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Ophthalmic Business News
Early positive data reported for geographic atrophy modifier gene therapy
OCU410, a single-dose modifier gene therapy, demonstrated positive preliminary outcomes for the treatment of geographic atrophy in a phase 1/2 clinical trial, according to a press release from Ocugen.
FDA grants rare pediatric disease, fast track designations to Stargardt disease therapy
The FDA granted rare pediatric disease and fast track designations to gildeuretinol, an investigational oral therapy for the treatment of Stargardt disease, according to a press release from Alkeus Pharmaceuticals.
European Commission approves Opuviz as aflibercept biosimilar
The European Commission has approved Opuviz 40 mg/mL solution, a biosimilar referencing Eylea, according to a press release from Samsung Bioepis and Biogen.
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Adverum reports positive 52-week, 4-year data for wet AMD gene therapy
Adverum Biotechnologies reported positive 52-week data from the phase 2 LUNA trial as well as long-term follow-up results from the OPTIC trial of Ixo-vec in patients with wet age-related macular degeneration.
Aldeyra receives PDUFA date for reproxalap, expands AbbVie option agreement
The FDA has accepted the resubmitted new drug application for reproxalap, an investigational treatment for dry eye disease, and assigned a Prescription Drug User Fee Act date, according to a press release from Aldeyra Therapeutics.
Diversified portfolios allow for ‘smoother ride’
Why not just invest in one stock and let it ride? That works well if you bet the farm on Apple in 2010 and watched your fortune explode 30 time during the last 14 years.
AlloVir to merge with Kalaris Therapeutics
AlloVir, an allogeneic T cell immunotherapy company, will merge with Kalaris Therapeutics to focus on retinal diseases, according to a press release.
VIDEO: Ocular Therapeutix shifts to retina-focused treatments
CHICAGO — In this Healio Video Perspective from Eyecelerator@AAO, Peter K. Kaiser, MD, of Ocular Therapeutix, discusses the company’s shift to a retina-focused program.
FDA extends Prescription Drug User Fee Act date for macular telangiectasia type 2 therapy
The FDA has extended its Prescription Drug User Fee Act date for the biologics license application for NT-501, a treatment for macular telangiectasia type 2, according to a press release from Neurotech Pharmaceuticals.
FDA grants de novo authorization to photobiomodulation device for dry AMD
The FDA granted de novo marketing authorization Valeda Light Delivery System for the treatment of dry age-related macular degeneration, according to a press release from LumiThera.
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