Ophthalmology

Harrow buys US and Canadian commercial rights for Santen’s Ophthalmic products

US eyecare pharmaceutical company Harrow has signed agreements with affiliates of Santen Pharmaceutical to acquire certain US and Canadian commercial rights for some of the branded ophthalmic products from the latter.

Regeneron receives FDA response letter for aflibercept’s BLA

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).

FDA grants orphan drug designation to HuidaGene gene therapy for blindness

The US Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to HuidaGene Therapeutics’ HG004 gene replacement therapy.

Selagine, Grifols agree to develop, commercialise immunoglobulin eye drops

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 receives US FDA clearance for EXG102-031 IND application

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, Roche partner to develop AAV gene therapy vectors for eyes

Avista Therapeutics has announced partnership with Roche to develop new AAV gene therapy vectors for the eyes.

Aurion Biotech raises $120m to advance cell therapy programme

 Aurion Biotech  has raised $120m from biotech and ophthalmology investors to progress its cell therapy programme for corneal edema secondary to endothelial dysfunction.