Ophthalmology

The US Food and Drug Administration (FDA) has designated the investigation of Endogena Therapeutics’ EA-2353 for the treatment of retinitis pigmentosa (RP) as a Fast Track development programme.   Fast Track is a process designed to enable patients to benefit earlier from important new drugs for serious conditions.   EA-2353 takes a novel, small-molecule approach and selectively […]

This is the latest episode of the free DDW podcast, “A deep dive into the future of ophthalmology”. It covers two articles written for Volume 23, Issue 1 – Winter 2021/22 of DDW. They are called “Innovation, investment and commitment: Genentech’s approach to the future of ophthalmology” and “Innovative delivery of sustained ophthalmic steroids for […]

Oregon State University College of Pharmacy scientists have shown that lipid nanoparticles and messenger RNA could treat blindness associated with a rare genetic condition.  Researchers developed nanoparticles able to penetrate the neural retina and deliver mRNA to the photoreceptor cells whose proper function makes vision possible.  The study, led by OSU Associate Professor of Pharmaceutical […]

The US Food and Drug Administration (FDA) has granted Orphan Drug Designation for iOnctura’s IOA-244, which is in development for solid and hematologic malignancies including uveal melanoma.  Uveal melanoma is a disease in which cancer originates in the tissues of the eye, causing symptoms such as blurred vision or a dark spot on the iris.   […]

Cancer Focus Fund is investing $5 million in funding to support ISA103, ISA Pharmaceuticals’ PRAME-targeting immunotherapy, in a first-in-human study for the treatment of uveal melanoma, a rare ocular cancer.  Cancer Focus Fund was established in collaboration with The University of Texas MD Anderson Cancer Center to provide funding and clinical expertise to advance promising […]

Biopharmaceutical company Rezolute has initiated a Phase II proof-of-concept study for RZ402, a plasma kallikrein inhibitor (PKI) being developed as an oral therapy for the treatment of diabetic macular oedema (DMO).   The current standard of care for DMO is anti-vascular growth factor (anti-VEGF) injections into the eye, requiring repeated administration over recurring periods of time […]

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 therapy which, if successful, could offer patients full […]

News round-up for 3-7 October by DDW Digital Content Editor Diana Spencer This week has brought new trial results and regulatory approvals shedding light and bringing hope into therapy areas of unmet need. The University of Birmingham and King’s College London have furthered our understanding of difficult to treat cancers, while Janssen has revealed encouraging results […]

Results from Phase I/II MGT009 study into investigational gene therapy botaretigene sparoparvovec suggest sustained vision improvement in patients with X-linked retinitis pigmentosa (XLRP).  The study found treatment with botaretigene sparoparvovec had an acceptable safety profile and demonstrated encouraging improvements in retinal sensitivity, visual function and functional vision.  The late-breaking results were revealed at the American […]

Clinical-stage pharmaceutical company Visus Therapeutics has signed a licensing agreement for the development and commercialisation of its pupil-modulating eye drops with Zhaoke Ophthalmology.  Under the terms of the agreement, Zhaoke will be responsible for clinical development, regulatory approval and commercialisation of Visus’ Brimochol PF and Carbachol PF in Greater China, South Korea and select Southeast […]

Evotec has entered a target and drug discovery partnership with Boehringer Ingelheim, focusing on induced pluripotent stem cell (iPSC)-based disease modelling for ophthalmologic disorders.   Context   Millions of people are affected by vision-related diseases worldwide, and there is a high unmet need for novel therapeutic solutions.   The partnership  Through phenotypic screening of human iPSC-derived cells, supported […]