ACRO-EYE™
Tacrolimus-Based Ophthalmic Solution for Keratoconjunctivitis Sicca
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Keratoconjunctivitis Sicca — An Autoimmune Burden
KCS, commonly known as dry eye disease of autoimmune origin, is characterized by persistent ocular surface inflammation driven by aberrant T-cell activation, resulting in lacrimal gland dysfunction and progressive corneal damage.
Cyclosporine A (Restasis®, Ikervis®) is the only approved immunosuppressant for KCS in most markets, but is associated with significant burning sensation and inconsistent response rates.
ACRO-EYE™ — A Differentiated Tacrolimus Platform
Investigational Galenic FormulationProprietary ophthalmic galenic solution with Tacrolimus achieving immunomodulatory effect at 10–30x lower concentrations than systemic treatments, minimizing systemic exposure while maintaining ocular efficacy.
Greater Therapeutic Efficacy
Clinically meaningful outcomes at significantly lower doses compared to systemic alternatives.
Improved Tolerability
Reduced burning sensation upon instillation compared to Cyclosporine A, supporting chronic use.
Targeted Immunomodulation
Localized T-cell suppression without clinically relevant systemic immunosuppression.
Mechanism of Action
Tacrolimus works by binding to the immunophilin FKBP-12, forming a complex that inhibits calcineurin and blocks T-cell activation at the ocular surface.
Ocular Surface Immunomodulation
Applied topically
Forms inhibitory complex
T-cell suppression
Tear production restored
Calcineurin Inhibition
Tacrolimus binds FKBP-12; the resulting complex inhibits calcineurin, critical to T-lymphocyte activation.
NFAT Pathway Blockade
Prevents dephosphorylation of NFAT, blocking transcription of IL-2, IFN-γ, and TNF-α.
Clinical Outcomes
Lacrimal gland recovery, goblet cell restoration, increased tear production, improved tear film stability.
Real-World Clinical Evidence
Data from galenic clinical use in specialized settings. Not from regulatory clinical trials.
Patients treated in real-world galenic settings across Italy — pediatric and adult
No direct equivalent galenic ophthalmic Tacrolimus formulation available
Differentiation vs Cyclosporine A
| ACRO-EYE™ | Cyclosporine A (Restasis®/Ikervis®) | |
|---|---|---|
| Active ingredient | Tacrolimus | Cyclosporine A |
| Mechanism | Calcineurin inhibitor (FKBP-12) | Calcineurin inhibitor (Cyclophilin) |
| Relative potency | Higher at lower dose | Lower potency, higher dose |
| Tolerability | Improved burning profile | Significant burning sensation |
| Patient use | 4,000+ real-world (Italy) | Widely marketed |
Partnering for Registration and Market Access
ACS Biomed seeks pharmaceutical partners for clinical development, registration, and commercialization of ACRO-EYE™.
Clinical Development
Registration-grade clinical trials
Licensing
Formulation licensing or technology transfer
Market Introduction
National and international launch
IP Strategy
Patent evaluation and protection
For inquiries about co-development, licensing, or acquisition opportunities for ACRO-EYE®, contact our Business Development team.
Contact Business Development