How to deliver sterile eye drops

with a safer alternative to

preservatives?

CPhI 2017 – Faustine MUÑOZ

October 24th 2017

This document is the property of NEMERA and must not be copied, reproduced, duplicated nor disclosed totally or partially to any Third Party,

nor used in any manner whatsoever without the prior written consent of NEMERA © NEMERA 2014

Agenda

01

02

03 Case study on the PFMD eye dropper solution: Novelia®

Multidose eye droppers market & trend to PFMD

Patients’ needs and expectations

Multidose eye droppers market& trend to PFMD01

| 4

50% of Patients suffer from

preservatives side-effects

main players = 41%

MD eye dropper

market

(Novartis, Allergan, Santen)

RED EYES

Most common

preservative:

Benzalkonium

Chloride (BZK or BKC or BAC)

ALLERGIES ITCHINESS

All Key Opinion Leaders agree on

the danger of preservatives

“Communication on preservatives is

no longer needed; all necessary

studies have already been made

to prove the negative impact of

preservatives to the eye.”

Pr Florent Aptel, professor in

Ophthalmology at Grenoble CHRU,

Director of France Glaucoma

Association

| 5

Global MD eye dropper market driven up

by PFMD faster growth in all regions

MD eye dropper market size in 2020 (in units)

with 2.7% CAGR

PFMD: Preservative Free

Multidose

COMPLIANCEMULTIDOSE

EYE DROPPER

COMPLIANCE

MULTIDOSE

EYE DROPPERS

PRESERVATIVE

FREE

MULTIDOSE

EYE DROPPERS PFMD market CAGR until 2020

MD: Multidose

CAGR: Compound Annual Growth

Rate

PFMD sales in 2016

PFMD sales in 2020

IMPRESSIVE

GROWTH OF

PFMD

GLOBALLY

Patients’ needsand expectations02

| 7

Listening to Patients is key…

Listening to Patient feedback is key

to build and execute user assessments

(User interface, Patient adherence, Misuse cases…)

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…and also Patient integration

in Device development

Co-create concepts

User needs andexpectations

Focus group

Product verificationand validation

Design selection

Product testing

| 9

Key findings

on Patients’ needs in Ophthalmics…

COMPLIANCECOMPLIANCENo side effects

(due to contamination)

COMPLIANCESAFETY

CONVENIENCE

No risk of contamination

• Hygiene of the bottle when dispensing

the drop

• Hermetic closing

(also during transportation)

• Flow control

• Drop dispensing until the last drop

• Eye targeting

• Easy to use with an intuitive handling

• Adapted to mobile use

…as first

foundations

to design

Novelia®

PFMD

eye dropper

Case study on the PFMD eye dropper solution: Novelia®03

| 11

The PFMD eye dropper solution: Novelia®

Novelia® avoids the need for preservatives in the drug and

prevent bacterial contamination over treatment duration

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The PFMD eye dropper solution: Novelia®

PREVENT

…a continuous drug flow &

drop delivery

…with no bacterial

contamination

CONTROL

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Novelia® functioning in 5 steps

5

Remaining drop

protection Silver ions embedded in

the Cap protect remaining

drop

(no contamination of any

liquid remaining on the tip)

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Selecting design options

Solutions

Functions

Device PFMD Dropper

Drop Protection

Protection from

contamination

Hermetic closing system

Decontamination by contact, no

leaching in container

Drying

Simple but risk of contamination

(until drop is entirely dry + spore-forming strains when

dry)

Absorption

Good solution for sticky

formulations

Important to avoid contact between tip

and absorber

Air Intake

Filter

Impossible to guarantee

100% integrity in

mass production

PureFlow

100% controlled

No living organism can grow through or cross the

barrier

Novelia® Novelia®

Vented Cap

All Novelia®

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Detailed functioning – valve reclosing

(step 3)

Valve recloses sealing the packaging system tight

• The one-way valve closes preventing liquid from being sucked back into the bulk,

thus preventing any retro-contamination by liquid backflow.

• The action of closing the one-way valve breaks the liquid column between the nozzle and

the bulk.

No liquid backflow

0% risk of contamination

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Detailed functioning – Air compensation

(step 4)

PureFlow® technology :

an alternative solution to filters for a MAXIMUM SAFETY

By using the air permeation property of

the silicone PureFlow® technology

allows air to diffuse into the bottle and

prevent any germ/contamination to

enter the bottle. Solid, non porous material

Homogenous, no hole

Intermolecular distance

in nanometers 100% of the air entering the

bottle is PURE

0% risk of contamination

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Filtration technology is NOT used

in Novelia®

• Filtration technology is NOT used in Novelia®

• Disadvantages of filter technology:

• Filter with pore size <0.22micron does not provide a continuous

barrier through product life. Bacteria can pass through 0.2micron

• Sterilizing filter cannot be verified by 100% on-line integrity testing

(Testing method introduces bacteria and liquid onto the surface of the filter.

This starts bacterial growth on the filter and therefore decreases the

subsequent shelf life of the dispenser. Therefore in-line testing of MD eye

droppers that rely on filter is not possible)

• Sterilizing filters fail if wetted

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One drop at a time

into the Patient’s eye

• PureFlow® Technology is used for air filtration and also for flow control

Several flow controls for each type of viscosities

One drop at a time

into the patient’s eye

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Detailed functioning – Remaining drop protection

Step 5

• Some residual liquid (20% of a nominal drop size) can remain on the outside of the tip

as the liquid is prevented from returning into the container by the one-way valve.

• The liquid remaining is protected from bacterial growth by the presence of silver ions in the

outer components (Top and Cap).

The remaining drop is further protected by the cap reclosing.

This does not influence the shelf life, as even without the cap reclosing, the remaining liquid

dries, minimising the likelihood of bacterial growth.

• Silver ions are only in contact with the remaining drop which is prevented from returning

to the bottle by the non-return valve, not with the drug. Silver ions act by contact.

With

the remaining drop

0% risk of

contamination

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Easy to target the eye

and Novelia® intuitive handling

Blue tip for a better precision

when targeting the eye… …with an intuitive & user friendly

device as easy to use as any standard

eye dropper

Blue tip

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Novelia®

a PFMD device designed to meet Patients’ needs

When drop

deliverance

No

side effects

No

contaminated

remaining

drop

Hermetic

closing

Easy targeting Adapted to

mobile use

Easy to use &

Intuitive

handling

SAFETY: NO RISK OF CONTAMINATION

CONVENIENCE

COMPLIANCE

Flow

control

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Thank you for your attention !

• On our booth:

Hall 4.2 – Stand 42D40

• During the Innovation Tour:

Liquid formulation devices

on Thursday 26th October

You are most welcome to discover Novelia®!

www.nemera.net

information@nemera.net