticals Ltd. has acquired greater China rights to two candidates from Lenz Therapeutics Inc. for the treatment of presbyopia in greater China in a deal worth up to $110 million. San Diego-based Lenz will receive $15 million in up-front payments, up to $95 million in regulatory and commercial milestone payments, and potential royalty payments based on net sales.
Shares in Gensight Biologics SA dropped by as much as 41% April 7 on news that the Paris-based gene therapy firm failed to complete a second manufacturing campaign within five months, a setback that could delay a commercial launch of its lead product, Lumevoq, by at least a year.
Citing a court order for its haste, the U.S. FDA skipped the draft and went straight to issuing a final guidance that will change how certain ophthalmic drugs are regulated.
Hansoh Pharmaceutical Group Co. Ltd. has won a green light for inebilizumab, approved by China’s NMPA for the treatment of adults with neuromyelitis optica spectrum disorders (NMOSD) who are anti-aquaporin-4 immunoglobulin G (AQP4-IgG) seropositive. The decision marked Hansoh’s first biologic approval.
U.K. biotech Complement Therapeutics Ltd has come out of stealth mode with €5 million ($5.7 million) in seed funding to tackle complement-related diseases, initially targeting the currently untreatable condition geographic atrophy due to dry age-related macular degeneration.
LONDON – The team that opened up the market for anti-vascular endothelial growth factor (VEGF) drugs in the treatment of eye diseases has formed a new company, Eyebio Ltd., with the aim of developing a new generation of ocular therapies. David Guyer and Anthony Adamis, founders of Eyetech Pharmaceuticals Inc., which brought Macugen (pegaptanib sodium) through to FDA approval in December 2004, set up Eyebio in August last year, with seed funding from SV Health Investors.
Kodiak Sciences Inc. shares (NASDAQ:KOD) closed at $9.86, down $40.49, or 80.42% after the firm unveiled top-line data from its randomized, double-masked, active comparator-controlled phase IIb/III trial testing KSI-301, an antibody biopolymer conjugate, in treatment-naïve subjects with wet age-related macular degeneration (AMD).
LONDON – In the largest-ever series A for a Spanish biotech, Splicebio S.L. has raised €50 million (US$56.9 million) to apply its protein splicing technology to the delivery of large genes that do not fit into existing vectors. The company claims its approach will overcome the capacity constraints of adeno-associated viral vectors (AAVs), by splitting genes into parcels and reconstituting the proteins they express in vivo.
RSS
