KEMIN PHARMA - polytech-online · Marigold, processed by Kemin with high quality standards Primarily used as a natural colorant due to its orange--red color Lutein and zeaxanthin

KEMIN PHARMA

Kemin Industries & Kemin Pharma

Kemin Pharma’s Research

Kemin Pharma’s Portfolio

Phacodyne

Doubledyne

Retidyne

Tripledyne

RetidynePlus

Vitreodyne

Portfolio Table

Strong Scientific Evidence

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Kemin Pharma is committed to provide medical devices that meet or exceed our customers’ expectations of quality, safety, effectiveness and reliability. Our medical devices demonstrate high quality performance and utilize superior technology. We strive for continual improvement in all aspects of our medical devices. We are committed to comply with all regulatory requirements and to maintain a robust quality management system.

COMMITMENT TO QUALITY

Patent submission for the first lutein-based dyes used for cataract

and retinal surgery.

P P

4 NEW INVENTION DISCLOSURES

1 NEW PATENTsubmitted in the last

quarter of 2014

Employees hold, at least, a Master’s Degree

CONTINUOUS MEDICAL SUPPORT

15 Technical Literatures released in only 2 Years

Solid scientific foundations with 8 scientific papers on Kemin Pharma’s products published in peer-reviewed journals with high impact in Ophthalmology.1-8

Expanding to new countries in Europe, Middle East,

APAC and America.

COUNTRIES

Business operationsin more than

MANUFACTURING PLANTS spread across the globe

KEMIN INDUSTRIESGlobal Company founded in 1961

KEMIN PHARMA

The most recent of the 6 business divisions.

Created in 2013.

Products distributed and sold to

KEMIN PHARMA INFOGRAPHICS

COUNTRIES WORLDWIDE

mAU

UV B UV A2 UV A1

200

150

100

50

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300 350 400 450 500 550 nm

VISIBLE LIGHT

Amax= 446 nm

InfraredUltraviolet

KEMIN PHARMA’S ROBUST RESEARCH ON LUTEIN

Traditionally found in fruits and

dark-green leafy vegetables

Extracted from Marigold, processed by Kemin with high quality standards

Primarily used as a natural colorant due to its orange--red color

Lutein and zeaxanthin are

registered in Brazil, Europe and the US

as natural dyes

Due to their exclusive distribution in the lens and in the macula lutea lutein and zeaxanthin are believed to play a protective role in these tissues and to prevent several maculopathies.

Potential photoprotection against light from endoilluminators

Potential protection against free radicals during the surgery*

Blue-light filtering

properties 9

Antioxidant effect

10-11

L U T E I N

*Lutein is thought to scavenge ROS generated during inflammatory process and to interfere inintracellular pathways leading to the expression of various pro-inflammatory molecules.12,13

Lutein absorbs blue light at wavelengths around 450 nm with a peak of absorption at 446 nm.11

Pre-

clin

ical

Clin

ical

Efficacy in Cadaveric Eyes1

Efficacy of a lutein-based dye (PhacodyneTM) for visualizing anterior capsulorhexis during cataract surgery by phacoemulsification6

Comparative clinical study [safety profile of crystalline lutein]

2012

Intravitreous Toxicity in Rabbits2

Cytotoxicity in Cell Line Model3

MoA4

Comparative cytotoxicity study

Photoprotection study in vitro

Comparative MoA5

Lutein distribution in eye structuresex-vivo

Soluble lutein in combination with brilliant blue as a new dye for chromovitrectomy7

Lutein: A New Dye for Chromovitrectomy 8

Efficacy and excellent safety profile

2016

+

COMPARATIVE MECHANISM OF ACTION 5

Lutein

Retinal Membrane Model

SyntheticDyes

Retinal Membrane Model

Efficacy — Ideal color for structures visualization.6-8

High density — Falling by gravity, Selective posterior pole deposition.7 Innovative lutein-based dye with proven physical MoA and excellent safety profile.4-5

Following the rational and benefits of Lutein in the Human Eye, KEMIN Pharma developed a full range of Lutein based intraocular dyes, containing Lutein alone or using Lutein in combination with the “gold standard” synthetic dyes.

LUTEIN BASED INTRAOCULAR DYES

Lutein-based dyes interact through non-chemical bonding with surrogate intraocular membrane models without altering their molecular structure.

Create space inside the syringe by pushing its plunger back.

Shake Vigorously for 5 seconds immediately prior to injection.

Pull and push the plunger to facilitateits movement.

Efficacious alternative to products containing higher levels of synthetic dyes.

Phacodyne is an intraocular dye intended for use in cataract surgery to assist in capsulorhexis.

Phacodyne contains: Soluble lutein (1%); Trypan blue (0.04%); Inactive biologically compatible vehicle.

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Anterior Segment | Cataract Surgery | Soluble Lutein

AnteriorCapsule

x5 x10

PORTFOLIO

Allows the entire anterior lens capsule visualization in the absence of red reflex.

Anterior Capsule staining for cataract surgeries.

Intense green color optimal for staining contrast.

Double staining lutein-based heavy dye.Allows a quicker and less complex surgery.

Doubledyne is an intraocular dye intended for use in vitreoretinal surgery to facilitate the staining of the internal limiting membrane and/or epiretinal membrane.

Doubledyne contains: Soluble lutein (2%); Brilliant blue (0.05%); Trypan blue (0.15%); Inactive biologically compatible vehicle.

Posterior Segment | Vitreoretinal Surgery | Soluble Lutein

ERM

ILM

ERM

Create space inside the syringe by pushing its plunger back.

Shake Vigorously for 5 seconds immediately prior to injection.

Pull and push the plunger to facilitateits movement.

HO

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x5 x10

PORTFOLIO

High density provides a cohesive sinking8 and subsequent easier aspiration.

Simultaneous ILM & ERM stainingfor additional contrast.

Selective posterior pole deposition eliminates the need for vigorous dye flushing or fluid-air exchange.7-8

Posterior Segment | Vitreoretinal Surgery | Soluble Lutein

Efficacious and cost-effective solution for ILM staining.

Retidyne is an intraocular dye intended for use in vitreoretinal surgery to facilitate the internal limiting membrane staining.

Retidyne contains: Soluble lutein (2%); Brilliant blue (0.05%); Inactive biologically compatible vehicle.

ILM

Create space inside the syringe by pushing its plunger back.

Shake Vigorously for 5 seconds immediately prior to injection.

Pull and push the plunger to facilitateits movement.

HO

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PORTFOLIO

x5 x10

High density provides a cohesive sinking8 and subsequent easier aspiration.

Intense green color optimal for staining contrast.

Selective posterior pole deposition eliminates the need for vigorous dye flushing or fluid-air exchange.7-8

Unique product, multiple targets.Diversified contrast due to innovative formulation.Allows a quicker and less complex surgery.

Tripledyne is an intraocular dye intended for use in vitreoretinal surgery to facilitate triple staining of the vitreous, the internal limiting membrane and epiretinal membrane.

Tripledyne contains: Crystalline lutein (1.8%); Brilliant blue (0.05%); Trypan blue (0.15%); Inactive biologically compatible vehicle.

Posterior Segment | Vitreoretinal Surgery | Crystalline Lutein

Aspire up to 1 ml of liquid into the syringe.

Apply slowly and in a circular way directly to the vitreous.

Shake Vigorously for 5 seconds immediately prior to injection.

ILMVitreous

ERM

PORTFOLIO

x10

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High density provides a cohesive sinking8 and subsequent easier aspiration.

Innovative triple staining.

Selective posterior pole deposition eliminates the need for vigorous dye flushing or fluid-air exchange.7-8

Excellent Vitreous visualization due to Lutein crystals.

Vitreous & ILM staining in one injection.Allows a quicker and less complex surgery.

Retidyne Plus is an intraocular dye intended for use in vitreoretinal surgery to facilitate dual staining of the vitreous and the internal limiting membrane.

Retidyne Plus contains: Crystalline lutein (1.8%); Brilliant blue (0.05%); Inactive biologically compatible vehicle.

Posterior Segment | Vitreoretinal Surgery | Crystalline Lutein

ILMVitreous

PORTFOLIO

x10

Aspire up to 1 ml of liquid into the syringe.

Apply slowly and in a circular way directly to the vitreous.

Shake Vigorously for 5 seconds immediately prior to injection.

HO

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High density provides a cohesive sinking8 and subsequent easier aspiration.

Convenient simultaneous Vitreous & ILM staining.

Selective posterior pole deposition eliminates the need for vigorous dye flushing or fluid-air exchange.7-8

Excellent Vitreous visualization due to Lutein crystals.

Staining by Crystalline lutein only.Intense orange color allows a clear visualization of the Vitreous for top performance vitrectomies.

Vitreodyne is an intraocular dye intended for use in vitreoretinal surgery to facilitate the vitreous staining.

Vitreodyne contains: Crystalline lutein (2%); Inactive biologically compatible vehicle.

Posterior Segment | Vitreoretinal Surgery | Crystalline Lutein

Vitreous

PORTFOLIO

x10

Aspire up to 1 ml of liquid into the syringe.

Apply slowly and in a circular way directly to the vitreous.

Shake Vigorously for 5 seconds immediately prior to injection.

HO

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High tropism for vitreous provides a powerful dispersion for complete vitreous outermost periphery removal.

Precise visualization and identification of the vitreous.

High density eliminates the need for vigorous dye flushing or fluid-air exchange during vitrectomies.7-8

No biological or pharmacological effect.

KEMIN PHARMA PORTFOLIO

Presentation

Color

Composition

Lutein %

PHACODYNE

Dark Green

Soluble Lutein +TB

1%

RETIDYNE

Green

Soluble Lutein +

BB

2%

RETIDYNECAP

Green

Soluble Lutein+

BB

1%

Greenish Blue

Soluble Lutein+ BB+ TB

2%

DOUBLEDYNE

Orange

Crystalline Lutein

2%

VITREODYNE RETIDYNE PLUS

Greenish blue

Crystalline Lutein

+BB

1,8%

Dark Greenish Blue

1,8%

CrystallineLutein+ BB+ TB

TRIPLEDYNE

STAI

NING

AC

ILM

ERM

Vitreous

Lutein Soluble Crystalline

Surgery Cataract Vitreoretinal

1ml vial 0,5ml syringe 1ml vial

ALL KEMIN PHARMA PRODUCTS HAVE CE MARK.

Lutein possesses an isomer called zeaxanthin, which is also present in the formulation.

1. Diogo Sousa-Martins, Maurício Maia, Milton Moraes, et al. Use Of Lutein And Zeaxanthin Alone Or Combined With Brilliant Blue To Identify Intraocular Structures Intraoperatively. Retina 2012;32(7):1328-1336. 2. Furlani B, Barroso L, Sousa-Martins D, et al. Lutein and Zeaxanthin Toxicity With and Without Brilliant Blue in Rabbits. J Ocul Pharmacol Ther. 2014 Sep;30(7):559-66. 3. Casaroli-Marano RP, Sousa-Martins D, et al. Dye solutions based on lutein and zeaxanthin: in vitro and in vivo analysis of ocular toxicity profiles. Current Eye Research. 2015;40(7):707-18 4. Caseli L, Sousa-Martins D, Maia M, Lima-Filho AA, Rodrigues EB, Belfort R Jr. An intraocular dye solution based on lutein and zeaxanthin in a surrogate internal limiting membrane model: a Langmuir monolayer study. Colloids Surf B Biointerfaces 2013;107:124-129. 5. Sousa-Martins D, Caseli L, Figueiredo MC, et al. Comparing the mode of action of intraocular lutein-based dyes with synthetic dyes. Invest Ophthalmol Vis Sci. 2015; 56(3):1993-2000. 6. Vianna LM, Cohen MJ, Muccioli C, Lima A, Sousa-Martins D, Maia M, Belfort Jr R. Efficacy and safety of a lutein-based dye (Phacodyne™) for visualizing anterior capsulorrhexis during cataract surgery by phacoemulsification. Arq Bras Oftalmol 2014; 77(3):173-177. 7. Badaró E, Furlani B, Prazeres J, et al. Soluble lutein in combination with brilliant blue as a new dye for chromovitrectomy. Graefes Arch Clin Exp Ophthalmol 2014; 252: 1071–1078.

8. Maia M, Furlani BA, Souza-Lima AA, Martins DS, Navarro RM, Belfort R Jr. Lutein: A New Dye for Chromovitrectomy. Retina 2014; 34: 262–272. 9. Junghans A, Sies H and Stahl W. Macular Pigments Lutein and Zeaxanthin as Blue Light Filters Studied in Liposomes. Archives of Biochemistry and Biophysics 2001; 391(2): 160-164. 10. Bian Q, Gao S, Jilin Z, et al. Lutein and zeaxanthin supplementation reduces hotooxidative damage and modulates the expression of inflammation-related genes in retinal pigment epithelial cells. Free Radical Biology and Medicine 2012; 53(6): 1298-1307. 11. Sundelin SP, Nilsson SE. Lipofuscin-formation in retinal pigment epithelial cells is reduced by antioxidants. Free Radical Biology & Medicine 2001; 31(2): 217-225. 12. Kijlstra A, Yuan T, Kelly ER, et al. Lutein: More than just a filter for blue light. Progress in Retinal and Eye Research 2012; 31(4):303-315. 13. Kim JH, Na HJ, Kim CK, et al. The non-provitamin A carotenoid, lutein, inhibits NF-appa B-dependent gene expression through redoz-based regulation of the hosphatidylinositol 3-kinase/PTEN/Akt and NF-kappa B-inducing kinase pathways: role of H2O2 in NF-kappa B activation. Free Radical Biology and Medicine 2008; 45(6): 885-896.

STRONG SCIENTIFIC EVIDENCE

REFERENCES

Not all products are available in all areas. Product labeling and associated claims may differ based on regulatory requirements.

KEMIN PHARMARua das Ferrarias del Rei 6, 2730-269 Barcarena — [email protected] | www.kemin.com

Get to know more about our portfolio at:kemin.com/humans/pharmaceuticals

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KEMIN PHARMARua das Ferrarias del Rei 6, 2730-269 Barcarena — [email protected] | www.kemin.com