Treatment for Demodex blepharitis

Tarsus Pharmaceuticals, Inc. announced the FDA approval of Xdemvy (lotilaner ophthalmic solution) 0.25% to treat Demodex blepharitis by targeting and eradicating the root cause of the disease – Demodex mite infestation. The FDA approval of the eye drop (formerly known as TP-03) is based on results from the Saturn-1 and Saturn-2 studies, which showed a significant improvement in eyelids (reduction of collarettes, the pathognomonic sign of the disease, to no more than 2 collarettes per upper lid) by Day 43, with some patients seeing improvement as early as 2 weeks.

Tarsus       tarsusrx.com

Allografts to treat ocular surface disease

Celularity Inc. and Verséa Ophthalmics, LLC announced that the companies have entered into an exclusive U.S. commercialization agreement in which Verséa Ophthalmics will distribute Celularity’s Biovance and Biovance 3L Ocular, which are intended for use as a biological membrane covering that provides an extracellular matrix. Biovance is a single-layer allograft. Biovance 3L Ocular is acellular and consists of three layers of an amniotic membrane that supports the treatment of advanced ocular surface disease.

Verséa Ophthalmics, LLC       versea.com/divisions/ophthalmics/

Lens for day and night driving

Shamir Insight announced the availability of the Driver Intelligence spectacle lens. The lens optimizes visual performance and is designed to deliver clarity for drivers any time of the day, enabling safer driving, the company says. It is available in a package of two lens models: “Sun” for daytime and “Moon” for low-light/nighttime driving. The visual improvements for both lenses include increased road awareness, lower cognitive load for improved visual processing, and optimal physical comfort.

Shamir       shamir.com/us/shamir-driver-intelligence/

GA treatment approved

Iveric Bio received FDA approval of Izervay (avacincaptad pegol intravitreal solution) for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration. This new complement C5 inhibitor showed a statistically significant reduction (p<0.01) in the rate of GA progression at the 12-month primary endpoint across the GATHER1 and GATHER2 Phase 3 clinical trials.

Iveric       Izervay.com

PRODUCT NOTES

• EssilorLuxottica announced a consumer advertising campaign to support the launch of the company’s latest generation of Varilux progressive lens — the Varilux XR series, an eye-responsive lens powered by behavioral artificial intelligence (AI). Using AI technology, the company can establish a visual behavior profile for each individual prescription and provide an eye-responsive lens that respects the eye’s natural behavior.
• Verséa Ophthalmics announced commencement of initial shipments of its T-POC TOTAL IgE Immunoassay Kit, a quantitative point-of-care test used in the diagnosis and management of patients suffering from ocular surface disease. The company also announced it will follow with a phase 2 of the testing platform, T-POC Lactoferrin, a test for aqueous deficient dry eye disease, which can be performed on the same digital reader platform.