Oculis' Privosegti: A Neuroprotective Breakthrough in Acute Optic Neuritis?

The landscape of neuro-inflammation therapies is undergoing a quiet revolution, driven by a growing recognition of the need for neuroprotective interventions alongside traditional immunomodulatory approaches. Oculis' Privosegti (OCS-05), a first-in-class neuroprotective agent, has emerged as a standout candidate in this space, particularly for its recent Phase 2 ACUITY trial results in acute optic neuritis (AON). Presented at ECTRIMS 2025, the trial's findings not only underscore the drug's clinical promise but also highlight a critical unmet need in a market poised for disruption.

Clinical Efficacy: A Neuroprotective Edge

Acute optic neuritis, a hallmark of multiple sclerosis (MS) and other demyelinating diseases, has long relied on corticosteroids to manage inflammation. However, these therapies address symptoms rather than underlying neurodegeneration. Oculis' Privosegti, a synthetic analog of cromolyn sodium, targets microglial activation—a key driver of neuronal damage in AON. According to a report by Oculis, the ACUITY trial demonstrated a 43% improvement in GCIPL thickness and a 28% improvement in RNFL thickness at 3 months, with sustained benefits through 6 months Oculis Announces Presentation of Phase 2 ACUITY Trial Results with Privosegti in Acute Optic Neuritis at ECTRIMS 2025 Congress^[1]. These structural metrics, critical for long-term visual outcomes, suggest Privosegti's ability to halt—or even reverse—neurodegenerative processes.

Complementing these structural gains, the trial reported an 18-letter improvement in low-contrast visual acuity, a clinically meaningful threshold for functional recovery Oculis Announces Presentation of Phase 2 ACUITY Trial Results with Privosegti in Acute Optic Neuritis at ECTRIMS 2025 Congress^[1]. Such outcomes position Privosegti as a potential paradigm shift in AON treatment, addressing both inflammation and neuroprotection. As noted in a clinical overview by Oculis, this dual mechanism could reduce the risk of subsequent MS diagnoses, a significant downstream value proposition OCS-05: Acute Optic Neuritis - Symptoms & Treatment^[2].

Market Potential: Filling a $1.2 Billion Gap

While direct market data for AON therapies remains sparse, broader trends in neuro-inflammation and MS treatments offer context. The global MS market, valued at over $20 billion in 2025, is increasingly focused on neuroprotection, with investors prioritizing therapies that slow disability progression. AON, affecting approximately 15-20% of MS patients annually, represents a niche but high-impact segment. Assuming a conservative 5% adoption rate for Privosegti in AON—a condition with no approved neuroprotective therapies—the drug could capture a $1.2 billion market segment by 2030, assuming an average treatment cost of $50,000 per patient.

This projection hinges on several factors, including regulatory approval and reimbursement dynamics. However, the trial's positive safety profile—no serious adverse events reported—strengthens its commercial viability. In a competitive landscape dominated by high-cost biologics, Privosegti's potential as an injectable therapy with a favorable risk-benefit ratio could appeal to payers and providers alike.

Industry Trends: Neuroprotection as the Next Frontier

The ACUITY trial aligns with a broader industry pivot toward neuroprotection. Recent failures of anti-inflammatory monotherapies in MS trials have intensified interest in agents that preserve neural integrity. For instance, Biogen's siponimod and Novartis' ozanimod, while effective in relapse reduction, offer limited neuroprotective benefits. Privosegti's mechanism—modulating microglial activity—addresses a root cause of neuronal damage, a differentiator that could redefine treatment algorithms.

Moreover, the trial's success underscores the growing importance of retinal imaging biomarkers in neurology. The use of optical coherence tomography (OCT) to measure GCIPL and RNFL thickness provides objective, quantifiable endpoints—a feature increasingly demanded by regulators and investors. As noted in a top-line results report by Ophthalmology Times, these biomarkers could accelerate drug development by enabling earlier efficacy assessments Oculis Releases Positive Topline Results from Phase 2 ACUITY Trial Evaluating OCS-05 in Acute Optic Neuritis^[3].

Risks and Considerations

Despite its promise, Privosegti's path to commercialization is not without hurdles. The absence of head-to-head trials against existing therapies limits direct comparisons, and the Phase 2 trial's small sample size raises questions about generalizability. Additionally, the neuro-inflammation space is highly competitive, with companies like Roche and Sanofi investing heavily in next-gen MS therapies. Oculis will need to secure robust Phase 3 data and navigate payer resistance to premium pricing.

Conclusion: A Neuroprotective Catalyst

Oculis' Privosegti represents more than a novel therapy for AON—it is a harbinger of a new era in neuro-inflammation, where neuroprotection is no longer an afterthought but a core objective. With its compelling Phase 2 results and alignment with industry trends, the drug has the potential to redefine treatment standards while capturing a lucrative market segment. For investors, the ACUITY trial's success signals a rare confluence of clinical innovation and commercial opportunity, particularly as the MS and neuro-inflammation sectors continue to evolve.