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November 11, 2024
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WikiGuidelines group publishes first new UTI guidance in 14 years

Ophthalmic Business News

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November 21, 2024
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Early positive data reported for geographic atrophy modifier gene therapy

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.

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November 20, 2024
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FDA grants rare pediatric disease, fast track designations to Stargardt disease therapy

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.

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November 19, 2024
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European Commission approves Opuviz as aflibercept biosimilar

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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UTI
November 11, 2024
3 min read
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WikiGuidelines group publishes first new UTI guidance in 14 years

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November 19, 2024
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Adverum reports positive 52-week, 4-year data for wet AMD gene therapy

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.

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November 18, 2024
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Aldeyra receives PDUFA date for reproxalap, expands AbbVie option agreement

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.

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November 14, 2024
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Diversified portfolios allow for ‘smoother ride’

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.

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November 11, 2024
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AlloVir to merge with Kalaris Therapeutics

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.

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November 11, 2024
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VIDEO: Ocular Therapeutix shifts to retina-focused treatments

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.

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November 08, 2024
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FDA extends Prescription Drug User Fee Act date for macular telangiectasia type 2 therapy

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.

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November 05, 2024
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FDA grants de novo authorization to photobiomodulation device for dry AMD

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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