Delving into the Latest Updates on Dorzolamide Hydrochloride/Timolol Maleate/Brimonidine Tartrate with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Brimonidine/dorzolamide/timolol, Krytantek PF

+ [2]

Target

ADRA2 x CAs x β-adrenoceptors

Action

agonists, inhibitors, antagonists

Mechanism

ADRA2 agonists(Adrenergic receptors alpha-2 agonists), CAs inhibitors(Carbonic anhydrases inhibitors), β-adrenoceptors antagonists(Beta adrenergic receptors antagonists)

Therapeutic Areas

Eye Diseases

Active Indication

GlaucomaOcular Hypertension

Inactive Indication

Glaucoma, Open-Angle

Originator Organization

Laboratorios Sophia SA de CV

Active Organization

Laboratorios Sophia SA de CV

Inactive Organization-

License Organization-

Drug Highest PhaseApproved

First Approval Date

Mexico (01 Sep 2007),

GlaucomaOcular Hypertension

Regulation-

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Structure/Sequence

Molecular FormulaC15H16BrN5O6

InChIKeyQZHBYNSSDLTCRG-LREBCSMRSA-N

CAS Registry70359-46-5

View All Structures (3)

Phase IV randomized, double blind, multicenter, parallel group clinical study to evaluate the efficacy of the combined use of Krytantek Ofteno PF® and Gaap Ofteno PF®, both applied every 12 hours, versus the use of Eliptic Ofteno PF® Plus Gaap Ofteno PF®, both applied every 12 hours, in patients with open angle glaucoma or ocular hypertension during 90 days

Start Date19 Oct 2021

Sponsor / Collaborator

Laboratorios Sophia SA de CV

NCT03966365

/ CompletedPhase 1

Phase I Clinical Study, to Evaluate the Safety and Tolerability of the Preservative-free Ophthalmic Solution PRO-122 Compared With Krytantek Ofteno®, Elaborated by Sophia Laboratories, S.A. of C.V. on the Ocular Surface of Ophthalmologically and Clinically Healthy Subjects

Therapeutic indication: Ocular hypotensive Use: Primary open-angle glaucoma and ocular hypertension.
Objectives: To evaluate the safety and tolerability of the preservative-free formulation PRO-122 manufactured by Sophia Laboratories, S.A. of C.V. on the ocular surface of clinically healthy subjects.
Hypothesis: The ophthalmic solution PRO-122 presents a profile of safety and tolerability similar to Krytantek Ofteno®, in healthy subjects.
Methodology: Phase I clinical trial, controlled, parallel group, double blind, randomized.
Number of patients: n=24 12 subjects per group (both eyes). Main inclusion criteria:Clinically healthy subjects.

Start Date02 May 2019

Sponsor / Collaborator

Laboratorios Sophia SA de CV

100 Clinical Results associated with Dorzolamide Hydrochloride/Timolol Maleate/Brimonidine Tartrate

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100 Translational Medicine associated with Dorzolamide Hydrochloride/Timolol Maleate/Brimonidine Tartrate

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100 Patents (Medical) associated with Dorzolamide Hydrochloride/Timolol Maleate/Brimonidine Tartrate

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1

Literatures (Medical) associated with Dorzolamide Hydrochloride/Timolol Maleate/Brimonidine Tartrate

01 Jun 2018·Ophthalmology and TherapyQ3 · MEDICINE

A Phase III Randomized Clinical Trial of a 0.5% Timolol + 0.2% Brimonidine + 2.0% Dorzolamide Fixed Combination, Preservative-Free Ophthalmic Solution vs. 0.5% Timolol + 0.2% Brimonidine + 2.0% Dorzolamide Fixed Combination in Patients with Controlled Primary Open-Angle Glaucoma

Q3 · MEDICINE

ArticleOA

Author: Davila-Villarreal, Jaime ; García-Velez, Francisco ; Jiménez-Román, Jesús ; Olvera-Montaño, Oscar ; Hartleben, Curt ; Baiza-Durán, Leopoldo ; Gómez-Aguayo, Francisco ; Muñoz-Villegas, Patricia ; Leñero-Córdova, Rubén ; Paczka, José A

AbstractIntroductionThe aim of this prospective crossover study was to evaluate the non-inferiority of PRO-122 (a preservative-free fixed combination) compared with 0.5% timolol + 0.2% brimonidine + 2.0% dorzolamide fixed combination (KOF) by evaluating its efficacy, tolerability and safety in subjects with controlled primary open-angle glaucoma (POAG) previously treated with KOF for at least 2 months.MethodsIn a prospective, crossover, randomized, double-masked multicenter study, patients previously treated with KOF were randomly assigned to receive either PRO-122 or KOF for 30 days. On day 31, the A sequence changed to KOF, while the B sequence received PRO-122. All patients remained in the protocol for 30 additional days for a total of 60 days. The main efficacy endpoint was maintaining the controlled intraocular pressure (IOP). The safety and tolerability of both products were assessed by the presence of adverse events (AEs), ocular findings, a questionnaire on ocular comfort and the VF-14 index.ResultsA total of 51 patients participated. After application of PRO-122 twice a day, its efficacy was demonstrated through maintenance of the controlled IOP in patients previously controlled with KOF. The crossover between PRO-122 and KOF and vice versa, after 30 days of use, did not affect IOP control. PRO-122 was shown not to be inferior to KOF in maintaining IOP at control levels. The safety of both drugs is similar, as neither presented drug-related AEs or differences regarding safety issues. The tolerability of the two medications—evaluated by ocular findings, the questionnaire on ocular comfort and the VF-14 index—was also determined to be similar.ConclusionsThe controlled IOP in patients with controlled POAG treated with PRO-122 was maintained both in relation to the initial controlled IOP of the study and when compared with KOF in the B sequence. Finally, the treatment with PRO-122 demonstrated similar safety and tolerability to KOF.FundingLaboratorios Sophia, S.A. de C.V. (Zapopan, Jalisco, México).Trial RegistrationClinicalTrials.gov identifier: NCT03257813 (registered retrospectively).

100 Deals associated with Dorzolamide Hydrochloride/Timolol Maleate/Brimonidine Tartrate

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External Link

KEGG	Wiki	ATC	Drug Bank
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R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Glaucoma	Mexico	Laboratorios Sophia SA de CV	01 Sep 2007
Ocular Hypertension	Mexico	Laboratorios Sophia SA de CV	01 Sep 2007

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Glaucoma, Open-Angle	Phase 1	-	Laboratorios Sophia SA de CV	01 Apr 2016
Glaucoma, Open-Angle	Preclinical	-	Laboratorios Sophia SA de CV	01 Apr 2016

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03966365 (PRO-122/I, CTgov)	Phase 1	Glaucoma	24	PRO-122 (PRO-122)	lxloyrzslj(yznvzxkeyt) = vihwluqhbp benbqmqing (rkvbqnxgvc, bwgvjdfeeg - uqkqephmhz) View more	-	13 Dec 2019
				Krytantek Ofteno® (Krytantek Ofteno®)	lxloyrzslj(yznvzxkeyt) = vbmqvhqraf benbqmqing (rkvbqnxgvc, lpstojqqvi - ogituxmvyt) View more