Oculis' Privosegtor Receives FDA Breakthrough Therapy Designation
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jan 06 2026
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Should l Buy OCUL?
Oculis Holding announced that its neuroprotective candidate Privosegtor was granted breakthrough therapy designation by the U.S. Food and Drug Administration for treatment of optic neuritis. The FDA's Breakthrough Therapy Designation for Privosegtor is supported by visual-function results from the Phase 2 ACUITY trial in optic neuritis. In the trial, Privosegtor delivered substantial improvement in LCVA along with consistent anatomical and biological benefits compared with placebo, reinforcing its potential as a neuroprotective treatment across both neuro-ophthalmic and neurological diseases. In the ACUITY trial, Privosegtor produced substantial vision improvements on the 2.5% ETDRS Low Contrast Letter Acuity chart. Following a successful meeting with the FDA in 2025, Oculis launched the PIONEER program, which includes three pivotal trials to support registration plans for Privosegtor in ON and a second rare neuro-ophthalmic disease, NAION. The first trial in the program, PIONEER-1 in ON, was initiated in Q4 last year. This global study spans three continents. Sites activation is underway, and enrollment is expected to begin shortly. Shares of Oculis are up 9% in premarket trading.
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Analyst Views on OCUL
Wall Street analysts forecast OCUL stock price to rise
8 Analyst Rating
8 Buy
0 Hold
0 Sell
Strong Buy
Current: 6.880
Low
20.00
Averages
23.43
High
31.00
Current: 6.880
Low
20.00
Averages
23.43
High
31.00
About OCUL
Ocular Therapeutix, Inc. is a fully-integrated biopharmaceutical company. AXPAXLI, the Company's investigational product candidate for retinal disease, is an axitinib intravitreal hydrogel based on its ELUTYX bioresorbable hydrogel-based formulation technology. Its pipeline also leverages the ELUTYX technology in its commercial product DEXTENZA, a corticosteroid for the treatment of ocular inflammation and pain following ophthalmic surgery in adults and pediatric patients, and ocular itching associated with allergic conjunctivitis in adults and pediatric patients aged two years or older, and in its investigational product candidate PAXTRAVA, which is a travoprost intracameral hydrogel for the treatment of open-angle glaucoma or ocular hypertension. The ELUTYX technology provides delivery solutions for durable therapies for wet age-related macular degeneration (wet AMD), NPDR, DME, proliferative diabetic retinopathy, retinal vein occlusion, and other diseases and conditions of the eye.
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.
OCULAR THERAPEUTIX STOCK PLUMMETS 23.5% FOLLOWING RELEASE OF LATE-STAGE EYE DISEASE TRIAL RESULTS
- Stock Price Decline: Ocular Therapeutix shares fell by 23.5% following recent reports related to a late-stage trial for an eye disease treatment.
- Trial Data Impact: The decline in stock price is attributed to concerns raised by the trial data, which may affect investor confidence and future prospects for the company.
See More
Investigation into Ocular Therapeutix Investor Claims
- Investigation Launched: Johnson Fistel, PLLP is investigating potential claims on behalf of Ocular Therapeutix, Inc. investors, focusing on whether executive officers violated federal securities laws, which may lead to recovery of investor losses.
- Trial Results Disclosure: On February 17, 2026, Ocular announced topline results from its SOL-1 Phase 3 trial, revealing that 74% of patients maintained vision at nine months; however, following this announcement, the stock price plummeted approximately 27%, indicating negative market sentiment.
- Investor Loss Alert: Following the trial results, investors who suffered losses on Ocular stock are encouraged by Johnson Fistel to join the investigation, highlighting the firm's commitment to protecting investor rights and seeking potential legal remedies.
- Law Firm Background: Johnson Fistel, PLLP is a nationally recognized shareholder rights law firm, ranked among the Top 10 Plaintiff Law Firms in 2024, having recovered approximately $90.725 million for clients, showcasing its expertise in securities law and investor advocacy.
See More
U.S. Stocks Mostly Lower, Nasdaq Drops Over 50 Points
- Market Performance: U.S. stocks traded mostly lower on Tuesday, with the Nasdaq Composite falling over 50 points, and the S&P 500 dropping 0.13% to 6,827.16, indicating a cautious investor sentiment amid market weakness.
- Company Highlights: Medtronic PLC (NYSE:MDT) reported an adjusted EPS of $1.36 for Q3, exceeding market expectations of $1.33, with quarterly sales of $9.017 billion surpassing the $8.905 billion forecast, showcasing the company's strong earnings capability.
- Sector Dynamics: Financial shares gained 0.9%, while materials stocks fell by 2%, reflecting a divergence in market performance as investors may be seeking more defensive investment opportunities amidst volatility.
- Economic Indicators: According to ADP Research, U.S. private employers added an average of 10,250 jobs per week during the four weeks ending January 31, up from 7,750 in the previous period, indicating an improving labor market trend.
See More
Ocular Therapeutix Shares Drop Following Axpaxli Trial Data Disappointment
- Clinical Trial Results: Ocular Therapeutix reported that 74.1% of patients maintained vision at Week 36 in the SOL-1 Phase 3 trial for Axpaxli, compared to 65.9% in the Eylea group, with a risk difference of 17.5% (p=0.0006); however, the durability advantage fell short of expectations, potentially impacting its commercial outlook.
- Next Steps: The company intends to submit a New Drug Application (NDA) based on the SOL-1 data, and if approved, Axpaxli could become the first tyrosine kinase inhibitor (TKI) commercialized for wet AMD, potentially being the only therapy with a superiority label, which holds significant strategic implications.
- Market Reaction: Ocular Therapeutix shares fell 26.46% in premarket trading, currently priced at $6.62, reflecting market disappointment over the Axpaxli data, despite a 23.33% increase over the past 12 months, indicating a generally positive long-term trend.
- Analyst Ratings: The stock maintains a Buy rating with an average price target of $21.00, with Chardan Capital and Needham keeping their targets unchanged, while HC Wainwright raised its target to $21.00, reflecting analysts' optimistic outlook for the future.
See More
Ocular Therapeutix Releases Axpaxli Trial Data, Stock Drops 22%
- Clinical Trial Results: Ocular Therapeutix's SOL-1 Phase 3 trial showed that approximately 74% of patients on Axpaxli maintained vision at Week 36, compared to about 56% for aflibercept, indicating a significant therapeutic advantage for Axpaxli in treating wet age-related macular degeneration.
- Safety Assessment: The company reported that the intravitreal implant of Axpaxli was generally well tolerated, with no serious ocular or systemic adverse events related to the drug, which lays a solid foundation for its future market introduction.
- Regulatory Submission Plans: Ocular Therapeutix intends to submit a New Drug Application to the FDA for Axpaxli pending regulatory feedback, and if approved, it will be the first TKI available in the U.S. for wet AMD, representing substantial market potential.
- Market Reaction: Despite the encouraging trial results, Ocular Therapeutix's stock fell approximately 22% in premarket trading, reflecting market caution regarding the drug's future commercialization prospects.
See More
U.S. Stock Futures Fluctuate Amid Government Shutdown Impact
- Market Fluctuations: U.S. stock futures showed volatility on Tuesday following a mixed close on Friday, with the S&P 500 down 1.4%, the Dow slipping 1.2%, and the Nasdaq declining 2.1% last week, reflecting cautious investor sentiment amid uncertainty.
- Government Shutdown Impact: The failure of Congressional Democrats and the Trump administration to reach a funding deal through September has triggered a partial government shutdown, which could exacerbate market instability and undermine investor confidence.
- Bond Yields: The 10-year Treasury bond yield stands at 4.02%, while the two-year bond yield is at 3.39%, indicating market expectations for future interest rate policies, with the CME Group's FedWatch tool showing a 90.2% likelihood of rates remaining unchanged in March.
- Stock Performance: Ocular Therapeutix's stock surged 33.56% ahead of its clinical trial data release for dry eye disease, while ZIM Integrated Shipping Services rose 34.46% following its acquisition agreement with Hapag-Lloyd, highlighting positive market reactions in specific sectors.
See More
OCULAR THERAPEUTIX STOCK PLUMMETS 23.5% FOLLOWING RELEASE OF LATE-STAGE EYE DISEASE TRIAL RESULTS
- Stock Price Decline: Ocular Therapeutix shares fell by 23.5% following recent reports related to a late-stage trial for an eye disease treatment.
- Trial Data Impact: The decline in stock price is attributed to concerns raised by the trial data, which may affect investor confidence and future prospects for the company.
See More
Investigation into Ocular Therapeutix Investor Claims
- Investigation Launched: Johnson Fistel, PLLP is investigating potential claims on behalf of Ocular Therapeutix, Inc. investors, focusing on whether executive officers violated federal securities laws, which may lead to recovery of investor losses.
- Trial Results Disclosure: On February 17, 2026, Ocular announced topline results from its SOL-1 Phase 3 trial, revealing that 74% of patients maintained vision at nine months; however, following this announcement, the stock price plummeted approximately 27%, indicating negative market sentiment.
- Investor Loss Alert: Following the trial results, investors who suffered losses on Ocular stock are encouraged by Johnson Fistel to join the investigation, highlighting the firm's commitment to protecting investor rights and seeking potential legal remedies.
- Law Firm Background: Johnson Fistel, PLLP is a nationally recognized shareholder rights law firm, ranked among the Top 10 Plaintiff Law Firms in 2024, having recovered approximately $90.725 million for clients, showcasing its expertise in securities law and investor advocacy.
See More
U.S. Stocks Mostly Lower, Nasdaq Drops Over 50 Points
- Market Performance: U.S. stocks traded mostly lower on Tuesday, with the Nasdaq Composite falling over 50 points, and the S&P 500 dropping 0.13% to 6,827.16, indicating a cautious investor sentiment amid market weakness.
- Company Highlights: Medtronic PLC (NYSE:MDT) reported an adjusted EPS of $1.36 for Q3, exceeding market expectations of $1.33, with quarterly sales of $9.017 billion surpassing the $8.905 billion forecast, showcasing the company's strong earnings capability.
- Sector Dynamics: Financial shares gained 0.9%, while materials stocks fell by 2%, reflecting a divergence in market performance as investors may be seeking more defensive investment opportunities amidst volatility.
- Economic Indicators: According to ADP Research, U.S. private employers added an average of 10,250 jobs per week during the four weeks ending January 31, up from 7,750 in the previous period, indicating an improving labor market trend.
See More
Ocular Therapeutix Shares Drop Following Axpaxli Trial Data Disappointment
- Clinical Trial Results: Ocular Therapeutix reported that 74.1% of patients maintained vision at Week 36 in the SOL-1 Phase 3 trial for Axpaxli, compared to 65.9% in the Eylea group, with a risk difference of 17.5% (p=0.0006); however, the durability advantage fell short of expectations, potentially impacting its commercial outlook.
- Next Steps: The company intends to submit a New Drug Application (NDA) based on the SOL-1 data, and if approved, Axpaxli could become the first tyrosine kinase inhibitor (TKI) commercialized for wet AMD, potentially being the only therapy with a superiority label, which holds significant strategic implications.
- Market Reaction: Ocular Therapeutix shares fell 26.46% in premarket trading, currently priced at $6.62, reflecting market disappointment over the Axpaxli data, despite a 23.33% increase over the past 12 months, indicating a generally positive long-term trend.
- Analyst Ratings: The stock maintains a Buy rating with an average price target of $21.00, with Chardan Capital and Needham keeping their targets unchanged, while HC Wainwright raised its target to $21.00, reflecting analysts' optimistic outlook for the future.
See More
Ocular Therapeutix Releases Axpaxli Trial Data, Stock Drops 22%
- Clinical Trial Results: Ocular Therapeutix's SOL-1 Phase 3 trial showed that approximately 74% of patients on Axpaxli maintained vision at Week 36, compared to about 56% for aflibercept, indicating a significant therapeutic advantage for Axpaxli in treating wet age-related macular degeneration.
- Safety Assessment: The company reported that the intravitreal implant of Axpaxli was generally well tolerated, with no serious ocular or systemic adverse events related to the drug, which lays a solid foundation for its future market introduction.
- Regulatory Submission Plans: Ocular Therapeutix intends to submit a New Drug Application to the FDA for Axpaxli pending regulatory feedback, and if approved, it will be the first TKI available in the U.S. for wet AMD, representing substantial market potential.
- Market Reaction: Despite the encouraging trial results, Ocular Therapeutix's stock fell approximately 22% in premarket trading, reflecting market caution regarding the drug's future commercialization prospects.
See More
U.S. Stock Futures Fluctuate Amid Government Shutdown Impact
- Market Fluctuations: U.S. stock futures showed volatility on Tuesday following a mixed close on Friday, with the S&P 500 down 1.4%, the Dow slipping 1.2%, and the Nasdaq declining 2.1% last week, reflecting cautious investor sentiment amid uncertainty.
- Government Shutdown Impact: The failure of Congressional Democrats and the Trump administration to reach a funding deal through September has triggered a partial government shutdown, which could exacerbate market instability and undermine investor confidence.
- Bond Yields: The 10-year Treasury bond yield stands at 4.02%, while the two-year bond yield is at 3.39%, indicating market expectations for future interest rate policies, with the CME Group's FedWatch tool showing a 90.2% likelihood of rates remaining unchanged in March.
- Stock Performance: Ocular Therapeutix's stock surged 33.56% ahead of its clinical trial data release for dry eye disease, while ZIM Integrated Shipping Services rose 34.46% following its acquisition agreement with Hapag-Lloyd, highlighting positive market reactions in specific sectors.
See More
