Delving into the Latest Updates on Tropicamide/Lidocaine/Phenylephrine with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Fydrane, Lidocaine/phenylephrine/tropicamide, Mydane

+ [4]

Target

SCNA x mAChRs

Mechanism

SCNA modulators(Sodium channel alpha subunit modulators), mAChRs antagonists(Muscarinic acetylcholine receptor antagonists)

Therapeutic Areas

Nervous System DiseasesEye DiseasesOther Diseases

Active Indication

MiosisAnesthesia

Inactive Indication

Cataract

Originator Organization

Laboratoires Théa SAS

Active Organization

Laboratoires Théa SAS

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

GB (16 Jun 2016),

Anesthesia

Regulation-

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Structure

Molecular FormulaC9H13NO2

InChIKeySONNWYBIRXJNDC-VIFPVBQESA-N

CAS Registry59-42-7

View All Structures (3)

Purpose To evaluate and compare the pain experience and discomfort during cataract surgery and over the 24 hours after surgery in patients undergoing either topical anesthesia alone or topical anesthesia plus intracameral anesthesia, provided by using a standard topical anesthesia regimen and a 0.2-mL dose of Mydrane®. Methods Prospective study involving 100 patients who underwent cataract surgery receiving either topical anesthesia alone (group 1, n = 50) or topical anesthesia plus intracameral anesthesia (group 2, n = 50) between January 2021 and March 2022. The pain experienced by patients during and after surgery was assessed using a pain scale and a questionnaire. One hour after surgery, patients were asked to rate the intensity of discomfort they experienced throughout the procedure by pointing to a 0–100 Visual Analogue Scale (VAS). Results According to VAS measurements, patients who underwent surgery under topical anesthesia reported more significant pain than those who underwent surgery under topical anesthesia plus intracameral anesthesia during and over the 24 hours after surgery. ( p = 0.02 and p = 0.01, respectively). Patients undergoing topical anesthesia had 2.34-fold greater odds of having pain during surgery [95% Confidence Interval (CI): 1.58–5.25, p = 0.03]. Conclusions Topical anesthesia plus intracameral anesthesia lower intraoperative and postoperative pain levels, improving patient cooperation and representing a useful analgesic delivery method in cataract surgery.

01 May 2023·European Journal of Ophthalmology

Efficacy of the intracamerally administered mydriatics for cataract surgery in patients with primary open-angle glaucoma

Article

Author: Savastano, Maria Cristina ; Rizzo, Stanislao ; Ripa, Matteo ; Ricci, Francesco ; Grieco, Giulia ; Cuffaro, Giovanni

Purpose To compare Mydrane®, mydriatic eye drops, and Mydriasert® in terms of pupil site stability, surgical time, visual field, and anterior chamber configuration modifications among patients with primary open-angle glaucoma (POAG) during cataract extraction surgery. Methods Retrospective analysis of sixty patients with POAG and cataract who underwent elective cataract extraction. All patients underwent routine ophthalmic examinations, including automatic visual field examination, anterior chamber configuration, specular microscopy, and arterial blood pressure measurement prior to surgery, and 24 h and 30 days postoperatively. All cataract surgeries were video-recorded and all measurements were performed using a media player. Patients divided into groups 1, 2, and 3 (n = 20 in each group) received topical mydriatic eye drops, Mydriasert®, and an intracameral injection of Mydrane®, respectively, immediately after the first incision. Results The mean change in pupil size from just before capsulorhexis to the end of surgery was 0.43 ± 0.09, 0.42 ± 0.08, and 0.36 ± 0.02 mm in groups 1, 2, and 3, respectively. The mean surgery duration was similar among all the groups. The baseline main cell density slightly decreased at 24 h and remained stable for 30 days postoperatively. The mean deviation and pattern standard deviation remained stable at 1 month after surgery. At 24 h after surgery, the nasal irido-corneal angle, temporal-iridocorneal angle, and anterior chamber depth increased compared with the baseline, remaining stable for 30 days after surgery. Conclusions Mydrane® produced adequate and stable mydriasis as effectively as produced by Mydriasert® and topical eye drops.

01 Feb 2023·Acta Ophthalmologica

Pupil diameter during cataract surgery after intracameral injection of the first ready‐to‐use combination of mydriatics and anaesthetic at the beginning of surgery in patients with a preoperative pupil diameter <6 mm

Article

Author: Szaflik, Jerzy ; Omulecki, Wojciech ; Jurowski, Piotr ; Kęcik, Dariusz ; Szaflik, Jacek P. ; Romanowska–Dixon, Bożena ; Mianowska, Katarzyna ; Romaniuk, Wanda ; Kopacz, Dorota ; Mrukwa–Kominek, Ewa ; Grabska‐Liberek, Iwona

AbstractPurposeWe evaluated, in a real‐life setting, the effect of Mydrane® (ready‐to‐use combination of tropicamide, phenylephrine hydrochloride and lidocaine, injected into the anterior chamber at the beginning of cataract surgery to induce mydriasis and intraocular anaesthesia) on the pupil diameter during cataract surgery in patients with a preoperative pupil diameter <6 mm after the use of topical mydriatics.MethodsWe collected and analysed the data of 59 consecutive patients whose pupils dilated to a diameter <6 mm after the administration of mydriatic eye drops during the preoperative visit and who received Mydrane® during cataract surgery.ResultsIn the group of 59 patients with a preoperative pupil diameter <6 mm after topical mydriatics, cataract surgery was performed in 36 patients (61.0%) using only Mydrane® to obtain mydriasis, with no additional drug or medical device. The mean pupil diameters in this group (36 of 59) during the preoperative assessment after topical mydriatics and just before capsulorhexis when Mydrane® was injected during surgery were 5.1 ± 0.74 and 6.15 ± 1.14 mm. Additional drugs were used in 23 patients (39%). In this group, the mean pupil diameters after topical mydriatics and just before capsulorhexis using Mydrane® were 4.58 ± 1.06 and 5.6 ± 1.26 mm, respectively.ConclusionIn a real‐life setting, the mean pupil diameter achieved during cataract surgery after the intracameral injection of Mydrane® in patients with a preoperative pupil diameter <6 mm was over 1 mm larger than the mean pupil diameter after topical mydriatics, despite the trauma caused by the operation.

100 Deals associated with Tropicamide/Lidocaine/Phenylephrine

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External Link

KEGG	Wiki	ATC	Drug Bank
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R&D Status

Approved

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Indication	Country/Location	Organization	Date
Miosis	GB	Laboratoires Théa SAS	24 Jul 2016
Anesthesia	GB	Laboratoires Théa SAS	16 Jun 2016

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Cataract	Phase 1	FR	Laboratoires Théa SAS	01 Jun 2011

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ARVO2019	Not Applicable	-	69	Mydrane alone	(atacqevafh) = tuaspntqnl pfovutiqkt (atsgtgmprh ) View more	Negative	01 Jul 2019
				Tropicamide plus Mydrane	(atacqevafh) = ylxlvokmro pfovutiqkt (atsgtgmprh ) View more