FDA Approves Expanded Age Indication for Staar Surgical's EVO ICL
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Feb 18 2026
0mins
Should l Buy STAA?
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: 19.050
Low
30.75
Averages
30.75
High
30.75
Current: 19.050
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.
STAAR Surgical to Announce Q4 Earnings on March 3
- Earnings Announcement: STAAR Surgical is set to release its Q4 earnings on March 3 after market close, with a consensus EPS estimate of $0.17, reflecting a significant year-over-year increase of 124.6%, which could boost investor confidence.
- Revenue Expectations: The company anticipates Q4 revenue of $75.05 million, representing a 53.3% year-over-year growth, indicating strong market competitiveness and rising product demand.
- Performance Forecast Revisions: Over the past year, STAAR Surgical has beaten EPS estimates 50% of the time, while only achieving a 25% beat rate on revenue estimates, highlighting volatility in its profitability.
- Shareholder Activity: Yunqi Capital recently purchased 750,000 shares of STAAR Surgical at $21.53 per share, indicating institutional investor confidence in the company's future performance, which may positively impact the stock price.
See More
STAAR Surgical Reports Reduced Q4 Net Loss Amid Sales Growth
- Net Loss Improvement: STAAR Surgical reported a net loss of $18.3 million for Q4 2025, translating to a loss of $0.37 per share, which is a significant improvement from a net loss of $34.2 million or $0.69 per share in the same quarter last year, primarily due to higher gross profits and lower operating expenses.
- Sales Growth: The company achieved net sales of $57.8 million in Q4, an 18.1% increase from $49.0 million in the prior year quarter, with the growth largely driven by strong sales in the Chinese market.
- Cost Control: Although merger and restructuring expenses impacted financial performance, STAAR Surgical effectively improved its overall financial condition by reducing operating expenses, demonstrating success in cost management strategies.
- Market Outlook: With the sales growth in China, STAAR Surgical is positioned to continue benefiting from increased demand in the region, which is expected to further enhance the company's overall performance.
See More
STAAR Surgical Reports Q4 Earnings Miss
- Earnings Miss: STAAR Surgical reported a Q4 GAAP EPS of -$0.37, missing expectations by $0.41, highlighting significant challenges in profitability for the company.
- Weak Revenue Growth: Despite an 18.1% year-over-year revenue increase to $57.8 million in Q4, the figure fell short of expectations by $17.25 million, reflecting soft market demand and intensified competition.
- Annual Performance Decline: For fiscal year 2025, net sales totaled $239.4 million, down 23.7% year-over-year, while net sales excluding China were $161.7 million, up 6.6%, indicating relative resilience in international markets.
- Widening Net Loss: The company reported a net loss of $80.4 million, or $1.62 per share, significantly increasing from a net loss of $20.2 million a year ago, indicating greater financial pressure on the company.
See More
STAAR Surgical to Release Q4 and FY 2025 Financial Results
- Earnings Release Schedule: STAAR Surgical will release its fourth quarter and fiscal year 2025 financial results on March 3, 2026, after market close, demonstrating the company's commitment to financial transparency.
- Conference Call Details: The company will host a conference call at 5:30 PM ET on the same day to discuss fiscal year 2025 operations and financial results, expected to cover critical topics such as recovery in China and operational improvements, reflecting STAAR's keen awareness of market dynamics.
- Innovation and Expansion: The call will provide updates on manufacturing expansion in Switzerland and the innovation pipeline, indicating STAAR's ongoing investment in technology and market expansion aimed at enhancing its competitiveness in the global vision correction market.
- Long-Term Vision: Since 1982, STAAR Surgical has focused on ophthalmic surgery, selling over 3.5 million implantable lenses in 75 countries, showcasing its leadership position in the industry and confidence in future growth.
See More
STAAR Surgical Announces Q4 and FY 2025 Earnings Release Date
- Earnings Release Schedule: STAAR Surgical will release its fourth quarter and fiscal year 2025 financial results on March 3, 2026, after market close, providing crucial operational and financial data to help investors assess the company's performance.
- Conference Call Details: The company will host a conference call at 5:30 PM ET on the same day to discuss financial results and business progress, covering topics such as fiscal year 2025 operations review, inventory normalization, and cost discipline, aimed at boosting investor confidence.
- Manufacturing Expansion Update: During the call, STAAR will provide updates on its manufacturing expansion in Switzerland, indicating strategic positioning in response to global market demand recovery, which may enhance production capacity and market responsiveness.
- Innovation Pipeline Progress: The company will also share the latest developments in its innovation pipeline, showcasing ongoing R&D investments in the vision correction field, further solidifying its leadership position in the global market.
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
STAAR Surgical to Announce Q4 Earnings on March 3
- Earnings Announcement: STAAR Surgical is set to release its Q4 earnings on March 3 after market close, with a consensus EPS estimate of $0.17, reflecting a significant year-over-year increase of 124.6%, which could boost investor confidence.
- Revenue Expectations: The company anticipates Q4 revenue of $75.05 million, representing a 53.3% year-over-year growth, indicating strong market competitiveness and rising product demand.
- Performance Forecast Revisions: Over the past year, STAAR Surgical has beaten EPS estimates 50% of the time, while only achieving a 25% beat rate on revenue estimates, highlighting volatility in its profitability.
- Shareholder Activity: Yunqi Capital recently purchased 750,000 shares of STAAR Surgical at $21.53 per share, indicating institutional investor confidence in the company's future performance, which may positively impact the stock price.
See More
STAAR Surgical Reports Reduced Q4 Net Loss Amid Sales Growth
- Net Loss Improvement: STAAR Surgical reported a net loss of $18.3 million for Q4 2025, translating to a loss of $0.37 per share, which is a significant improvement from a net loss of $34.2 million or $0.69 per share in the same quarter last year, primarily due to higher gross profits and lower operating expenses.
- Sales Growth: The company achieved net sales of $57.8 million in Q4, an 18.1% increase from $49.0 million in the prior year quarter, with the growth largely driven by strong sales in the Chinese market.
- Cost Control: Although merger and restructuring expenses impacted financial performance, STAAR Surgical effectively improved its overall financial condition by reducing operating expenses, demonstrating success in cost management strategies.
- Market Outlook: With the sales growth in China, STAAR Surgical is positioned to continue benefiting from increased demand in the region, which is expected to further enhance the company's overall performance.
See More
STAAR Surgical Reports Q4 Earnings Miss
- Earnings Miss: STAAR Surgical reported a Q4 GAAP EPS of -$0.37, missing expectations by $0.41, highlighting significant challenges in profitability for the company.
- Weak Revenue Growth: Despite an 18.1% year-over-year revenue increase to $57.8 million in Q4, the figure fell short of expectations by $17.25 million, reflecting soft market demand and intensified competition.
- Annual Performance Decline: For fiscal year 2025, net sales totaled $239.4 million, down 23.7% year-over-year, while net sales excluding China were $161.7 million, up 6.6%, indicating relative resilience in international markets.
- Widening Net Loss: The company reported a net loss of $80.4 million, or $1.62 per share, significantly increasing from a net loss of $20.2 million a year ago, indicating greater financial pressure on the company.
See More
STAAR Surgical to Release Q4 and FY 2025 Financial Results
- Earnings Release Schedule: STAAR Surgical will release its fourth quarter and fiscal year 2025 financial results on March 3, 2026, after market close, demonstrating the company's commitment to financial transparency.
- Conference Call Details: The company will host a conference call at 5:30 PM ET on the same day to discuss fiscal year 2025 operations and financial results, expected to cover critical topics such as recovery in China and operational improvements, reflecting STAAR's keen awareness of market dynamics.
- Innovation and Expansion: The call will provide updates on manufacturing expansion in Switzerland and the innovation pipeline, indicating STAAR's ongoing investment in technology and market expansion aimed at enhancing its competitiveness in the global vision correction market.
- Long-Term Vision: Since 1982, STAAR Surgical has focused on ophthalmic surgery, selling over 3.5 million implantable lenses in 75 countries, showcasing its leadership position in the industry and confidence in future growth.
See More
STAAR Surgical Announces Q4 and FY 2025 Earnings Release Date
- Earnings Release Schedule: STAAR Surgical will release its fourth quarter and fiscal year 2025 financial results on March 3, 2026, after market close, providing crucial operational and financial data to help investors assess the company's performance.
- Conference Call Details: The company will host a conference call at 5:30 PM ET on the same day to discuss financial results and business progress, covering topics such as fiscal year 2025 operations review, inventory normalization, and cost discipline, aimed at boosting investor confidence.
- Manufacturing Expansion Update: During the call, STAAR will provide updates on its manufacturing expansion in Switzerland, indicating strategic positioning in response to global market demand recovery, which may enhance production capacity and market responsiveness.
- Innovation Pipeline Progress: The company will also share the latest developments in its innovation pipeline, showcasing ongoing R&D investments in the vision correction field, further solidifying its leadership position in the global market.
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
