PROGRESSES IN MANAGEMENT IN OCULAR SURFACE AND SURGERY SUNDAY, SEPTEMBER 15th 2019

Chaired by Prof. Christina GRUPCHEVA

Laboratoires Théa Satellite Symposium

37TH CONGRESS OF THE ESCRS

PAVILLON 7, PARIS EXPO PORTE DE VERSAILLES 14 - 18 SEPTEMBER 2019

PARIS Visit our booth #ESCRS2019 PROGRESSES IN MANAGEMENT IN OCULAR SURFACE AND Chaired by Prof. Christina GRUPCHEVA

CHAIRPERSON’S INTRODUCTION Professor Christina GRUPCHEVA - Bulgaria

FROM ARTIFICIAL TEARS TO TARGETED EYE DROPS Professor Christina GRUPCHEVA - Bulgaria

DECODING IN DRY : NEW ADVANCES IN PATIENT MANAGEMENT Professor Gerhard GARHÖFER – Austria

TO STREAMLINE THE FLOW OF YOUR CATARACT SURGERY LIST Professor Rudy NUIJTS - The Netherlands

KEEP OCULAR SURFACE HEALTHY IN CATARACT SURGERY Professor Jose GÜELL – Spain / Dr Spyridoula Souki, MD, FEBO – Spain

CHAIRPERSON’S CONCLUSION Professor Christina GRUPCHEVA - Bulgaria

3 - PROGRESSES IN MANAGEMENT IN OCULAR SURFACE AND CATARACT SURGERY - - PROGRESSES IN MANAGEMENT IN OCULAR SURFACE AND CATARACT SURGERY -

CHAIRPERSON’S INTRODUCTION Professor Christina GRUPCHEVA - Bulgaria Moderated Laboratoires Théa’s Satellite Symposium PROGRESSES IN MANAGEMENT IN OCULAR SURFACE AND CATARACT SURGERY held on 15 September 2019 at the XXXVII Congress of the ESCRS in Paris, France.

The first part of the symposium is as an even without prominent evident clinical overview on the concept of dry eye patho- signs is essential. Reducing inflammation is physiology and treatment since the first tear an important target in dry eye disease treat- substitute available in 1902. Over the last ment. This symposium is the opportunity century, dry eye understanding has evolved to have an overview of the new advances in profoundly. Advances in diagnosis and treat- patient management with preservative free, ments of the ocular surface, for instance low-dose hydrocortisone. new bioprotective options such as trehalose The second part of the symposium will and hyaluronic acid (Thealoz® Duo*, labo- concentrate on the use of the intracameral ratoires Théa, France), will be discussed. mydriatic and anaesthetic during cataract Now it is clear that inflammation is among surgery. Mydrane®** is the first standardised the most important mechanisms in the ophthalmic combination of tropicamide pathogenesis of Dry Eye Disease, trigge- 0.02%, phenylephrine 0.31% and lidocaine ring the vicious circle of Dry Eye. That’s why 1%, designed for single-use intracameral decoding inflammation in dry eye disease injection in cataract surgery.

*Thealoz ®Duo, class IIb medical device: Trehalose 3% Sodium Hyaluronate 0.15%. Bioprotection, hydration and lubrication of the eye, for treatment of moderate to severe . **Mydrane®: Solution for injection. Tropicamide 0.2 mg/mL, phenylephrine hydrochloride 3.1 mg/mL, lidocaine hydrochloride 10mg/mL. Indicated for cataract surgery to obtain and intraocular anaesthesia during the surgical procedure in adults only. Mydrane® should only be used in patients who have already demonstrated, at pre-operative assessment, a satisfactory dilation with a topical mydriatic therapy. 5 - PROGRESSES IN MANAGEMENT IN OCULAR SURFACE AND CATARACT SURGERY - - PROGRESSES IN MANAGEMENT IN OCULAR SURFACE AND CATARACT SURGERY -

FROM ARTIFICIAL TEARS TO TARGETED FOCUS ON ARTIFICIAL TEARS tosis is one of the triggering mechanisms in IMPROVEMENT inflammatory ocular surface damage. EYE DROPS Artificial tears may be preserved or preser- PERSONALIZED TREATMENT STEP BY Professor Christina . GRUPCHEVA - Bulgaria vative free. It is nowadays well known and STEP: FOCUS ON TOPICAL DRUGS documented that chronic exposure of the ocular surface to preservatives induces • Treatment step 1 involves a lot of patient’s Since the first tear substitute marketed in Targeted treatment starts with acute toxicity and adverse changes to the ocular education, including lifestyle modifica- tions (humidity, fresh air, nutrition …) and 1902, the concept of dry eye pathophysiology diagnosis of dry eye syndrome. It must be surface. different elements of hygiene. and treatment has evolved profoundly. Today, reminded that patients may have no symp- Available preservative free tear substitutes toms, despite the presence of inflammation powerful topical treatments are needed include: hyaluronic acid (HA), hydroxypropyl • Step 2 adds topical drugs to step 1. at microstructural level. Greater inflamma- methylcellulose (HPMC) and carboxy for faster results, adapted to diurnal and Mild topical corticosteroids are very effec- tion generates visible symptoms and signs methylcellulose (CMC). HA is statistically overnight dynamics of the ocular surface, tive in reducing inflammation by stopping visible at clinical level, such as , and superior to CMC on subjective symptom and and allowing a personalized treatment for the inflammatory cascade at different points. becomes therefore destructive to the deli- on objective measurements, especially on They have been demonstrated to ameliorate efficient and lasting results. Such targeted cate ocular surface. the long term1,2. treatments are made possible by the large the signs and symptoms associated with Distinction must be done between evapo- Ocular residence time is a crucial parameter DED and to prevent DED exacerbation3. choice of eye drops, from aqueous supple- rative dry eye and aqueous deficient dry of efficacy. Indeed, even during sleep, there All steroids are not the same especially mentation to various viscosity-enhancing eye. Then, the treatment is implemented by are rapid eye movements under close in terms of complications and short term agents and anti-inflammatory topical drugs. steps, which all include eye drops and parti- eyelids, and the ocular surface needs to steroids may be beneficial in dry eye. There cularly artificial tears. be lubricated. Ocular residence time not is good evidence, both from clinical and in only depends on viscosity, but on several vitro studies reviewed, that preservative-free Step 1 Step 2 Step 3 Step 4 parameters: mucoadhesion, pH, surface formulations are better tolerated and should Education regarding If above options are inadequate consider: If above options are If above options are tension, tonicity. be preferred for long-term treatments. the condition, its mana- Non-preserved ocular lubricants to mini- inadequate consider: inadequate consider: gement, treatment and mize preservative-induced toxicity Oral secretagogues Topical corticosteroid Cyclosporine A is a fungal-derived peptide prognosis Normal tears viscosity ranges between Tea tree oil treatment for Demodex (if Autologous/allogeneic for longer duration 1.05 and 5.97 mPa.s. Further increases that inhibits T-cell activation and inflam- Modification of local present) serum eye drops Amniotic membrane environment grafts simply result in reflex tearing and blinking matory production. Cyclosporine A • Tear conservation Therapeutic contact Education regarding options Surgical punctal in order to restore the original viscosity inhibits apoptosis by blocking the opening • Punctal occlusion potential dietary occlusion of the mitochondrial permeability transition modifications (including Moisture chamber spectacles/goggles • Soft bandage lenses of tears (homeostasis). Increased visco- oral essential fatty acid Other surgical • Rigid scleral lenses sity in a product might feel cooler and can pore and by increasing the density of conjuc- supplementation) Overnight treatments (such as ointment or approaches (eg tarsor- moisture chamber devices) rhaphy, salivary gland be preferred by some patients, especially tival goblet cells. It is the first agent focused Identification and transplantation) potential modification/ In-office, physical heating and expression of before going to sleep. on the pathogenesis of this disease and can elimination of offending the meibomian glands (including device-as- sisted therapies, such as LipiFlow) be used for long term without significant systemic and topical Well known from food industry, trehalose medications In-office intense pulsed light therapy for adverse effects, and it may be used on longer Ocular lubricants of MGD is a natural bioprotectant/osmoprotectant, periods of time than steroids. various types Prescription drugs to manage DED and was recently developed as an additive to Lid hygiene and warm • Topical or antibiotic/steroid tear substitutes in dry eye treatment. Among Lifitegrast is a novel integrin antagonist, compresses of various combination applied to the lid margins for types anterior (if present) several properties, such as osmoprotection, which competitively antagonizes the LFA-1

• Topical corticosteroid (limited-duration) protein protection, membranes stabiliza- binding to ICAM-1, thus inhibiting T-cell

• Topical secretagogues tion, autophagy induction, the reduction of activation, cytokine release, formation of • Topical non-glucocorticoid immunomodu- apoptosis is particularly interesting as apop- immunological synapse, and subsequently latory drugs (such as cyclosporine)

• Topical LFA-1 antagonist drugs (such as lifitegrast) [Jones L. et al. TFOS DEWS II Management and Therapy Report. • Oral macrolide or tetracycline The Ocular Surface (2017) 615]

1) Groß D et al. Comparative study of 0.1% hyaluronic acid versus 0.5% carboxymethylcellulose in patients with dry eye associated with moderate or keratoconjunc- tivitis. Clin Ophthalmol. 2018;12:1081-8. 2) Prabhasawat P et al. Performance profile of sodium hyaluronate in patients with lipid tear deficiency: randomised, double‐blind, controlled, exploratory study Br J Ophthalmol 2007; 91(1): 47–50. 3) Cutolo CA et al. The Use of Topical Corticosteroids for Treatment of Dry Eye Syndrome. Ocul Immunol Inflamm. 2017; 14:1-10. 6 7 - PROGRESSES IN MANAGEMENT IN OCULAR SURFACE AND CATARACT SURGERY - - PROGRESSES IN MANAGEMENT IN OCULAR SURFACE AND CATARACT SURGERY -

decreasing the ocular inflammatory cycle. participant-reported symptoms and Lifitegrast was found to be a highly potent other objective clinical measures. Thus, DECODING INFLAMMATION IN DRY EYE DISEASE: drug in various clinical trials as it alleviates there might be some benefit in the short- NEW ADVANCES IN PATIENT MANAGEMENT both the signs and symptoms of DED. It term, but there is no evidence of an effect protects the corneal surfaces and is well after two weeks of treatment. Professor Gerhard GARHÖFER – Austria tolerated locally as well as systemically4. • In step 4, the long term use of steroids Personalization of step 2 involves more atten- is proposed, as well as various surgical Inflammation is among the most important known to reduced inflammation by limiting tion to the eyelids and especially Demodex, approaches. Amniotic membranes with topical treatments such as tea tree oil may provide very good results in some mechanisms in the pathogenesis of Dry Eye the mechanics stress to the ocular surface. and relevant terpinen-4-ol products. This patients. Disease, triggering the vicious circle of Dry As such, it has been shown that a 30 days step also include moisture chambers, and Eye. As such pro-inflammatory treatment with a lubricant eye drop solu- Patients must understand from our expla- systemic treatment including tetracyclines. and other inflammatory markers can be tion reduces ocular symptoms and signs nations that the diagnosis and treatment of • Step 3 adds several possibilities to the dry eye is a process taking time and requi- found on the ocular surface of patients with altogether with the inflammation marker previous steps, including serum drops: ring a gradual implementation following Dry Eye Disease, even without prominent HLA-DR9. autologous serum (AS), adult alloge- standardized steps and repeated evaluation. evident clinical signs6. If treatment with lubricants is not sufficient, neic serum, umbilical cord serum or Subjective symptoms assessment may be platelet preparations. The use of AS more comparable if supported by standar- From a pathophysiological point of view, international guidelines recommend the is based on the assumption that AS dized questionnaires such as OSDI. Signs inflammation induces two major conse- use of anti-inflammatory eye drops such as contains biochemical components that are evaluated by a variety of non-invasive quences: tissue destruction and inflamma- topical steroids or cyclosporine. may allow to mimic natural tears more objective tests, likely to quantify the impro- tory cytokines released, which in turn fires Cyclosporin A is a powerful anti-inflamma- closely than artificial tears. But a recent vement. T-BUT, staining and osmolarity up inflammation. The neurosecretory block Cochrane review5 reported inconsistency measurement are probably the most useful tory agent, with proved efficacy in dry eye. leads to a reduction of corneal sensitivity in possible benefits of AS for improving among them. However, the benefit of cyclosporine A is and reflex tear secretion, with a final conse- rather slow to establish, with a full effect quence of a compromised tear film7,8. achieved after 3-6 months of treatment10.

INFLAMMATION AND ITS TWO MAIN CONSEQUENCES Corticosteroids block the whole inflamma- tory cascade of arachidonic acid11. Their

NEUROSECRETORY BLOCK effects in dry eye have been well docu- CONCLUSIONS TISSUE DESTRUCTION Via pro-inflammatory cytokines mented for decades, on symptoms as well as on inflammatory markers, and are achieved Publication numbers on dry eye are growing exponentially since the eighties. Reduction of Loss of sensory Reduction on a rather short time. reflex tear stimulation of corneal The more is known about dry eye pathophysiology, the more personalization of secretion the tear gland sensitivity The downside of corticosteroids is the occur- treatment is feasible. Personalised treatments are complex but they are crucial COMPROMISED TEAR FILM rence of adverse effects after long-term for the management of the patients. use, mainly cataract, with a considerably Thus, reducing inflammation is an important increased risk compared to people not using target in dry eye disease treatment. This can steroids12. A further risk of topical therapy be achieved by different treatment moda- with corticosteroids is , lities. As a first step, topical lubricants are which increases with the relative anti-in-

6) Baudouin C et al. Clinical impact of inflammation in dry eye disease: proceedings of the ODISSEY group meeting. Acta Ophthalmol. 2018;96(2):111-9. 7) Bron et al. Predicted phenotypes of dry eye: proposed consequences of its natural history.Ocul Surf 2009;7:78–92. 8) Lambiase et al. Alterations of tear neuromediators in dry eye disease. Arch Ophthalmol 2011;129:981–6. 9) Fernandez KB et al. Modulation of HLA-DR in dry eye patients following 30 days of treatment with a lubricant eyedrop solution. Clin Ophthalmol. 2015;9:1137-45. 10) Sall et al. Two multicenter, randomized studies of the efficacy and safety of cyclosporine ophthalmic emulsion in moderate to severe dry eye disease. CsA Phase 3 Study Group. Ophthalmology 2000;107(4):631-9. 11) Kim SJ et al. Nonsteroidal anti-inflammatory drugs in ophthalmology. Surv Ophthalmol 2010; 55:108-33 4) Semba CP, Gadek TR. Development of lifitegrast: a novel T-cell inhibitor for the treatment of dry eye disease. Clin Ophthalmol. 2016;10:1083-94 12) Wang JJ et al. Ophthalmology. Use of inhaled and oral corticosteroids and the long-term risk of cataract. 2009;116(4):652-7. 8 5) Pan Q et al. Autologous serum eye drops for dry eye. Cochrane Database Syst Rev. 2017;2:CD009327. 13) Tripathi RC et al. Corticosteroids and risk. Drugs Aging. 1999;15(6):439-50. 9 14) Becker B. Intraocular pressure response to topical corticosteroids. Invest Ophthalmol. 1965;4:198-205. - PROGRESSES IN MANAGEMENT IN OCULAR SURFACE AND CATARACT SURGERY - - PROGRESSES IN MANAGEMENT IN OCULAR SURFACE AND CATARACT SURGERY -

flammatory potency of the drug13,14. Although conducted in 60 patients aged 51±14 years, TO STREAMLINE THE FLOW OF YOUR CATARACT the reason for the IOP increase is not fully with moderate to severe dry eye (DED)15. clarified, there is evidence that it is related SURGERY LIST The main inclusion criteria were a history of to dysfunction of trabecular meshwork cells. DED for at least 3 months, currently treated Professor Rudy NUIJTS - The Netherlands Trabecular Meshwork cells have glucocorti- with topical lubricants for at least 3 months coid receptors. Their biding induces changes and having yet an OSDI score ≥ 22 points in TM cell gene- and protein- expression, and conjunctival hyperemia ≥ Grade 3 on the Most cataract surgeons nowadays strive have multiple systemic side effects, such as inhibit TM cell function (proliferation, migra- Efron Scale. towards cataract surgery that is fast, effi- tachycarida and cardiac arythmia. Finally, tion, phagozytosis) and increases extracellu- cient, and comfortable to the patient. they may reduce the integrity of the ocular After inclusion, patients were randomized lar-matrix deposits (increased synthesis and Optimal mydriasis and anethesia are crucial surface, which may impair visualisation between a standard treatment scheme (8 decreased removal). in improving efficiency of cataract surgery during cataract surgery. days 3 times daily followed by 3 days twice and preventing intraoperative complica- Mydrane® is a solution for intracameral Hydrocortison (HC) was originally developed daily) and an intensive treatment scheme (12 tions: sufficient mydriasis is necessary injection which contains phenylephrine in 1938. HC combines a strong anti-in- days 4 times daily followed by 2 days twice for visualization of the capsulorhexis, lens and tropicamide, as well as lidocaine for flammatory effect with limited penetration daily). A follow up was performed during 28 implantation, and poor mydriasis during additional anesthesia. It is designed for through the and into the anterior days after inclusion. cataract surgery increases the risk of patients undergoing cataract surgery who chamber and thus little effect on intraocular intraoperative complications. The decrease in hyperhemia and OSDI score have demonstrated sufficient pupil dilation pressure. was significant in both groups. No change in With regards to anesthesia, we have already following topical mydriatic administration A new formulation of low concentration IOP has been observed in either group. seen a shift from retrobulbar techniques during the preoperative visit. hydrocortisone 0.335% (Treatment of mild to topical anesthesia in the Netherlands, 16 The purpose of the current study was non-infectious allergic or inflammatory which is more efficient and more comfor- 14 to compare the effectiveness and costs conjunctival diseases Eyedrops) preserva- 12 table to the patient. ® 10 of Mydrane to two alternatives: topical tive-free with reduced penetration through ® 8 A survey amongst 480 european cataract mydriatics and Mydriasert *. The study the cornea may further reduce the incidence Intense Treatment Group 6 surgeons has shown that, when asked what was a single center study in the Zuyderland of IOP rise. To assess this hypothesis, a 4 Standard Treatment Group 2

Intraocular pressure (mmHg) they found most important about mydriasis, Medical Centre, Heerlen, the Netherlands, randomized, active-controlled, investiga- 0 the stability and size of the mydriasis were non-randomized and comparative with tor-blinded, parallel group study has been Visit 1 Visit 2 Visit 3 Visit 4 valued highest (European Observatory of three study groups recruited consecutively. Cataract Surgery , 2015). The main inclusion criterion was patients undergoing cataract surgery under topical Topical mydriasis is still the most common anesthaesia. The main exclusion criteria method used. However, this method has were the presence of ophthalmic disorders CONCLUSIONS several disadvantages. Firstly, it takes time affecting visual acuity or potentially interfe- to achieve proper mydriasis after instilla- ring with surgery, and patients with known Inflammation is one of the key triggers of ocular surface diseases. tion of the eye drops, which requires the incomplete mydriasis as determinded Treatment with preservative-free, low-dose hydrocortisone reduced ocular patient to be present at the hospital well during the preoperative visit. redness and decreased OSDI in both study groups with no change in IOP. in advance of the surgery. Furthermore, Because of its good safety profile, preservative free, low dose hydrocortisone multiple administrations are necessary, The main outcome parameter of the study may be an interesting alternative to standard corticosteroid treatment of ocular which is done by a nurse, to whom wages is incremental costs of the surgery. surface inflammation in dry eye. need to be paid. Topical mydriatics can

® 15) Kallab et al, Topical Low Dose Preservative-Free Hydrocortisone Reduces Signs and Symptoms in Patients with Chronic Dry Eye: A Randomized Clinical * Mydriasert : ophthalmic insert. Tropicamide 0.28 mg/ml, phenylephrine hydrochloride 5.4 mg/ml. Indicated to obtain pre-operative mydriasis, or for diagnostic purposes when Trial. Adv Ther. 2019 Nov 18. doi: 10.1007/s12325-019-01137-8 monotherapy is known to be insufficient. 10 11 - PROGRESSES IN MANAGEMENT IN OCULAR SURFACE AND CATARACT SURGERY - - PROGRESSES IN MANAGEMENT IN OCULAR SURFACE AND CATARACT SURGERY -

TESTED MYDRIATICS KEEP OCULAR SURFACE HEALTHY IN CATARACT

Intracameral Topical eye SURGERY injection Ocular insert drops Professor Jose GÜELL – Spain Dr Spyridoula SOUKI, MD, FEBO – Spain

Cataract surgery is one of the most common eye and the standard eye-drops (oxybupro- surgical procedures performed worldwide. cain chlorhydrate 0.4% + tetracaine chlo- Contains: Contains: Contains: - Lidocaine 1% - Phenylephrine 5.4 mg - Phenylephrine 2.5% It may induce or aggravate dry eye disease, rhydrate 0.1% plus phenylephrine 10% and - Phenylephrine 0.31% - Tropicamide 0.28 mg - Tropicamide 0.5% - Tropicamide 0.02% Administration mode: - Cyclopentolate 1.0% and a proper management of ocular surface tropicamide 1% as mydriatics) in the fellow Administration mode: placed in inferior fornix, Administration mode: pre/postoperatively can increase patient eye. intracamerally, during surgery preoperatively, by nurse 3 X preoperatively, every 10 minutes, by nurse satisfaction. Subjects were randomized (1:1) to receive Pupillary dilatation is commonly achieved by the Mydrane® or standard eye drops for their Secondary outcomes were set as, pupil Davey et al. performed a model-based repeated topical administration of mydriatic/ first surgeries. Surgery of the fellow eye diameter, determined by the ratio between budget impact analysis in UK, evaluating cycloplegic agents before CS that can impact was performed within 7 days after the first white-to-white distance and pupil diameter the costs for one hospital over 1 year (3000 integrity of ocular surface. Intracameral (IC) surgery. Patients were evaluated before, at various critical time points, just before the cataract operations). The direct costs of route of mydriatics delivers direct to the immediately after, 1 day and 7 days after main incision, just before OVD injection, just Mydrane® was £18 000, compared to £3.300 anterior chamber the right dose of drugs to each surgery. achieve pupillary dilatation and may mini- before CCC, just before IOL insertion, and fot the other mydriatics. But the topical The mean OSI obtained from the double-pass mize adverse effects. Furthermore, IC admi- just before cefuroxime injection at the end group had higher nurse costs (£19.400 vs point-spread function image (HD Analyzer) nistration reduces the need of preoperative of surgery. And satisfaction of the cataract £0), resulting in slightly higher total costs for indicated no significant lower intraocular 16 eye drops, mitigating corneal toxicity and surgeons with mydriasis and visualisation topical group : £114 500 vs £108 300 . scattering in Mydrane®, but practical impli- during the case. Patients evaluation by the ocular surface damage. The current study was designed for the cation of better optical quality. CatQuest questionnaire preoperatively and 4 conditions in the Dutch - health system. The EFOS study (EFfects of Mydrane® and weeks postoperatively, and by VAS scale, The parameters of vBUT, obtained from the In Netherladns, Mydrane® has a higher standard topical mydriatics and anaes- ranging from 0 to 10, directly postoperatively. HD Analyzer, indicated no significant diffe- purchase price than topical mydriatics. But thetics protocol on Ocular Surface after rences between eyes. The eyes operated In the current study performed in the price difference may be higher or lower cataract surgery) was designed to assess with Mydrane® had lower OSDI values than Netherlands, Mydrane® is more costly than depending on the country, and the extra cost Mydrane® compared to standard mydriatic standard eye drops group. The difference Mydriasert® and topical mydriatics, which is may be compensated or not by savings on eye-drops protocol in terms of effects on was not statistically significant but was clini- largely related to the higher purchase price other costs components, especially if the ocular surface. cally meaningful. and the longer surgery duration. intracameral injection is nurse time saving. EFOS is a phase IV, open-label, randomized Indeed, as the global patient flow remained clinical trial conducted in the Instituto de However, it is important to realize that a the same during the study it has been diffi- CHANGES IN THE OSDI QUESTIONNAIRE FROM BASELINE Microcirugía Ocular (IMO), Barcelona, Spain. cost analysis is specific to the healthcare cult to assess this criteria. system in which it was performed, and its All surgeries were performed by one expe- - 7 - 6.3 results cannot be directly translated to other An other important limitation of the current rienced surgeon; Prof. José Luis Güell. - 6

countries, for instance, due to differences in study was that the quality of the ocular - 5 50 patients, aged 40 to 88 years, undergoing costs. surface was not investigated. Mydrane® cataract surgery in both eyes were included - 4 - 3.5 being injected in the anterior chamber may - 3 A retrospective study by Labetoulle et al. preserve the ocular surface integrity, which in the study. Inclusion criteria requested - 2 (ESCRS winter meeting 2019) has reported may improve visualization during surgery healthy eyes with pupil size ≥ 7mm and cata- -1 significant delay reduction with intracameral and patient satisfaction as well as post-sur- ract hardness < 3 (LOCS III). 0 mydriatics : mean surgery time reduced by ® gery ocular surface diseases, as shown in Subjects received Mydrane (plus oxybupro- Mydrane® Eye drops 3.19 min, mean room occupancy time by 4.7 other studies. min and mean rotation time between conse- cain chlorhydrate 0.4%+ tetracaine chlorhy- cutive patients by 6.29 min. drate 0.1% as topical anaesthetics) in one

16) Davey K et al. Budget impact model of Mydrane®, a new intracameral injectable used for intra-operative mydriasis, from a UK hospital perspective. BMC 12 Ophthalmol. 2018;18(1):104 13 - PROGRESSES IN MANAGEMENT IN OCULAR SURFACE AND CATARACT SURGERY - - PROGRESSES IN MANAGEMENT IN OCULAR SURFACE AND CATARACT SURGERY -

Fewer epithelial alterations were detected in Mean surgery times were shorter in the eyes operated with Mydrane®. Mydrane® group, first drop to first incision and first eye drops to end of surgery times. 30% of the eyes operated with eye drops had epithelial alterations meanwhile only 8% with Mydrane® group. There were fewer Mean Surgery Time (min)

epithelial alterations detected in eyes that Mydrane® ® received Mydrane 24h after surgery and no 39.2 Eye drops epithelial alterations 7 days after surgery. 40 29.7 CHAIRPERSON’S CONCLUSION Corneal epithelial alterations persisted 30 further than 7 days in some cases with stan- Professor Christina GRUPCHEVA - Bulgaria dard eye-drops. 20 15 Moderated Laboratoires Théa’s Satellite Symposium PROGRESSES IN MANAGEMENT 9 10 10 5 IN OCULAR SURFACE AND CATARACT SURGERY held on 15 September 2019 at the XXXVII PERCENTAGE OF PATIENTS WITH EPITHELIAL ALTERATIONS Congress of the ESCRS in PAris, France. 0 1st drop to end 1st incision to end 1st drop to ® Mydrane of surgery of surgery 1st incision Eye drops 0.4 30% Conjunctival inflammation decreased faster The understanding on dry eye is growing the underlying disease process. Anti-inflam- ® 0.3 in eyes that received Mydrane than those exponentially since the eighties. The more matory eye drops like the new preservative with standard eye-drops. is known about dry eye pathophysiology, free, low-dose hydrocortisone are thus a 0.2 the more personalization of treatment is therapeutic option for breaking the vicious 8% 8.7% Subjective ocular complaints scored with 0.1 ® complex but also crucial. Treatment of Dry inflammatory cycle. 0% OSDI questionnaire were fewer in Mydrane 0% Eye is not just about lubricants. We need ® 0 cases Mydrane is a solution for intracameral also combine strategy with lid hygiene, Day 0 Day 1 Day 7 injection which contains phenylephrine and Patient preparation time/waiting time for lubricants and preservative free anti-inflam- tropicamide, as well as lidocaine for addi- surgery was reduced in the Mydrane® cases matory therapy. Inflammation is recognized Conjunctival staining scores increased tional anesthesia. Mydrane® is effective and and was less stressful for the patient. as having a prominent role in the develop- just after the surgery in both groups. But it safe for initiating and maintaining large and ment and progression of the pathogenesis decreases faster in the eyes operated with 20% of standard eye-drops patients stable mydriasis and analgesia during cata- ® of DED. Inflammation is both a cause and Mydrane . Hyperaemia assessment scores ract surgery. Mydrane® will allow surgeons expressed feeling discomfort during surgery effect of DED. Although artificial tears, even were clinically decreased faster in the and experienced ocular symptoms in the to save time and can help to optimise orga- ® those supplemented with osmoprotectants Mydrane group. nisation of the fast track process through immediate postoperative time. (e.g.trehalose), have been shown to decrease its efficacy. Mydrane® reduces the risk of The percentage of the patients and surgeon hyperosmolarity and ocular surface inflam- Both surgeon and patients felt more comfor- systemic and local side effects seen with the who evaluated the surgery as very satisfac- table and satisfied during eye surgery with mation, they might be not enough to address ® topical drugs. tory were significantly higher in Mydrane Mydrane®. group than eye drops.

CONCLUSIONS

Mydrane® usage in routine cataract surgery reduces corneal epithelial toxicity and ocular surface damage. Faster recovery of ocular surface integrity is achieved with less intraocular scattering and better optical quality. Patient comfort and satisfaction is increased before, during and after surgery.

14 15 Indicated for cataract surgery to obtain mydriasis and intraocular anaesthesia during the surgical procedure in adults only. Mydrane® should only be used in patients who have already demonstrated, at pre-operative assessment, a satisfactory pupil dilation with a topical mydriatic therapy.

Solution for injection Tropicamide 0.2 mg/mL, phenylephrine hydrochloride 3.1 mg/mL, lidocaine hydrochloride 10mg/mL

RAPID PUPIL DILATION DIRECTLY IN THEATRE PROVIDING:

Stable mydriasis

Improved comfort for you and your patients

Anaesthetic effect

More flexibility in the management of the surgical list

A clear Reduction of nurse workload in pre-op allowing them to be more difference available for patients WCORCRESCRS2019-BA

MYDRANE® 0.2 mg/ml + 3.1 mg/ml + 10 mg/ml solution for injection. COMPOSITION: 1 ml of solution for injection contains 0.2 mg of tropicamide, 3.1 mg of phenylephrine hydrochloride and 10 mg of lidocaine hydrochloride. One dose of 0.2 ml solution contains 0.04 mg of tropicamide, 0.62 mg of phenylephrine hydrochloride and 2 mg of lidocaine hydrochloride. Excipient with a known effect: sodium (0.59 mg per dose). Excipients. Indications: MYDRANE® is indicated for cataract surgery to obtain mydriasis and intraocular anaesthesia during the surgical procedure. MYDRANE® is indicated in adults only. Posology: MYDRANE® should only be used in patients who have already demonstrated, at pre-operative assessment, a satisfactory pupil dilation with topical mydriatic therapy. Adults: Slowly inject, by intracameral route, 0.2 ml of MYDRANE® in only one injection, at the start of the surgical procedure. Contraindications: Hypersensitivity to the active substances (tropicamide, phenylephrine hydrochloride and lidocaine hydrochloride) or to any of the excipients. Known hypersensitivity to anaesthetics of the amide type. Known hypersensitivity to atropine derivatives. Pregnancy: MYDRANE® should not be used during pregnancy. Breastfeeding: MYDRANE® should not be used during breast feeding. Undesirable effects: Nervous system disorders (uncommon): Headache. Eye disorders (uncommon): Keratitis, Cystoid macular oedema, Intraocular pressure increased, Posterior capsule rupture, Ocular hyperaemia. Vascular disorders (uncommon): Hypertension. Nature and contents of container: One paper/PVC blister containing 1 ml sterile brown glass (type I) ampoule filled with 0.6 ml of solution for injection. Separated 5-micron sterile filter needles packed in individual blisters are provided. Box of 1, 20 and 100 sterile ampoules together with respectively 1, 20 and 100 5-micron sterile filter needles. Kit of one paper/PVC blister containing one 1 ml sterile brown glass (type I) ampoule filled with 0.6 ml of solution for injection and one 5-micron sterile filter needle. Box of 1, 20 and 100 kits (i.e. blister containing a sterile ampoule and a sterile filter needle). Not all pack sizes may be marketed MARKETING AUTHORISATION HOLDER: Laboratoires THEA - 12, Rue Louis Blériot - 63017 Clermont-Ferrand Cedex 2 – France MARKETING AUTHORISATION NUMBER(S): To be completed nationally. DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION: To be completed nationally. DATE OF REVISION OF THE TEXT: 13 June 2019