PLINEST® Eye – 1 × 2ml

PLINEST® Eye – 1 × 2ml

PLINEST® Eye is a specialised PN-HPT™ Polynucleotide injectable skin-rejuvenation treatment developed by Mastelli specifically for the delicate periocular and eye-contour area.

Each 2ml pre-filled syringe contains 15mg of highly purified PN-HPT™ Polynucleotides, providing a concentration of 7.5mg/ml. This specialist formulation has been developed for the thin and sensitive tissues surrounding the eyes, where controlled intradermal treatment can support progressive improvement in skin quality without relying on the structural volumisation associated with conventional dermal fillers.

PLINEST® Eye is designed primarily to improve periocular skin quality, texture, firmness and elasticity. It is particularly suited to patients presenting with fine superficial wrinkles, reduced elasticity, crepey-looking skin and other visible signs of deterioration within the eye-contour area.

The product incorporates Mastelli's proprietary PN-HPT™ – Polynucleotides High Purification Technology. This technology produces highly purified Polynucleotides of natural origin for use within regenerative aesthetic medicine.

Polynucleotides are deoxyribonucleotide polymers consisting of purified DNA fractions. Within professional aesthetic medicine, they are used to support biological processes associated with fibroblast activity, extracellular-matrix quality and tissue regeneration.

Rather than physically filling or projecting the treated area, PLINEST® Eye is designed to improve the quality and biological condition of the existing periocular skin.

This makes PLINEST® Eye fundamentally different from a traditional Hyaluronic Acid tear-trough filler. Its primary objective is skin bioregeneration rather than structural volumisation.

Pack Contents

Each pack contains:

• 1 × 2ml pre-filled syringe of PLINEST® Eye
• 15mg PN-HPT™ Polynucleotides per syringe
• Polynucleotide concentration: 7.5mg/ml
• 2 × sterile 30G ½" needles
• Sterile, non-pyrogenic viscoelastic gel
• Professional medical-device packaging
• Product information and Instructions for Use
• Traceability information where supplied

Each syringe and supplied needle is intended for single use only.

Always check the individual product packaging and current Mastelli Instructions for Use before treatment.

Product Composition

PN-HPT™ Polynucleotides – 15mg / 2ml

PLINEST® Eye contains:

• 15mg PN-HPT™ per 2ml syringe
• Equivalent concentration: 7.5mg/ml

The formulation does not rely on Hyaluronic Acid for volumisation. Its principal component is Mastelli's highly purified PN-HPT™ Polynucleotide technology.

PN-HPT™ Polynucleotides are deoxyribonucleotide polymers consisting of highly purified DNA fractions.

Within aesthetic medicine, Polynucleotides are used to support biological processes involved in maintaining and improving skin quality.

Their regenerative activity is associated with support for:

• Fibroblast activity
• Collagen production
• Extracellular-matrix quality
• Skin elasticity
• Skin firmness
• Tissue regeneration
• Skin texture
• Overall skin quality

This regenerative approach allows PLINEST® Eye to address the condition and quality of the periocular skin rather than simply adding volume beneath it.

PN-HPT™ High Purification Technology

PLINEST® Eye incorporates Mastelli's proprietary PN-HPT™ – Polynucleotides High Purification Technology.

Mastelli is an Italian pharmaceutical company established in 1952 with extensive experience in the development and manufacture of Polynucleotide-based medical products.

PN-HPT™ is produced using Mastelli's specialised purification process to obtain highly purified Polynucleotides of natural and controlled origin.

The technology is designed to provide a high level of:

• Purity
• Quality
• Consistency
• Biocompatibility
• Suitability for professional medical use

The resulting Polynucleotide chains form a sterile viscoelastic gel suitable for controlled intradermal administration.

Mastelli's PN-HPT™ technology forms the basis of several products within the PLINEST® range, with different formulations developed for specific anatomical areas and skin requirements.

Specifically Developed for the Eye Contour

The periocular region presents unique treatment considerations because the skin surrounding the eyes is considerably thinner and more delicate than many other facial areas.

Visible ageing and deterioration within this region may present as:

• Fine superficial wrinkles
• Crow's feet
• Crepey-looking skin
• Reduced elasticity
• Reduced firmness
• Deterioration in skin texture
• Tired-looking periocular skin
• Reduced overall skin quality

PLINEST® Eye has therefore been formulated at a 7.5mg/ml PN-HPT™ concentration, providing 15mg within the complete 2ml syringe.

The formulation has been specifically developed to support regenerative treatment of delicate periocular tissues without relying on unnecessary structural volumisation.

Polynucleotide Bioregeneration

PLINEST® Eye works through a bioregenerative rather than volumising approach.

Following appropriate intradermal administration, PN-HPT™ interacts with the dermal environment and supports biological processes associated with skin regeneration and tissue quality.

Treatment is designed to support progressive improvement in:

• Fibroblast activity
• Collagen production
• Skin firmness
• Skin elasticity
• Skin texture
• Tissue quality
• Fine superficial wrinkles
• Overall periocular appearance

These changes develop progressively as the skin responds to treatment.

Unlike a conventional dermal filler, PLINEST® Eye is not primarily designed to create immediate projection or replace substantial lost facial volume.

The objective is instead to improve the quality, resilience and appearance of the existing periocular skin.

Key Benefits

• Specialist Polynucleotide treatment for the eye contour
• Contains 15mg PN-HPT™ per 2ml syringe
• PN-HPT™ concentration of 7.5mg/ml
• Uses Mastelli's proprietary PN-HPT™ High Purification Technology
• Specifically developed for delicate periocular skin
• Supports fibroblast activity
• Supports collagen production
• Promotes progressive skin bioregeneration
• Helps improve periocular skin texture
• Helps improve skin firmness
• Helps improve skin elasticity
• Helps reduce the appearance of fine superficial wrinkles
• Supports improvement in crepey-looking skin
• Helps improve overall eye-contour skin quality
• Provides progressive, natural-looking rejuvenation
• Does not rely on structural volumisation
• Sterile, non-pyrogenic viscoelastic gel
• Supplied in a 2ml pre-filled syringe
• Includes 2 × sterile 30G ½" needles
• Class III medical device
• Manufactured by Mastelli in Italy
• Intended strictly for appropriately qualified professional use

Common Treatment Areas

PLINEST® Eye has been specifically developed for the periocular region.

Depending on individual anatomy, professional assessment and the manufacturer's current Instructions for Use, treatment may include appropriate areas of the:

• Eye contour
• Lower periocular region
• Upper periocular region where professionally appropriate
• Lateral canthal or crow's-feet area
• Areas of fine superficial periocular wrinkling
• Areas of reduced periocular skin elasticity
• Areas demonstrating crepey or deteriorated skin texture

Treatment placement should always be determined according to individual anatomy, skin condition and professional assessment.

Understanding Under-Eye Concerns

PLINEST® Eye should not automatically be considered an appropriate treatment for every form of under-eye concern.

Dark circles and a tired-looking eye area can have multiple underlying causes, including:

• Pigmentation
• Vascular visibility
• Thin skin
• Structural shadowing
• Tear-trough anatomy
• Volume deficiency
• Oedema
• Lifestyle factors
• A combination of different causes

The underlying cause of the patient's concern should therefore be appropriately assessed before treatment.

Where poor skin quality, fine superficial wrinkling, crepey texture or reduced elasticity is a significant contributing factor, a specialist regenerative treatment such as PLINEST® Eye may be considered following professional assessment.

PLINEST® Eye vs Tear-Trough Dermal Filler

PLINEST® Eye should not be confused with a traditional Hyaluronic Acid tear-trough filler.

Traditional dermal fillers are primarily designed to:

• Replace lost volume
• Provide structural correction
• Alter contour
• Reduce anatomical depressions through physical filling

PLINEST® Eye instead focuses primarily on:

• Skin quality
• Skin texture
• Elasticity
• Firmness
• Fine superficial wrinkles
• Biological regeneration

It therefore provides a different treatment approach for patients whose principal concern relates to deterioration of the periocular skin itself rather than a structural volume deficiency requiring filler.

Different treatment modalities may be considered as part of a wider treatment plan where appropriate, but suitability should always be determined following comprehensive professional assessment.

PLINEST® Eye vs Standard PLINEST®

Although both products incorporate Mastelli's PN-HPT™ technology, they are formulated for different treatment requirements.

PLINEST® Eye

Contains:

• 15mg PN-HPT™ per 2ml
• 7.5mg/ml concentration

Specifically developed for:

• Eye contour
• Delicate periocular skin
• Fine superficial wrinkles
• Periocular skin texture
• Periocular firmness and elasticity

Standard PLINEST®

Standard PLINEST® uses a higher-concentration PN-HPT™ formulation intended for broader skin-rejuvenation applications.

The lower concentration of PLINEST® Eye reflects its specialised use within the thin and sensitive periocular tissues.

Practitioners should select the appropriate PLINEST® formulation according to anatomical area, skin condition, individual patient requirements and the manufacturer's current professional guidance.

Professional Treatment Protocol

Mastelli's published clinical material for PLINEST® Eye describes a treatment cycle of:

• 3 intradermal treatment sessions
• Approximately 2–3 weeks between sessions

A typical treatment pathway may therefore consist of:

• Treatment 1 – Baseline
• Treatment 2 – Approximately 2–3 weeks later
• Treatment 3 – A further 2–3 weeks later

The precise number and frequency of treatments should always be determined according to:

• Patient age
• Periocular skin condition
• Severity of skin deterioration
• Treatment objectives
• Previous aesthetic treatments
• Individual treatment response
• Current manufacturer guidance

Maintenance treatment may subsequently be considered following professional reassessment.

The treatment protocol should always follow the current Mastelli Instructions for Use and appropriate professional training.

Administration

PLINEST® Eye is designed for intradermal administration within appropriate periocular treatment areas.

Each pack includes 2 × sterile 30G ½" needles.

The precise administration technique, injection depth, product volume and distribution pattern should be determined according to Mastelli's current Instructions for Use, appropriate professional training and individual patient anatomy.

The periocular region requires particularly careful assessment and treatment because of its:

• Thin skin
• Complex vascular anatomy
• Delicate underlying tissues
• Tendency towards swelling
• Individual anatomical variation

Practitioners should possess suitable competence in periocular assessment and injectable treatment before administering PLINEST® Eye.

Clinical Evidence

PLINEST® Eye has been specifically evaluated for improvement of deteriorated periocular skin quality.

Mastelli's product-specific clinical material describes treatment using PN-HPT™ 15mg/2ml within the eye-contour area.

Reported clinical findings include improvements in:

• Periocular skin texture
• Skin tightening
• Fine superficial wrinkles
• Overall skin appearance

In one evaluation highlighted within Mastelli's product material, more than 90% of patients experienced clinical improvement in fine superficial wrinkles and skin appearance, with outcomes also assessed using objective three-dimensional skin analysis.

Published clinical research has also evaluated low-concentration 7.5mg/ml PN-HPT™ formulations within delicate periocular tissues.

These findings support the positioning of PLINEST® Eye as a specialist skin-quality and regenerative treatment for the eye-contour area.

Clinical-study results represent outcomes observed within evaluated populations and should not be interpreted as guaranteed individual treatment results.

Results & Treatment Outcomes

PLINEST® Eye is designed to produce progressive improvement in periocular skin quality rather than immediate artificial volume.

Potential treatment outcomes may include:

• Improved periocular skin texture
• Improved skin firmness
• Improved elasticity
• Smoother-looking eye-contour skin
• Reduction in the appearance of fine superficial wrinkles
• Improvement in crepey-looking skin
• Fresher-looking periocular skin
• Improved overall skin quality
• Natural-looking rejuvenation

Because Polynucleotide treatment works by supporting biological regenerative processes, improvements develop progressively rather than appearing solely as an immediate filling effect.

Individual results will vary according to factors including:

• Patient age
• Baseline skin condition
• Severity of periocular ageing
• Number of sessions completed
• Treatment technique
• Lifestyle
• Smoking
• UV exposure
• General skin health
• Individual biological response

Maintenance treatment may be considered following professional reassessment where appropriate.

Skin Priming & Combination Treatments

Mastelli also describes PN-HPT™ treatment within the concept of Skin Priming.

The principle of Skin Priming is to improve the biological quality of the skin and prepare it for appropriately selected aesthetic and anti-ageing procedures.

Mastelli identifies potential synergy between PN-HPT™ skin priming and professional treatments including:

• Laser treatments
• Radiofrequency
• Dermal fillers
• Chemical peeling
• Needling procedures
• Appropriate surgical procedures

Combination treatment should only be undertaken following professional assessment and with appropriate consideration of treatment timing, tissue recovery and individual patient requirements.

Storage & Handling

PLINEST® Eye should be stored and handled according to Mastelli's current Instructions for Use.

To maintain product sterility and integrity:

• Keep within the original packaging until use
• Maintain appropriate storage conditions
• Protect from inappropriate environmental exposure
• Do not use if the sterile packaging has been damaged
• Do not use if the syringe appears damaged
• Do not use after the stated expiry date
• Do not use if product integrity is in doubt
• Maintain strict aseptic technique during treatment

Each syringe and supplied needle is intended for single use only.

Any remaining product should be managed and disposed of according to the manufacturer's instructions and applicable clinical-waste procedures.

Important Information

PLINEST® Eye is a Class III medical device for intradermal administration and is intended strictly for use by appropriately qualified healthcare professionals.

Appropriate professional knowledge of the following is essential:

• Periocular anatomy
• Facial vascular anatomy
• Intradermal injection techniques
• Polynucleotide treatments
• Patient selection
• Aseptic practice
• Periocular assessment
• Complication recognition and management

Before administration, practitioners should undertake:

• Comprehensive patient consultation
• Full medical history
• Detailed periocular assessment
• Assessment of skin quality
• Assessment of the underlying cause of the patient's concern
• Review of previous periocular injectable treatments
• Assessment for oedema or other factors affecting suitability
• Assessment of contraindications
• Discussion of realistic treatment expectations
• Explanation of potential treatment reactions
• Appropriate informed consent

Temporary treatment-site responses following intradermal administration may include:

• Redness
• Swelling
• Bruising
• Tenderness
• Mild discomfort
• Temporary papules or raised injection points
• Localised sensitivity

Because the periocular region is particularly delicate, practitioners should possess appropriate training in the prevention, recognition and management of complications.

PLINEST® Eye is intended to improve periocular skin quality and should not be presented as a structural replacement for tear-trough filler or as a guaranteed treatment for all causes of dark circles, eye bags or under-eye hollowing.

Practitioners should always consult the current Mastelli PLINEST® Eye Instructions for Use for complete indications, contraindications, precautions, warnings, administration guidance and potential adverse events before treatment.

Do not use if:

• The sterile packaging is damaged or compromised
• The syringe appears damaged
• The product has passed its expiry date
• Product integrity is in doubt
• Product authenticity cannot be verified

Each syringe and supplied needle is intended for single use only.

For professional use only.