VUITY Receives FDA Approval as First Drop to Treat Presbyopia

• At press time, Allergan announced the FDA approval of VUITY (pilocarpine HCl ophthalmic solution) 1.25% for the treatment of presbyopia, commonly known as age-related blurry near vision, in adults. VUITY is the first and only FDA-approved eye drop to treat this common and progressive eye condition that affects 128 million Americans.

The daily prescription eye drop works in as early as 15 minutes and lasts up to 6 hours, as measured on day 30, to improve near and intermediate vision without impacting distance vision, according to Allergan. Specifically designed for presbyopia, VUITY is an optimized formulation of pilocarpine, delivered with pHast technology.

The approval of VUITY is based on data from two pivotal phase 3 clinical studies, GEMINI 1 and GEMINI 2, which evaluated the efficacy, safety and tolerability of VUITY for the treatment of presbyopia. In both studies, VUITY met the primary endpoint, reaching statistical significance in improvement in near vision in low light (mesopic) conditions without a loss of distance vision, versus the vehicle (placebo) on day 30 at hour 3. No serious adverse events were observed in either study.

In other news, Allergan launched BlurryNearVision.com , an interactive website offering presbyopia information.

B+L Announces Positive Outcomes for Premium LuxSmart IOLs

• Bausch + Lomb has announced positive outcomes following the one-year real-world evaluation of its premium LuxSmart lens, since its European launch in 2020. LuxSmart is designed to provide continuous vision from distance to intermediate, and has been adopted by 200 surgeons across 18 countries. It is not yet available in the United States. More than 5,000 cataract patients have now been treated worldwide, including more than 4,000 across Europe. B+L says LuxSmart is suitable for use in patients with some co-morbidities and could be used to achieve near vision through micromonovision (with the difference between the two eyes being less than 0.75D). It is a hydrophobic lens, designed with Pure Refractive Optics (PRO) technology.

Evaluation in bilateral cataract patients indicates that LuxSmart performs extremely well at distance (BCDVA, -0.03 logMAR) and intermediate (DCIVA at 80 and 66 cm, mean 0.07 and 0.14 logMAR, respectively). DCNVA at 40 cm reached 0.38 logMAR, when treating bilateral cataract.

M&S Technologies Introduces DVA-5000 for Clinical Trial ETDRS and Contrast Sensitivity Function Testing

• M&S Technologies has introduced the DVA-5000 for Clinical Trial ETDRS and contrast sensitivity function testing, part of the company’s Clinical Trial Suite (CTS). The company says the automated-testing protocols used in the DVA-5000 are significantly more efficient and accurate than traditional testing methods. CTS test results are automatically calculated and ready for review as letter score, logMAR, decimal score, and Snellen equivalent. Secure and trusted reports are immediately available in XML or CSV format for export to any EDC, Reading Center, or other location of choice.

M&S says it’s important to note that the FDA recognizes CTS testing modules as an acceptable method of testing in all phases of clinical trials, including PMA trials. Over the past several years, CTS has been used in more than 140 clinical trials, including 40 active trials. All CTS modules, including the DVA-5000, provide accurate, consistent, and repeatable paperless test results from site-to-site and visit-to-visit.

Orasis Appoints Julie Speed as Senior VP, Head of Strategy and Marketing

• Orasis Pharmaceuticals has appointed Julie Speed as senior vice president (SVP), head of strategy and marketing. Ms. Speed has two decades of leadership experience in eye care and will be responsible for developing brand strategy and building the marketing organization as Orasis prepares for Phase 3 readout and FDA submission for the company's lead candidate for the treatment of presbyopia, CSF-1.

Ms. Speed’s experience covers both pharmaceuticals and medical devices. Her expertise spans from commercial leadership positions at Alcon and Johnson & Johnson Surgical Vision, advancing commercial strategy and brands, to start-up organizations Eyevance and TearLab, building marketing strategy and teams from the ground up. She also has broad marketing and launch experience with U.S. and global brands.

Visus Therapeutics Hosts Inaugural Capital Markets Day in New York City

• Visus Therapeutics recently welcomed investors, analysts, and media to its inaugural Capital Markets Day in New York City. Visus’ management team and leading eye care experts presented new information on the company’s lead asset, BRIMOCHOL, an investigational eye drop for the treatment of presbyopia. The executives and experts discussed therapeutic utility and commercial potential for BRIMOCHOL, as well as results of a recent market research survey. The company also discussed its ophthalmic drug candidates and introduced a novel drug delivery platform licensed from DelSiTech that has the potential to help optimize the clinical benefit of ophthalmic therapies.

Research results that were presented include: an estimate that the addressable population for presbyopia-correcting drops in the U.S. is between 70-90 million; the main drivers for market uptake and adoption for presbyopia-correcting eye drops will be efficacy and treatment duration, with most ECPs preferring a drop that lasts at least eight hours; and that approximately half of the ECPs highlighted the value of a preservative-free eye drop option for patients with dry eye disease. ■