Yahoo Finance Alcon (ALC) Achieves FDA 510(k) Clearance for Unity VCS and Unity CS
Alcon Inc. ALC recently received the FDA’s 510(k) clearance for its Unity Vitreoretinal Cataract System (VCS) and Unity Cataract System (CS). Both the systems will be introduced from Alcon’s Unity portfolio.
Unity VCS and Unity CS are designed to deliver transformative surgical innovation. With these proprietary technologies, the eye care major expects to hold its market-leading position in the global cataract and retina procedural packs (consumables used in each surgery) market.
About Unity VCS and Unity CS
Unity VCS console is used during anterior (i.e., phacoemulsification and removal of cataracts) and posterior segment (i.e., vitreoretinal) ophthalmic surgery. It works when paired with other compatible devices. With the optional laser, this system is recommended for photocoagulation (i.e. vitreoretinal and macular pathologies), iridotomy, and trabeculoplasty procedures.
Unity CS console, when used with compatible devices, is indicated for use during anterior segment (i.e. phacoemulsification and removal of cataracts) ophthalmic surgery.
Unity VCS and Unity CS will be supported by Alcon’s training, product maintenance, and Services teams.
More on the News
Unity VCS and Unity CS have been tested during investigational advisory wet lab sessions with more than 200 surgeons from over 30 countries.
Following the FDA clearance, the company will start a thorough program to get real-world feedback before the commercial launch of the systems in 2025. Regulatory submissions will continue later this year in markets across the globe. ALC expects to receive a CE Mark by early 2025.
The introduction of Unity VCS and Unity CS should help increase the productivity of Alcon’s CONSTELLATION Vision System for vitreoretinal procedures and CENTURION Vision System with ACTIVE SENTRY for cataract surgery.
The Alcon Vision Suite is set to expand its current product portfolio with innovative Unity products, which are expected to be introduced over the coming years.
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Industry Prospects
Per a Future Insights report, the cataract surgery device market has been valued at $8.93 billion in 2024 and is expected to reach $12.47 billion in 2034, at a CARG of 3.40% during the period. Factors influencing the market growth include increasing sales of cataract surgery devices with the increase in the number of people affected by cataracts, thus leading to cataract surgery and the development of advanced technology.
Thus, Alcon’s invention of Unity VCS and Unity CS has turned out to be in favor of the growing cataract surgery device market.
Other Recent Developments
Earlier in March, Alcon announced that AcrySof IQ Vivity and Clareon Vivity’s extended depth of focus (EDOF) intraocular lenses (IOLs) have surpassed more than 1 million implants worldwide. Vivity IOL provides an extended range of vision from distance to near, with low levels of visual disturbances.A study showed high patient satisfaction among several patient cohorts, as the vast majority of patients report that they are satisfied with their sight. Additionally, more than 91% of patients report no haloes, glares, or starbursts.
In February 2024, Alcon announced its first-of-a-kind MARLO app available for download on iOS mobile devices at the SECO International meeting in Atlanta, GE. MARLO app helps eye care professionals provide patients with trusted, personalized recommendations, including online contact lens ordering.
Price Performance
Year to date, shares of ALC have risen 14.1% compared with the industry’s 5.5% growth.
Zacks Rank and Key Picks
Alcon current carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the broader medical space are Hims & Hers Health, Inc. HIMS, The Joint Corp. JYNT, and Lantheus Holdings, Inc. LNTH. While Hims & Hers and The Joint currently sport a Zacks Rank #1 (Strong Buy) each, Lantheus carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
The Hims & Hers Heath stock has surged 169.4% in the past year. Estimates for the company’s earnings have moved north by 5.6% to 19 cents for 2024 in the past 30 days.
HIMS’ earnings beat estimates in three of the trailing four quarters and missed in one, delivering an average surprise of 79.2%. In the last reported quarter, it posted an earnings surprise of a staggering 150%.
Estimates for The Joint’s 2024 earnings per share (EPS) have moved up 61.5% to 21 cents in the past 60 days. Shares of JYNT have surged 6.5% in the past year compared with the industry’s 2.3% growth.
In the last reported quarter, JYNT delivered an earnings surprise of 300%. It has a trailing four-quarter average earnings surprise of 18.75%.
Estimates for Lantheus’ fiscal 2024 EPS have remained unchanged at $7.11 in the past 30 days. Shares of the company have risen 27.6% year to date compared with the industry’s growth of 3.9%.
LNTH’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 13.6%. In the last reported quarter, it delivered an earnings surprise of 9.03%.
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