Oculis OCS-01 Trials Fail to Meet Primary Endpoint
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 7 hours ago
0mins
Source: NASDAQ.COM
- Trial Results: Oculis Holding AG's OCS-01 eye drops failed to meet the primary endpoint in the Phase 3 DIAMOND-1 and DIAMOND-2 trials for diabetic macular edema, as the mean change in best corrected visual acuity (BCVA) at Week 52 was not achieved, indicating a lack of efficacy.
- Secondary Endpoint Failure: The proportion of patients achieving a 15-letter gain in BCVA also fell short of expectations in both studies, suggesting limited effectiveness of OCS-01 in improving vision, which may impact future market acceptance.
- Safety Assessment: Despite the efficacy shortcomings, OCS-01 was well tolerated with no unexpected adverse events reported, and the overall safety profile was consistent with earlier studies, indicating favorable tolerability that could support future research.
- Stock Price Reaction: Following the trial results, Oculis's stock price plummeted, closing at $22.71 on May 29, down 23.42%, and further declining to $15.01 in after-hours trading, a drop of 33.89%, reflecting market pessimism regarding the drug's prospects.
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Analyst Views on OCS
Wall Street analysts forecast OCS stock price to rise
6 Analyst Rating
6 Buy
0 Hold
0 Sell
Strong Buy
Current: 29.650
Low
29.00
Averages
40.00
High
55.00
Current: 29.650
Low
29.00
Averages
40.00
High
55.00
About OCS
Oculis Holding AG is a Switzerland-based company primally engaged in biotechnology sector. The Company is focused on the development of eye disease treatment for ophthalmology. It includes OCS-01, based on the OPTIREACH technology, a topical retinal candidate for diabetic macular edema (DME); OCS-02, a topical biologic candidate for dry eye disease (DED) in a form of a single chain antibody fragment; and OCS-05, a disease modifying candidate for acute optic neuritis (AON) and for other neuro-ophtha disorders such as glaucoma, diabetic retinopathy, geographic atrophy, and neurotrophic keratitis. The Company have operations in the USA, Europe and China. Ocullis deliver treatments to patients worldwide.
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.
Oculis OCS-01 Trials Fail to Meet Primary Endpoint
- Trial Results: Oculis Holding AG's OCS-01 eye drops failed to meet the primary endpoint in the Phase 3 DIAMOND-1 and DIAMOND-2 trials for diabetic macular edema, as the mean change in best corrected visual acuity (BCVA) at Week 52 was not achieved, indicating a lack of efficacy.
- Secondary Endpoint Failure: The proportion of patients achieving a 15-letter gain in BCVA also fell short of expectations in both studies, suggesting limited effectiveness of OCS-01 in improving vision, which may impact future market acceptance.
- Safety Assessment: Despite the efficacy shortcomings, OCS-01 was well tolerated with no unexpected adverse events reported, and the overall safety profile was consistent with earlier studies, indicating favorable tolerability that could support future research.
- Stock Price Reaction: Following the trial results, Oculis's stock price plummeted, closing at $22.71 on May 29, down 23.42%, and further declining to $15.01 in after-hours trading, a drop of 33.89%, reflecting market pessimism regarding the drug's prospects.
See More
OCS-01 Fails to Meet Primary Endpoint in Phase 3 Trials
- Trial Results: OCS-01 failed to meet the primary endpoint of improving visual acuity in both Phase 3 DIAMOND-1 and DIAMOND-2 trials, although the treatment did reduce retinal thickness compared to placebo, indicating some efficacy; this failure led to a more than 23% drop in the company's stock price during Friday's trading.
- Patient Enrollment: Over 800 patients were enrolled across 119 study sites in the U.S. and other countries for these trials lasting 52 weeks, highlighting the complexity and challenges of large-scale clinical trials, and the unmet primary goal may impact future research directions and investor confidence.
- Strategic Shift: Oculis announced it will not proceed with an FDA filing for OCS-01 in diabetic macular edema and will redirect resources to other late-stage programs, including the Privosegtor PIONEER trial for optic neuropathies and the Licaminlimab PREDICT-1 study in dry eye disease, demonstrating the company's adaptability in the face of setbacks.
- Market Sentiment Analysis: Despite the significant drop in OCS's stock price, sentiment on Stocktwits remains “bullish,” with the stock having gained 18% over the past 12 months, indicating a level of market confidence in the company's future potential that may influence investor decisions.
See More
Oculis Holding Shares Plunge Over 20% After Failed Trials for OCS-01
- Trial Failures: Oculis Holding announced the failure of its late-stage trials DIAMOND-1 and DIAMOND-2 for its lead candidate OCS-01 targeting diabetic macular edema, resulting in a more than 20% drop in share price on Friday.
- Trial Scale and Objectives: The two international trials involved over 800 patients and aimed to assess the average 52-week change in best-corrected visual acuity, but failed to meet the primary endpoint, indicating insufficient efficacy of the drug.
- Safety Signals: Despite the failure to meet both primary and secondary endpoints, Oculis reported that OCS-01 eye drops showed a tolerability profile consistent with prior studies, with no new safety signals detected, suggesting some potential in safety aspects.
- Strategic Reallocation: In light of this setback, Oculis has decided not to pursue an FDA filing for OCS-01 in diabetic macular edema and plans to initiate a strategic prioritization of resources to address future challenges.
See More
Oculis Phase 3 Trial Results Fall Short of Expectations
- Primary Endpoint Missed: Oculis's Phase 3 DIAMOND-1 and DIAMOND-2 trials for OCS-01 eye drops did not meet the primary endpoint of mean change in best corrected visual acuity (BCVA) at week 52, indicating a potential setback for future FDA filing plans.
- Secondary Endpoint Success: Despite the primary endpoint failure, OCS-01 demonstrated a significant and persistent reduction in retinal thickness, suggesting its potential efficacy in treating diabetic macular edema (DME) and providing a basis for further research.
- Strong Financial Position: As of March 31, 2026, Oculis reported $278 million in cash and short-term investments, ensuring a solid financial runway into the second half of 2029, which supports ongoing research and development efforts.
- Strategic Focus Shift: Oculis plans to concentrate resources on the registration trials for Privosegtor and Licaminlimab, showcasing the company's adaptability in response to clinical challenges and aiming to advance precision medicine initiatives.
See More
Oculis Secures FDA Special Protocol Assessment for Privosegtor
- FDA Agreement Confirmation: Oculis has secured a Special Protocol Assessment (SPA) from the FDA, confirming that the design of the PIONEER-1 trial meets the requirements for a future NDA submission, paving the way for Privosegtor's registration in treating optic neuritis and highlighting the company's strategic potential in neuroprotection.
- Clinical Trial Progress: The PIONEER-1 trial, as the first registrational study for Privosegtor, will evaluate its efficacy in patients with optic neuritis, with a primary endpoint of significant improvement in low-contrast visual acuity at three months, which is expected to provide robust data for future market launch.
- Significant Market Opportunity: Privosegtor is poised to become the first neuroprotective therapy for optic neuritis, with Riad Sherif noting a potential $7 billion market in acute optic neuropathies in the U.S., underscoring Oculis's strategic importance in addressing unmet medical needs.
- Positive Clinical Outcomes: In the prior ACUITY trial, Privosegtor combined with steroids demonstrated significant vision improvement without serious adverse events, laying the groundwork for its Breakthrough Therapy designation from the FDA and PRIME designation from the EMA, further enhancing its market competitiveness.
See More
Oculis Advances Non-Invasive DME Treatment Options
- Current Treatment Landscape: Diabetic macular edema (DME) primarily affects individuals around the age of 52, with 60% of patients remaining untreated one year post-diagnosis, indicating significant gaps in current treatment approaches that hinder vision recovery opportunities.
- DME AWARE Findings: The DME AWARE Delphi study underscores the critical need for non-invasive treatment options, with experts reaching consensus on prioritizing eye drops for early intervention to improve visual function and reduce inflammatory factors.
- Potential of OCS-01: Oculis's OCS-01 eye drops are in Phase 3 trials and, if successful, could become the first non-invasive treatment for DME, offering a new option for the 40% of patients who inadequately respond to existing injection therapies.
- Global Expert Consensus: The DME AWARE study, involving 25 leading retina and ophthalmology experts, established a global consensus on the urgent need for non-invasive therapies and early intervention in DME management, potentially driving transformative changes in future clinical practices.
See More
Oculis OCS-01 Trials Fail to Meet Primary Endpoint
- Trial Results: Oculis Holding AG's OCS-01 eye drops failed to meet the primary endpoint in the Phase 3 DIAMOND-1 and DIAMOND-2 trials for diabetic macular edema, as the mean change in best corrected visual acuity (BCVA) at Week 52 was not achieved, indicating a lack of efficacy.
- Secondary Endpoint Failure: The proportion of patients achieving a 15-letter gain in BCVA also fell short of expectations in both studies, suggesting limited effectiveness of OCS-01 in improving vision, which may impact future market acceptance.
- Safety Assessment: Despite the efficacy shortcomings, OCS-01 was well tolerated with no unexpected adverse events reported, and the overall safety profile was consistent with earlier studies, indicating favorable tolerability that could support future research.
- Stock Price Reaction: Following the trial results, Oculis's stock price plummeted, closing at $22.71 on May 29, down 23.42%, and further declining to $15.01 in after-hours trading, a drop of 33.89%, reflecting market pessimism regarding the drug's prospects.
See More
OCS-01 Fails to Meet Primary Endpoint in Phase 3 Trials
- Trial Results: OCS-01 failed to meet the primary endpoint of improving visual acuity in both Phase 3 DIAMOND-1 and DIAMOND-2 trials, although the treatment did reduce retinal thickness compared to placebo, indicating some efficacy; this failure led to a more than 23% drop in the company's stock price during Friday's trading.
- Patient Enrollment: Over 800 patients were enrolled across 119 study sites in the U.S. and other countries for these trials lasting 52 weeks, highlighting the complexity and challenges of large-scale clinical trials, and the unmet primary goal may impact future research directions and investor confidence.
- Strategic Shift: Oculis announced it will not proceed with an FDA filing for OCS-01 in diabetic macular edema and will redirect resources to other late-stage programs, including the Privosegtor PIONEER trial for optic neuropathies and the Licaminlimab PREDICT-1 study in dry eye disease, demonstrating the company's adaptability in the face of setbacks.
- Market Sentiment Analysis: Despite the significant drop in OCS's stock price, sentiment on Stocktwits remains “bullish,” with the stock having gained 18% over the past 12 months, indicating a level of market confidence in the company's future potential that may influence investor decisions.
See More
Oculis Holding Shares Plunge Over 20% After Failed Trials for OCS-01
- Trial Failures: Oculis Holding announced the failure of its late-stage trials DIAMOND-1 and DIAMOND-2 for its lead candidate OCS-01 targeting diabetic macular edema, resulting in a more than 20% drop in share price on Friday.
- Trial Scale and Objectives: The two international trials involved over 800 patients and aimed to assess the average 52-week change in best-corrected visual acuity, but failed to meet the primary endpoint, indicating insufficient efficacy of the drug.
- Safety Signals: Despite the failure to meet both primary and secondary endpoints, Oculis reported that OCS-01 eye drops showed a tolerability profile consistent with prior studies, with no new safety signals detected, suggesting some potential in safety aspects.
- Strategic Reallocation: In light of this setback, Oculis has decided not to pursue an FDA filing for OCS-01 in diabetic macular edema and plans to initiate a strategic prioritization of resources to address future challenges.
See More
Oculis Phase 3 Trial Results Fall Short of Expectations
- Primary Endpoint Missed: Oculis's Phase 3 DIAMOND-1 and DIAMOND-2 trials for OCS-01 eye drops did not meet the primary endpoint of mean change in best corrected visual acuity (BCVA) at week 52, indicating a potential setback for future FDA filing plans.
- Secondary Endpoint Success: Despite the primary endpoint failure, OCS-01 demonstrated a significant and persistent reduction in retinal thickness, suggesting its potential efficacy in treating diabetic macular edema (DME) and providing a basis for further research.
- Strong Financial Position: As of March 31, 2026, Oculis reported $278 million in cash and short-term investments, ensuring a solid financial runway into the second half of 2029, which supports ongoing research and development efforts.
- Strategic Focus Shift: Oculis plans to concentrate resources on the registration trials for Privosegtor and Licaminlimab, showcasing the company's adaptability in response to clinical challenges and aiming to advance precision medicine initiatives.
See More
Oculis Secures FDA Special Protocol Assessment for Privosegtor
- FDA Agreement Confirmation: Oculis has secured a Special Protocol Assessment (SPA) from the FDA, confirming that the design of the PIONEER-1 trial meets the requirements for a future NDA submission, paving the way for Privosegtor's registration in treating optic neuritis and highlighting the company's strategic potential in neuroprotection.
- Clinical Trial Progress: The PIONEER-1 trial, as the first registrational study for Privosegtor, will evaluate its efficacy in patients with optic neuritis, with a primary endpoint of significant improvement in low-contrast visual acuity at three months, which is expected to provide robust data for future market launch.
- Significant Market Opportunity: Privosegtor is poised to become the first neuroprotective therapy for optic neuritis, with Riad Sherif noting a potential $7 billion market in acute optic neuropathies in the U.S., underscoring Oculis's strategic importance in addressing unmet medical needs.
- Positive Clinical Outcomes: In the prior ACUITY trial, Privosegtor combined with steroids demonstrated significant vision improvement without serious adverse events, laying the groundwork for its Breakthrough Therapy designation from the FDA and PRIME designation from the EMA, further enhancing its market competitiveness.
See More
Oculis Advances Non-Invasive DME Treatment Options
- Current Treatment Landscape: Diabetic macular edema (DME) primarily affects individuals around the age of 52, with 60% of patients remaining untreated one year post-diagnosis, indicating significant gaps in current treatment approaches that hinder vision recovery opportunities.
- DME AWARE Findings: The DME AWARE Delphi study underscores the critical need for non-invasive treatment options, with experts reaching consensus on prioritizing eye drops for early intervention to improve visual function and reduce inflammatory factors.
- Potential of OCS-01: Oculis's OCS-01 eye drops are in Phase 3 trials and, if successful, could become the first non-invasive treatment for DME, offering a new option for the 40% of patients who inadequately respond to existing injection therapies.
- Global Expert Consensus: The DME AWARE study, involving 25 leading retina and ophthalmology experts, established a global consensus on the urgent need for non-invasive therapies and early intervention in DME management, potentially driving transformative changes in future clinical practices.
See More
