Oculis' Privosegtor Receives FDA Breakthrough Therapy Designation
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jan 06 2026
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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 over the next 12 months. According to Wall Street analysts, the average 1-year price target for OCUL is 23.43 USD with a low forecast of 20.00 USD and a high forecast of 31.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
8 Analyst Rating
8 Buy
0 Hold
0 Sell
Strong Buy
Current: 9.950
Low
20.00
Averages
23.43
High
31.00
Current: 9.950
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.
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- Stock Surge: Ocular Therapeutix shares surged approximately 21% in premarket trading, rising from $10.50 to $11.20, reflecting positive market sentiment regarding the acquisition news and investor optimism about the company's future.
- Market Potential: Ocular's tyrosine kinase inhibitor Axpaxli is in late-stage development for wet age-related macular degeneration (AMD), with topline data from the SOL-1 study expected in Q1 2026, potentially providing Sanofi with an entry into this lucrative market.
- Mixed Technical Indicators: Currently, Ocular's stock is trading 1.7% above its 20-day simple moving average but 0.7% below its 50-day moving average, indicating mixed short-term technical signals, although shares have increased approximately 48.34% over the past year, suggesting cautious optimism among investors.
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