FDA Approves Expanded Age Indication for Staar Surgical's EVO ICL
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 15 hours ago
0mins
Source: Benzinga
- Expanded Age Indication: The FDA has approved Staar Surgical's EVO ICL for patients aged 21 to 60, expanding the potential market by nearly 8 million refractive patients, significantly enhancing growth opportunities.
- Clinical Trial Safety: The three-year follow-up of 629 eyes in the FDA clinical trial demonstrated a strong safety profile with a safety index of 1.25, no reported cases of pupillary block or pigment dispersion, and a low anterior subcapsular cataract incidence of 0.16%.
- Shifting Market Trends: The EVO ICL has become the leading procedure for patients with -8.0 diopters and above, with over half of U.S. vision correction consumers now interested in alternatives to LASIK, indicating a shift towards lens-based solutions.
- Stock Performance Analysis: Despite a 2.28% premarket increase to $16.57 following the FDA approval, the stock remains below its 20-day and 100-day simple moving averages, indicating a bearish trend, with key support at $14.50 to monitor closely.
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Analyst Views on STAA
Wall Street analysts forecast STAA stock price to rise
3 Analyst Rating
0 Buy
3 Hold
0 Sell
Hold
Current: 16.200
Low
30.75
Averages
30.75
High
30.75
Current: 16.200
Low
30.75
Averages
30.75
High
30.75
About STAA
STAAR Surgical Company designs, develops, manufactures, and sells implantable lenses for the eye and accessory delivery systems used to deliver the lenses into the eye. The Company markets and sells its ICLs for refractive surgery to treat myopia (nearsightedness) as its EVO family of lenses. Its EVO family of lenses includes its EVO ICL, EVO+ ICL, and EVO Visian ICL. The Company's newest offering, EVO Viva, has an extended depth of focus (EDoF) optic, which is designed to treat myopia with presbyopia (age-related loss of ability to focus). It also market and sell an ICL lens to treat hyperopia (farsightedness), called Visian ICL. It makes its ICL product offerings available in multiple models, powers and lengths, including some with toric ICL (TICL) versions to correct for astigmatism (blurred vision). The Company’s principal products are ICLs used in refractive surgery, including its EVO family of lenses.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
FDA Expands EVO ICL Age Indication to 60 Years
- Market Expansion: The FDA's approval to extend the age range for EVO ICL to 21-60 years opens access to nearly 8 million additional refractive patients, significantly enlarging STAAR Surgical's potential customer base in the U.S. market.
- Shift in Surgical Preference: As demand for laser refractive surgeries declines by nearly 40%, EVO ICL implantations continue to grow, with over 53% of patients expressing interest in alternatives to LASIK, indicating a meaningful shift in patient preferences for vision correction methods.
- Leading Treatment for High Myopia: EVO ICL has become the most performed refractive procedure for patients with -8.0 diopters and above, capturing 72% of the market share, demonstrating that this technology is reshaping the treatment paradigm for high myopia to meet increasing demand.
- Long-Term Safety Validation: FDA clinical trials indicate a safety index of 1.25 over three years for 629 eyes, with no reported cases of pupillary block or pigment dispersion and a low incidence of anterior subcapsular cataract at 0.16%, further reinforcing the safety and efficacy of EVO ICL.
See More
FDA Approves Expanded Age Indication for Staar Surgical's EVO ICL
- Expanded Age Indication: The FDA has approved Staar Surgical's EVO ICL for patients aged 21 to 60, expanding the potential market by nearly 8 million refractive patients, significantly enhancing growth opportunities.
- Clinical Trial Safety: The three-year follow-up of 629 eyes in the FDA clinical trial demonstrated a strong safety profile with a safety index of 1.25, no reported cases of pupillary block or pigment dispersion, and a low anterior subcapsular cataract incidence of 0.16%.
- Shifting Market Trends: The EVO ICL has become the leading procedure for patients with -8.0 diopters and above, with over half of U.S. vision correction consumers now interested in alternatives to LASIK, indicating a shift towards lens-based solutions.
- Stock Performance Analysis: Despite a 2.28% premarket increase to $16.57 following the FDA approval, the stock remains below its 20-day and 100-day simple moving averages, indicating a bearish trend, with key support at $14.50 to monitor closely.
See More
Wall Street Analysts Adjust Ratings
- Analyst Rating Changes: Top Wall Street analysts have adjusted their ratings on several companies, indicating a shift in market sentiment that could influence investor decisions and market trends.
- Upgrades and Downgrades: While specific stock names are not mentioned, such rating changes typically lead to price fluctuations in the affected stocks, prompting investors to closely monitor these adjustments for portfolio optimization.
- Market Reaction Expectations: Analyst rating adjustments may trigger short-term market reactions, especially when investor sentiment is sensitive towards certain stocks, thereby impacting overall market sentiment.
- Information Access Channels: Investors can access a comprehensive view of rating changes through Benzinga's analyst ratings page, enabling them to make more informed investment decisions.
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STAAR Surgical Appoints Interim Co-CEOs Following CEO Exit
- Executive Changes: STAAR Surgical announced that effective February 1, COO Warren Foust and CFO Deborah Andrews will serve as interim Co-CEOs following the exit of the previous CEO in January, demonstrating the company's agility in responding to leadership transitions.
- Search Committee Formation: The company has established a search committee to find the next permanent CEO, considering both internal and external candidates, indicating a proactive approach to ensuring leadership stability and ongoing development while seeking a suitable long-term leader.
- Stock Performance: As of last Friday, STAAR shares closed at $18.95, up 0.05% on Nasdaq, reflecting a relatively stable market reaction to the executive changes without significant impact on stock price.
- Strategic Implications: This executive transition and search process not only affects the company's governance structure but may also have profound implications for future business direction and strategic decisions, particularly in finding a leader capable of driving innovation and growth.
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William Blair Initiates Coverage on Alcon Inc. with Market Perform Rating
- Market Perform Rating: William Blair initiated coverage on Alcon Inc. (NYSE: ALC) with a Market Perform rating on Friday, indicating a neutral outlook on the company's future performance and reflecting a cautious view on its current stock price.
- Growth Drivers: Over the past two years, Alcon has aggressively driven revenue growth through increased R&D spending and several acquisitions, with analysts noting a robust product pipeline despite the stock trading at a roughly 25% premium to historical levels.
- Equipment Market Opportunity: Alcon's equipment segment accounts for about 10% of sales, with the upcoming launches of the UNITY surgical platforms in 2025 and 2026 expected to be significant growth drivers, particularly as customers replace aging systems.
- Consumables Growth Outlook: Consumables are projected to accelerate to about 7% growth in 2026, up from 5% in 2025, primarily driven by the premium-priced UNITY consumables, which enhances Alcon's competitive position in the market.
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Activist Investors Target Staar Surgical, Alumis, and Other Stocks
Increased Investments: There has been a notable rise in holdings across various sectors, indicating a growing confidence among investors.
Market Trends: The increase in holdings reflects broader market trends, suggesting potential growth opportunities in the near future.
See More
FDA Expands EVO ICL Age Indication to 60 Years
- Market Expansion: The FDA's approval to extend the age range for EVO ICL to 21-60 years opens access to nearly 8 million additional refractive patients, significantly enlarging STAAR Surgical's potential customer base in the U.S. market.
- Shift in Surgical Preference: As demand for laser refractive surgeries declines by nearly 40%, EVO ICL implantations continue to grow, with over 53% of patients expressing interest in alternatives to LASIK, indicating a meaningful shift in patient preferences for vision correction methods.
- Leading Treatment for High Myopia: EVO ICL has become the most performed refractive procedure for patients with -8.0 diopters and above, capturing 72% of the market share, demonstrating that this technology is reshaping the treatment paradigm for high myopia to meet increasing demand.
- Long-Term Safety Validation: FDA clinical trials indicate a safety index of 1.25 over three years for 629 eyes, with no reported cases of pupillary block or pigment dispersion and a low incidence of anterior subcapsular cataract at 0.16%, further reinforcing the safety and efficacy of EVO ICL.
See More
FDA Approves Expanded Age Indication for Staar Surgical's EVO ICL
- Expanded Age Indication: The FDA has approved Staar Surgical's EVO ICL for patients aged 21 to 60, expanding the potential market by nearly 8 million refractive patients, significantly enhancing growth opportunities.
- Clinical Trial Safety: The three-year follow-up of 629 eyes in the FDA clinical trial demonstrated a strong safety profile with a safety index of 1.25, no reported cases of pupillary block or pigment dispersion, and a low anterior subcapsular cataract incidence of 0.16%.
- Shifting Market Trends: The EVO ICL has become the leading procedure for patients with -8.0 diopters and above, with over half of U.S. vision correction consumers now interested in alternatives to LASIK, indicating a shift towards lens-based solutions.
- Stock Performance Analysis: Despite a 2.28% premarket increase to $16.57 following the FDA approval, the stock remains below its 20-day and 100-day simple moving averages, indicating a bearish trend, with key support at $14.50 to monitor closely.
See More
Wall Street Analysts Adjust Ratings
- Analyst Rating Changes: Top Wall Street analysts have adjusted their ratings on several companies, indicating a shift in market sentiment that could influence investor decisions and market trends.
- Upgrades and Downgrades: While specific stock names are not mentioned, such rating changes typically lead to price fluctuations in the affected stocks, prompting investors to closely monitor these adjustments for portfolio optimization.
- Market Reaction Expectations: Analyst rating adjustments may trigger short-term market reactions, especially when investor sentiment is sensitive towards certain stocks, thereby impacting overall market sentiment.
- Information Access Channels: Investors can access a comprehensive view of rating changes through Benzinga's analyst ratings page, enabling them to make more informed investment decisions.
See More
STAAR Surgical Appoints Interim Co-CEOs Following CEO Exit
- Executive Changes: STAAR Surgical announced that effective February 1, COO Warren Foust and CFO Deborah Andrews will serve as interim Co-CEOs following the exit of the previous CEO in January, demonstrating the company's agility in responding to leadership transitions.
- Search Committee Formation: The company has established a search committee to find the next permanent CEO, considering both internal and external candidates, indicating a proactive approach to ensuring leadership stability and ongoing development while seeking a suitable long-term leader.
- Stock Performance: As of last Friday, STAAR shares closed at $18.95, up 0.05% on Nasdaq, reflecting a relatively stable market reaction to the executive changes without significant impact on stock price.
- Strategic Implications: This executive transition and search process not only affects the company's governance structure but may also have profound implications for future business direction and strategic decisions, particularly in finding a leader capable of driving innovation and growth.
See More
William Blair Initiates Coverage on Alcon Inc. with Market Perform Rating
- Market Perform Rating: William Blair initiated coverage on Alcon Inc. (NYSE: ALC) with a Market Perform rating on Friday, indicating a neutral outlook on the company's future performance and reflecting a cautious view on its current stock price.
- Growth Drivers: Over the past two years, Alcon has aggressively driven revenue growth through increased R&D spending and several acquisitions, with analysts noting a robust product pipeline despite the stock trading at a roughly 25% premium to historical levels.
- Equipment Market Opportunity: Alcon's equipment segment accounts for about 10% of sales, with the upcoming launches of the UNITY surgical platforms in 2025 and 2026 expected to be significant growth drivers, particularly as customers replace aging systems.
- Consumables Growth Outlook: Consumables are projected to accelerate to about 7% growth in 2026, up from 5% in 2025, primarily driven by the premium-priced UNITY consumables, which enhances Alcon's competitive position in the market.
See More
Activist Investors Target Staar Surgical, Alumis, and Other Stocks
Increased Investments: There has been a notable rise in holdings across various sectors, indicating a growing confidence among investors.
Market Trends: The increase in holdings reflects broader market trends, suggesting potential growth opportunities in the near future.
See More
