FDA Expands Approval For Staar Surgical's Popular Implantable Lens

The U.S. Food and Drug Administration (FDA) on Tuesday approved an expanded age indication for Staar Surgical Company’s (NASDAQ:STAA) EVO/EVO+ Visian Implantable Collamer Lenses (ICL). The stock is trading higher in the premarket.

The EVO ICL was previously approved for U.S. patients 21 to 45 years old.

The FDA has approved an expanded age indication for the EVO ICL, allowing its use for patients aged 21 to 60 years old, which could potentially add nearly 8 million refractive patients to the market.

The approval follows the release of three-year clinical trial safety data, reinforcing the long-term safety profile of the EVO ICL.

Patient Preference

In the U.S., the EVO ICL has become the leading procedure for patients with -8.0 diopters and above, as laser-based procedures are declining significantly.

Recent studies indicate that over half of U.S. vision correction consumers are now interested in alternatives to LASIK, reflecting a shift in patient preferences towards lens-based solutions.

Long-Term Safety

In the FDA clinical trial, 629 eyes were followed for three years, demonstrating a strong safety profile with a safety index of 1.25 at three years, no reported cases of pupillary block or pigment dispersion, and a low incidence of anterior subcapsular cataract (0.16%).

EVO lenses are implanted in a quick, minimally invasive procedure in which the lens is positioned behind the iris and in front of the natural crystalline lens.

In January, STAAR Surgical said that it did not receive the necessary stockholder votes to approve the merger agreement with Alcon Inc. (NYSE:ALC) at the Special Meeting of Stockholders. The companies terminated the deal.

Also, Neal Bradsher and Richard LeBuhn of Broadwood Partners, along with Christopher Wang of Yunqi Capital, joined STAAR’s Board of Directors following a cooperation agreement.

Technical Analysis

Currently, the stock is trading 9.8% below its 20-day simple moving average (SMA) and 29.8% below its 100-day SMA, indicating a bearish trend in the short to medium term. Over the past 12 months, shares have decreased by 2.59% and are positioned closer to their 52-week lows than highs.

The RSI is at 22.35, which is considered oversold territory, suggesting that the stock may be undervalued at this point. Meanwhile, MACD is below its signal line, indicating bearish pressure on the stock.

The combination of oversold RSI and bearish MACD suggests mixed momentum, indicating that while the stock is oversold, the overall trend remains negative.

• Key Resistance: $18.50
• Key Support: $14.50

Earnings & Analyst Outlook

The countdown is on: Staar Surgical is set to report earnings on March 3, 2026.

• EPS Estimate: 12 cents (Up from Loss of 69 cents)
• Revenue Estimate: $75.25 million (Up from $48.95 million)

Analyst Consensus & Recent Actions: The stock carries a Hold Rating with an average price target of $27.30. Recent analyst moves include:

• Stifel: Hold (Lowers Target to $19)
• Wedbush: Initiated with Neutral (Target $26)
• Jefferies: Buy (Lowers Target to $21.50)

Top ETF Exposure

• SPDR S&P Health Care Equipment ETF (NYSE:XHE): 2.84% Weight

STAA Price Action: Staar Surgical shares were up 2.28% at $16.57 during premarket trading on Wednesday.

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