Mydriasert Product Presentation

Indicated for pre- operative or diagnostic purposes when monotherapy is known to be insufficient

mydriasis in only one step

150-year heritage in Ophthalmology

• Working in Ophthalmology since 1865

• At the forefront of innovation - novel delivery systems, medicines etc.

• Leaders in Preservative Free eyecare • Dedicated to supporting education and training

mydriasis in only one step

insert

A UNIQUE MYDRIATIC INSERT

CONTAINING TWO MYDRIATICS

Preservative-free pellet

- Insoluble

- Ethylcellulose membrane for controlled release +

Lachrimal flow releases active substances

5.4MG

0.28MG

A UNIQUE MYDRIATIC INSERT

PROVIDING A WIDE AND STABLE MYDRIASIS1

BENEFITS OF

One-step mydriasis

Saves nurses’ time as no repeated administration of drops needed

Reduce patient to staff contact2

One-step mydriasis to enable staggered arrival times

Reduced use of hooks and rings associated delays and costs2

Large dilation may suit training lists

AWIDEANDSTABLE MYDRIASIS

Reduced use of iris hooks and rings and associated delays and costs2

Large dilation may suit training lists

Allows management of emergencies and unforeseen events

AGREATERMYDRIASIS

COMPAREDTOEYEDROPS

• Mydriasert produced a significantly wider dilation compared to mydriatic drops after 60 minutes3

• The number of Iris hooks ordered was 63% lower when using Mydriasert (p=0.03)2

Adapted from reference 4

EFFECTIVEWITHLESSACTIVE INGREDIENTSVSEYEDROPS

• After 2 hours, Mydriasert releases less than 40% of the dose contained in the insert1

• Plasma levels of phenylephrine measured over 6 hours in healthy volunteers were not detectable (<0.5 ng/ml)

EXCELLENT LOCALTOLERANCE

96% Of patients reported a normal appearance of the conjunctival fornix after dilation by insert

• Preservative–free formulation contained in a biocompatible insert for maximum patient comfort

• Eyes dilated with Mydriasert showed less ocular redness over time (p=0.024)3

• Faster recovery of near vision after dilation compared to drops7

STREAMLINING THE PUPIL DILATION PROCESS

ONE - STEP PREOPERATIVE MYDRIASIS

One-Step Preoperative Mydriasis Saves nurses’ time as no repeated administration of drops needed

ONE STEP vs. multiple instillations of mydriatic drops

Reduces patient to staff contact2

Allows for staggered arrival times

In line with ‘Restarting & Redesigning of Cataract Pathways’

2020 recommendations8

THE INSERT SHOULD BE REMOVED

Before the examination or surgical intervention:

• With a sterile compress

• With a sterile irrigation or washing solution

Provide clinical information required for a Drugs and Therapeutic application

How do Théa support YOU?

Support the product training of Nurses and Theatre Staff in the use of Mydriasert

Train a “super user” to train new Mydriasert users

Provide audit forms to support a Mydriasert evaluation

Be present during a theatre list when Mydriasert is first being used

NHS price = £84.00 for 1 x box of 20 inserts and 20 forceps

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard.

Adverse events should also be reported to Thea Pharmaceuticals Ltd. 0345 521 1290

References:

1. Mydriasert Summary of Product Characteristics

2. Shah, A. et al. BMC Ophthalmology (2015) 15:56

3. Gurpreet, K. et al. IOVS June 2017; Vol.58, no.8: 4336.

4. Levet, L. et al. J Fr Ophtalmol (2004) 27 (10): 1099 –1108.

5. Minims Phenylephrine Hydrochloride 10%, SPC, considering a drop is 50 μL.

Thea Pharmaceuticals Limited

IC5 Innovation Way . Keele University Science and Innovation Park . Keele

Newcastle Under Lyme . ST5 5NT

Head Office: 0345 521 1290 .

Medical Information: 0345 521 1290

6. Minims Tropicamide 0.5%, SPC, considering a drop is 50 μL

7. Torron, C. et al. Biomed Res Int (2013) EPub DOI: 10.1155/2013/849349.

8. Ophthalmic Services Guidance (Aug 2020) Restarting and Redesigning of Cataract Pathways in response to the COVID 19 pandemic. RCOphth

Mydriasert® 0.28 mg/5.4 mg ophthalmic insert (tropicamide/phenylephrine hydrochloride).

Abbreviated Prescribing Information: Please refer to Summary of Product Characteristics before prescribing. Contains: 0.28 mg of tropicamide and 5.4 mg of phenylephrine hydrochloride.

Main Indications, Dosage and Administration: For pre-operative mydriasis or for diagnostic purposes when monotherapy is insufficient. For use by health-care professionals only. One ophthalmic insert per operated eye, a maximum of 2 hours before surgery. Children: Contraindicated in children younger than 12 years and not recommended in children aged 1218. Do not leave the ophthalmic insert for more than two hours in the lower conjunctival sac. Remove the insert as soon as mydriasis is sufficient, and at the latest within the next 30 minutes. Manipulate aseptically. Avoid excessive manipulation of eyelids. Remove the ophthalmic insert from the lower conjunctival sac by using either sterile surgical forceps, a sterile swab or a sterile irrigation or washing solution, by lowering the lower eyelid. Do not reuse the insert. Discard the insert after use immediately.

Contraindications: Hypersensitivity to the active substances or any of the excipients. Risk of angle-closure glaucoma: in patients with closed angle glaucoma (unless previously treated with iridectomy) and patients with narrow angle prone to glaucoma precipitated by mydriatics. Children aged below 12 years.

Precautions and Warnings: Mydriasert causes long lasting visual disturbances, therefore the patient should be accompanied when attending the consultation. Protect the eye against bright light. Ocular hyperemia can increase absorption of the active ingredients in the insert. Shifting or, rarely, expulsion of the insert is possible; do not re use the removed insert, take a new one. Do not leave in the conjunctival sac for more than 2 hours. Take care with patients suffering from severe dry eyes, some patients may need a drop of saline solution to improve insert tolerance. All mydriatic agents may trigger an acute attack of glaucoma. Although negligible systemic passage of active ingredients occurs, phenylephrine has sympathomimetic activity that might affect patients with hypertension, cardiac disorders, hyperthyroidism, atherosclerosis or prostate disorders and in those contraindicated to systemic pressor amines.

Phenylephrine may produce positive results to tests for prohibited substances in sportsmen and athletes. Do not wear soft hydrophilic contact lenses during treatment. After the insertion of Mydriasert, and if the administration of other mydriatic agents cannot be avoided, take account of the doses in the insert. Cardiovascular derangement with severe hypertension, heart rate alterations and pulmonary oedema have been reported, particularly in paediatrics. Children below 12 years appear more sensitive than adults. Adequate clinical experience is missing in children between 12 and 18 years. Mydriasert causes disabling mydriasis for several hours, consequently, patients should not drive, use machines or perform other hazardous activities while visual disturbances persist.

Pregnancy and lactation: Do not use during pregnancy, unless necessary, or during breast feeding.

Undesirable Effects: Nervous system disorders. Very rarely: convulsions. Eye disorders. Commonly: stinging, blurred vision, visual discomfort. Uncommonly: tearing, irritation, disabling mydriasis, photophobia, superficial punctuate keratitis. Rarely: blepharitis, conjunctivitis, risk of angle-closure glaucoma, intraocular hypertension. Very rarely: corneal ulcer and corneal oedema due to forgotten insert. Topical mydriatic agents may cause the systemic effects: elevation of blood pressure, tachycardia, tremor, pallor, headaches, dry mouth, very rarely, major accidents such as cardiac arrhythmia. In children: Eye disorders, frequency unknown: periorbital pallor in preterm babies. Thoracic disorder, frequency unknown: pulmonary oedema.

Legal Category: POM.

PL Number: PL 20162/0011

Basic NHS Price: £84 for a box of 20 inserts

Marketing Authorisation Holder: LABORATOIRES THEA, 12 RUE LOUIS BLERIOT, 63017 CLERMONT-FERRAND CEDEX 2, France.

Date of Revision: 26/11/2021