The US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to Regeneron Pharmaceuticals for its Biologics License Application (BLA) for aflibercept 8mg to treat wet diabetic macular oedema (DME), age-related macular degeneration (wAMD) and diabetic retinopathy (DR).
The US Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to HuidaGene Therapeutics’ HG004 gene replacement therapy.
Selagine has signed a research, development and sublicense agreement with Grifols for the development and commercialisation of immunoglobulin eye drops for dry eye disease.
Exegenesis Bio has received clearance from the US Food and Drug Administration (FDA) for its investigational new drug (IND) application for gene therapy EXG102-031.
Avista Therapeutics has announced partnership with Roche to develop new AAV gene therapy vectors for the eyes.
Aurion Biotech has raised $120m from biotech and ophthalmology investors to progress its cell therapy programme for corneal edema secondary to endothelial dysfunction.
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