POLYPHIL EYE (PHILART) (1x2ml)
Croma
Injectable biostimulatorPolynucleotide skinbooster for eye contour and periocular area
Certifications
- 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.
