POLYPHIL EYE (PHILART) (1x2ml)

Croma

Injectable biostimulator

Polynucleotide skinbooster for eye contour and periocular area

CE Marked Class III medical device (EU approved) for intradermal periocular use by healthcare professionals
Complies with CE marking standards and applicable EU medical device regulations for injectable medical devices
Intended exclusively for professional/strict medical use in aesthetic medicine settings

CE Marked Class III medical device (EU approved) for intradermal periocular use by healthcare professionals
Complies with CE marking standards and applicable EU medical device regulations for injectable medical devices
Intended exclusively for professional/strict medical use in aesthetic medicine settings

Polynucleotide skinbooster for eye contour and periocular area

Description

POLYPHIL EYE (PHILART) (1x2ml) is a polynucleotide-based injectable biostimulator from Croma’s PolyPhil/PhilArt range, designed specifically for the delicate periocular region (eye contour and eyelids). It contains PN-HPT® (Polynucleotides Highly Purified Technology) at 15 mg/2 ml to stimulate dermal regeneration, improve hydration, elasticity and skin quality, helping to soften fine lines, wrinkles and signs of tiredness around the eyes. The product is supplied as a sterile, intradermal Class III medical device for strict medical use by trained healthcare professionals only.

Bnefits

Targets the delicate eye contour and eyelids to rejuvenate the periocular area
Improves skin hydration, elasticity and overall skin quality around the eyes
Helps reduce the appearance of fine lines, superficial wrinkles and crepey skin
Revives tired-looking under-eyes and improves radiance and tone
Stimulates fibroblast activity and dermal cell regeneration via long-chain polynucleotides (PN-HPT®)
Provides a biostimulating, tissue-supporting effect rather than volumising like a traditional filler
Designed for both young and mature patients for prevention and correction of early ageing signs
Can be used as a priming treatment before other procedures (lasers, fillers, peels, RF, surgery) in the eye area

Indications

Eye contour (periorbital area)
Upper and lower eyelids
Tired-looking eyes and dull periocular skin
Superficial periocular fine lines and wrinkles (crow’s feet, fine periorbital rhytids)
Loss of elasticity and tone in the delicate eye area
Skin quality improvement in sensitive and thin periocular skin
Preventive anti-ageing treatment in young patients for the eye area
Supportive or priming treatment before other aesthetic procedures around the eyes

Composition

PN-HPT® polynucleotides (highly purified long-chain polynucleotides) 15 mg/2 ml
Physiological buffered solution (vehicle for intradermal injection; excipients as per manufacturer’s IFU)

Formulation

Sterile, injectable polynucleotide solution/gel for intradermal administration
Concentration: 15 mg PN-HPT® per 2 ml pre-filled syringe
Non-crosslinked biostimulating polynucleotides (not a hyaluronic acid filler)
Class III medical device for professional use only
Pyrogen-free, single-use, pre-filled syringe

Packaging

Box containing 1 pre-filled syringe x 2 ml of POLYPHIL EYE (PHILART)
Includes 2 x 30G 1/2 needles, length 13 mm, for intradermal injection
Single-patient, single-use presentation
Labelled as a Class III medical device for strict medical/professional use
Customs / tariff reference category often reported under HS code 30049000 (medicaments, etc.)

Usage

For intradermal injection only, in the periocular region (eye contour and eyelids), performed exclusively by trained and legally authorised healthcare professionals experienced in aesthetic injections.
Typical treatment areas include the periorbital skin, including under-eye region, crow’s feet area and, where appropriate, upper and lower eyelids, avoiding intra-vascular or intra-ocular injection.
Recommended injection depth: intradermal.
Recommended injection techniques (performed according to physician training and local guidelines): microdroplet, linear threading or fan technique using the supplied 30G 1/2 (13 mm) needles or equivalent devices approved by the practitioner.
Typical dose per session: approximately 1–2 ml per treatment session, adjusted according to the size of the treatment area, patient’s skin condition and professional judgment.
Suggested initial protocol: 3–4 treatment sessions spaced roughly 2–3 weeks apart.
Maintenance: follow-up or booster treatments can be considered every 6–12 months depending on individual clinical response and ageing profile.
Post-treatment recommendations generally include avoiding intense UV exposure, extreme temperatures, makeup on the treated area and vigorous rubbing for 24–48 hours; patients should follow the specific aftercare protocol given by their treating physician.
Do not use if the packaging is damaged, if the solution appears cloudy or contains particles, or after the expiration date.
Before use, inspect the syringe and verify batch number, expiry date and integrity of the sterile packaging; use aseptic technique throughout the procedure.

Contraindications

Known hypersensitivity or allergy to polynucleotides (PN-HPT®) or any other component of the formulation
Active skin infection, inflammation, dermatitis or lesions at or near the intended injection sites
History of severe allergies, anaphylactic reactions or hypersensitivity to injectable implants or similar products, in the treating physician’s judgement
Autoimmune diseases or immunodeficiency conditions where stimulation of tissue repair may be contraindicated, unless carefully evaluated and cleared by a specialist
Pregnancy and breastfeeding (use not recommended due to lack of safety data in these populations)
Known coagulation disorders or patients receiving anticoagulant/anti-platelet therapy where the risk of bleeding or bruising is considered unacceptable
Any severe systemic disease or uncontrolled chronic condition that, in the physician’s opinion, makes aesthetic injectable treatment inappropriate
Previous adverse reaction to other polynucleotide-based injectables if considered relevant by the treating practitioner

Adverse Effects

Common, usually transient reactions at the injection site: erythema (redness), swelling, oedema, tenderness, pain, pruritus (itching) and minor bruising or ecchymosis
Temporary irregularities or palpable small papules related to intradermal product placement, usually resolving spontaneously
Less common events: localized hematoma, increased sensitivity, or mild inflammatory reactions
Rare but more serious events reported with injectable procedures in general may include hypersensitivity reactions, infection, granuloma formation, vascular compromise/occlusion or other unexpected local or systemic reactions
Patients should be instructed to contact their practitioner promptly if they experience prolonged pain, significant swelling, changes in vision, signs of infection (such as increasing redness, warmth, pus or fever) or any other unexpected symptoms

Storage Conditions

Store in a clean, dry environment between 2°C and 25°C.
Protect from direct light and heat; keep the syringe in its original blister and outer packaging until use.
Do not freeze the product.
Do not use after the expiration date indicated on the packaging.
Keep out of reach of children and non-medical personnel.

Duration

Initial course typically consists of 3\u20134 intradermal treatment sessions spaced approximately 2\u20133 weeks apart, with maintenance sessions recommended every 6\u201312 months depending on the patient\u2019s response and skin ageing.

Onset

Improvement in skin quality and periocular appearance is often noticeable within about 30 days after treatment initiation, with optimal results building progressively over the full course of 3\u20134 sessions.