ACRO-EYE™
Tacrolimus-Based Ophthalmic Solution for Keratoconjunctivitis Sicca
What is ACRO-EYE?
ACRO-EYE is a Tacrolimus-based ophthalmic formulation designed to treat keratoconjunctivitis sicca (dry eye syndrome) and other inflammatory conditions of the ocular surface.
Our proprietary galenic formulation eliminates the burning sensation and irritation that cause poor patient compliance with traditional formulations.
Tacrolimus is 10-30x more potent than Cyclosporine A (Restasis/Ikervis) and works by selectively blocking T-cell activation at the ocular surface, restoring natural tear production.
Who is it for
Patients with moderate-to-severe dry eye syndrome, Sjogren's disease, keratoconjunctivitis sicca and other inflammatory conditions of the ocular surface.
The problem it solves
Chronic autoimmune inflammation that destroys tear-producing glands, causing permanent discomfort and vision problems
Key Differentiator: ALCOHOL-FREE
First Tacrolimus formulation without alcohol = no burning = better compliance
ACRO-EYE Does NOT Contain ALCOHOL
Why this matters for clinical outcomes
The Problem with Traditional Formulations
Traditional Tacrolimus eye drops use alcohol as a solvent. When applied to an already inflamed and damaged ocular surface, alcohol causes intense burning and irritation. This leads to poor patient compliance - patients simply stop using the medication because the pain is unbearable.
ACRO-EYE Solution
Our proprietary galenic formulation completely eliminates alcohol while maintaining Tacrolimus stability and efficacy. Patients experience minimal or no irritation, leading to better adherence and ultimately better clinical outcomes. This is why ACRO-EYE is the preferred choice for both pediatric and adult patients.
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