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✓ August 2025: Registered in the United States – FDA Cosmetic Framework (MoCRA)
BIOCHROMAEYES® Aesthetic is registered as a cosmetic product in accordance with the requirements of the Food and Drug Administration (FDA) under the Modernization of Cosmetics Regulation Act (MoCRA), marking a major milestone in BIOTIC Phocea’s international development.
Since August 2025, BIOCHROMAEYES® Aesthetic has been listed in the Food and Drug Administration (FDA) cosmetic product registration system.
This achievement is the culmination of several months of work carried out by the BIOTIC Phocea teams to meet the particularly demanding requirements of the U.S. market. Technical documentation, safety data, traceability, quality control, labeling, and vigilance procedures: every step required rigorous preparation to comply with the new requirements introduced by the Modernization of Cosmetics Regulation Act (MoCRA).
Far more than a regulatory formality, this registration represents a major strategic milestone, confirming BIOTIC Phocea’s ability to combine innovation, quality, and international regulatory compliance in support of ophthalmology and keratopigmentation professionals worldwide.
This initiative reflects BIOTIC Phocea’s commitment to providing keratopigmentation professionals with a solution developed within a controlled, documented, and compliant regulatory framework.
A Process Designed for Ophthalmology Professionals
BIOCHROMAEYES® Aesthetic is intended for professional use as part of procedures performed by practitioners trained in aesthetic keratopigmentation.
The range has been developed to meet high standards in formulation, traceability, safety of use, and documentation control, with an approach specifically adapted to the requirements of corneal application.
Manufactured within a robust quality system
BIOCHROMAEYES® Aesthetic products are manufactured within an environment operating under a quality management system compliant with ISO 13485 standards.
This organization ensures control over manufacturing, quality monitoring, traceability, and surveillance processes, providing rigorous oversight throughout the product lifecycle.
Traceability
Batch tracking, component documentation, and quality data retention.
Sterility
Sterile, single-use product manufactured using a documented sterilization process.
Safety
Toxicological and biological assessments conducted to document the product’s safety profile.
Compliance
Documentation structured in accordance with applicable U.S. market requirements under the MoCRA framework.
A Comprehensive Safety Assessment
The safety of a pigment intended for keratopigmentation requires a rigorous scientific evaluation of its composition, ingredients, and conditions of use.
As part of this process, BIOCHROMAEYES® Aesthetic formulations have undergone assessments focusing in particular on:
- chemical characterization;
- the toxicological profile of substances;
- sensitization potential;
- phototoxicity.
This approach helps document the product’s safety profile under normal and reasonably foreseeable professional conditions of use.
Regulatory Documentation Adapted to the U.S. Market
The BIOCHROMAEYES® Aesthetic compliance file brings together the information required to demonstrate the product’s safety, quality, and regulatory compliance.
- Formulation and ingredient information.
- Manufacturing process documentation.
- Traceability and stability records.
- Safety and toxicological assessment data.
- Labeling, precautions for use, and usage restrictions.
- Adverse event monitoring and vigilance procedures.
An International Vision Built on Compliance
Access to the U.S. market represents an important milestone in the international development of BIOCHROMAEYES® Aesthetic.
This regulatory initiative, conducted in accordance with applicable FDA requirements under the MoCRA framework, reflects BIOTIC Phocea’s commitment to responsible, structured, and well-documented innovation.
Through BIOCHROMAEYES® Aesthetic, BIOTIC Phocea continues its mission: supporting ophthalmology professionals with solutions developed according to high standards of quality, safety, and compliance.
BIOCHROMAEYES® Aesthetic: a rigorous regulatory approach designed to support keratopigmentation professionals within a secure, structured framework compliant with U.S. market requirements.
*As a cosmetic product registered under the MoCRA (Modernization of Cosmetics Regulation Act) framework.