Week in Review - January 7, 2024

Hello, I am David Hutton of Ophthalmology Times.Welcome to a special edition of the Ophthalmology Times EyePod Week in Review Podcast, offering some of the week’s top headlines. Let’s get started.

FDA approves the VISUMAX 800 with SMILE pro software for surgically treating nearsightedness

Zeiss Medical Technology announced the US Food and Drug Administration (FDA) has approved the VISUMAX 800 with SMILE pro software surgically treating nearsightedness, with or without astigmatism.

The VISUMAX 800 is the latest generation of Zeiss femtosecond lasers, and offers a reduced laser time when compared to its predecessors.

According to press release from Zeiss,with the VISUMAX 800 with SMILE pro software surgeons can “utilize a number of workflow enhancements including the CentraLign centration aid, a computer-controlled function for easy centration; the OcuLign cyclotorsion adjustment to help counter cyclotorsion that may occur; and VISULYZE user nomograms to help surgeons collect and analyze patient data, while also providing detailed nomograms and enabling more control during every surgery

Alcon’s dry eye candidate achieves positive topline results in Phase 3 trials

Alcon this week announced positive topline results from the two pivotal Phase 3 clinical trials (COMET-2 and COMET-3 ) evaluating the safety and efficacy of AR-15512, a candidate treatment for the signs and symptoms of dry eye disease (DED).

According to a company news release,1 in both COMET-2 (NCT05285644) and COMET-3 (NCT05360966), which enrolled more than 930 dry eye subjects in total (randomized 1:1 to AR-15512 or vehicle control), the primary endpoint of the proportion of subjects with at least a 10-mm increase in unanesthetized Schirmer’s score achieved statistical significance at Day 14 [p<0.0001]. These data are consistent with the proposed mechanism of action of AR-15512.

With the positive data, Alcon said in its news release it plans to file a New Drug Application (NDA) for AR-15512 with the FDA in mid-2024.

AR-15512 is a transient receptor potential melastatin 8 (TRPM8) agonist. TRPM8 is a cold-sensing receptor located in the cornea and eyelid and can potentially relieve symptoms of dry eye disease. The drug candidate was brought into Alcon’s portfolio following the $930 million acquisition of Aerie Pharmaceuticals in late 2022.

Harrow’s dry eye treatment hits the market

Harrow announced that cyclosporine ophthalmic solution 0.1%, a patented, non‑preserved, twice-daily (BID) dosed prescription drug based on a “water‑free” semifluorinated alkane eyedrop technology, is now available in the United States.

According to a news release from the company, the solution also is backed by a 10% money-back guarantee program.

Cyclosporine ophthalmic solution 0.1% is dispensed in a 10 microliter drop, and is the first and only cyclosporine‑based product indicated for treating both the signs and symptoms of dry eye disease.

In the news release, Harrow Chairman and CEO Mark L Baum noted the company is pleased to announce the availability of cyclosporine ophthalmic solution 0.1% for its customers and their patients.

New research aims to develop novel therapeutic for glaucoma

A team of researchers at Indiana University School of Medicine are using a novel approach to hopefully develop a new therapy for glaucoma, funded by a 5-year, $2 million R01 grant from the National Eye Institute.

According to an Indiana University School of Medicine news release, citing the Centers for Disease Control and Vision Health Initiatives, more than 3 million people in the United States have glaucoma. By 2050, that number is expected to rise to 6.3 million. Glaucoma costs the U.S. economy about $2.86 billion each year in direct costs and productivity losses.

The university noted the project, called “Therapeutic Intervention to Target Human Glaucoma Pathogenesis,” will focus on providing a foundation for developing a new glaucoma therapeutic by testing human neurons and a regenerative therapy to rescue visual neurons from dying preclinically in human eyes under glaucoma conditions.

Thank you for joining me for this special edition of the EyePod Week in Review podcast. for more details on these and other articles on the latest news and cutting-edge advancements in ophthalmology, visit our website at Ophthalmologytimes.com.