Dry eye

Patient with dry eye disease using eye drops
#Aldeyra Therapeutics #Dry eye #FDA #Ophthalmology

FDA finds lack of evidence for dry eye disease drug approval

Aldeyra Therapeutics has received a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA) for the New Drug Application (NDA) of reproxalap, an investigational drug candidate, for the treatment of dry eye disease.   The CRL states that there is “a lack of substantial evidence… Read More

#News #Regulatory

Patient receiving eye drops
#CS Pharmaceuticals #Dry eye #Mergers and acquisitions #Ophthalmology

CS acquires AxeroVision’s dry eye disease pipeline

CS Pharmaceuticals (CSP) has acquired AxeroVision, a company developing novel therapies for the treatment of dry eye disease (DED) and other ophthalmic inflammatory diseases that address the underlying inflammatory processes. Darren Mercer, Chief Executive of CSP, said: “We are thrilled to acquire AxeroVision, and in particular… Read More

#Business & Investment #News

Patient with dry eye disease using eye drops
#Dry eye #FDA #Ophthalmology #Phase III trial #Stem cells

Stem cell dry eye therapy could offer rapid and total relief

The US Food and Drug Administration (FDA) has approved the Phase III clinical trial design for BRIM Biotechnology’s lead candidate for dry eye disease (DED), BRM421. BRIM will submit the Phase III study protocol to the FDA later this year.  BRM421 is a novel, first-in-class regenerative peptide… Read More

#News #Regulatory