The Japan Pharmaceutical and Medical Devices Agency (PMDA) has approved Luxturna for the treatment of inherited retinal dystrophies (IRDs) caused by biallelic RPE65 mutations – Novartis

The Japan Pharmaceutical and Medical Devices Agency (PMDA) has approved Novartis’ Luxturna (voretigene neparvovec) for the treatment of inherited retinal dystrophies (IRDs) caused by biallelic RPE65 mutations. The company expects the gene therapy to be used in approximately 15 patients in Japan over five yearsIn the U.S., Luxturna was launched with a list price of $850,000, so Japan is anticipating […]

Novartis divests “front of eye” ophthalmology assets to Bausch + Lomb

Novartis announced that it has signed an agreement to divest ‘front of eye’ ophthalmology assets to Bausch + Lomb, a global eye health company, in a transaction valued up to $2.5 billion, including $1.75 billion in upfront cash, plus additional milestone payments. The deal includes Xiidra, the first approved prescription treatment for the signs and symptoms of dry eye disease, […]

FDA approval of Rystiggo for the treatment of adults with generalized myasthenia gravis – UCB

UCB announced Rystiggo (rozanolixizumab-noli) has been approved by the FDA for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AchR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive. Rozanolixizumab-noli injection for subcutaneous infusion is a humanized IgG4 monoclonal antibody that binds to the neonatal Fc receptor (FcRN), resulting in the reduction of circulating IgG..It is […]

Additional data from phase IV Tepezza clinical trial presented at the Endocrine Society annual meeting reinforces efficacy in people with thyroid eye disease (TED) regardless of disease activity or duration – Horizon Therapeutics / Amgen

Horizon Therapeutics plc announced the presentation of new data from the randomized, double-masked, placebo-controlled Phase IV clinical trial (NCT04583735) evaluating Tepezza in patients with long disease duration and low Clinical Activity Score (CAS), a measure of disease activity. The oral presentation at the Endocrine Society Annual Meeting (ENDO 2023) supports the efficacy and safety of Tepezza in TED patients regardless […]

Cataract surgery reimbursements may not be enough for some patients

Research suggests that Medicare reimbursements for complex cataract surgery cover less than two minutes of operating time, and an increase to reimbursements for the procedure may be justified. Complex cataract surgery requires more time and resources than simple cataract surgery, and this study indicates that the incremental reimbursement for the complex surgery is not enough to offset the increased costs. “After […]

Novel imaging approach reveals important details about rare eye disease choroideremia

By combining traditional eye imaging techniques with adaptive optics – a technology that enhances imaging resolution – researchers at the National Eye Institute (NEI) have shown for the first time how cells across different tissue layers in the eye are affected in people with choroideremia, a rare genetic disorder that leads to blindness. Their study, which was funded by the […]

New diagnostic option for rare eye disease

An estimated five to ten percent of blindness worldwide is caused by the rare inflammatory eye disease uveitis. Posterior uveitis in particular is often associated with severe disease progression and the need for immunosuppressive therapy. In posterior uveitis, inflammation occurs in the retina and in the underlying choroid that supplies it with nutrients. Researchers at the Ophthalmology Department at the […]

“Step therapy” effective for diabetic macular edema

Researchers report that a therapeutic “step strategy,” in which patients with diabetic macular edema begin their treatment with a less expensive drug and, if vision fails to improve, switch to a more expensive medicine, produces similar results to beginning with the more expensive drug. The findings were published on July 14, 2022 in the NEJM/New England Journal of Medicine. “Our […]