Delving into the Latest Updates on Latanoprost/Timolol Maleate with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Latanoprost and Timolol Maleate, Timolol/ Latanoprost, 拉坦前列素/马来酸噻吗洛尔

+ [10]

Target

PTGFR x β-adrenoceptors

Mechanism

PTGFR agonists(Prostanoid FP receptor agonists), β-adrenoceptors antagonists(Beta adrenergic receptors antagonists)

Therapeutic Areas

Eye Diseases

Active Indication

GlaucomaGlaucoma, Open-AngleOcular Hypertension+ [1]

Inactive Indication-

Originator Organization

Pfizer Inc.

Active Organization

Pfizer Inc.Pfizer Manufacturing Belgium BV

Novaliq GmbH

+ [1]

Inactive Organization

Viatris, Inc.

Laboratoires Théa SAS

Drug Highest PhaseApproved

First Approval Date

SE (01 Jan 2000),

Glaucoma, Open-AngleGlaucomaOcular Hypertension

RegulationPriority Review (CN)

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Structure

Molecular FormulaC39H64N4O8S

InChIKeyOKKZZTWDFXEJAH-LRWPTBCASA-N

CAS Registry852336-82-4

Glaucoma is a group of chronic eye diseases that are characterized by a progressive optic nerve damage and consequent visual loss. In most cases, it is associated with elevated intraocular pressure. If glaucoma left untreated, complete blindness can occur. Prostaglandin analog- timolol FCs are common glaucoma therapy because these drugs have been shown to effectively lower intraocular pressure (IOP). It is also known that chronic use of preservatives in the drops leads to ocular surface disease (OSD) which can lead to low tolerability of prescribed drops and gaps in the dosing regimen.
The purpose of this study is to investigate whether drug preservative elimination results in reduction of OSD symptoms and signs as well as improvement of latanoprost-timolol FC local tolerability in the treatment of glaucoma and ocular hypertension.
In this trial, on each visit (V1, V2 and V3) following tests will be used: Snellen visual acuity, IOP measurement by Goldman applanation tonometry, OSD signs assessment on the slit lamp (corneal and conjunctival fluorescein surface staining, conjunctival hyperemia and tear film stability assessment using Tear Break- up Time test - TBUT). Visual Analog Scale (VAS) will be used for a subjective assessment of drug tolerability. The association of quality of life and dry eye symptoms in participants will be measured by the Ocular Surface Disease Index (OSDI) questionnaire.

Start Date08 Mar 2021

Sponsor / Collaborator

KBC Zagreb

[+1]

NCT04098861 / Unknown statusPhase 4IIT

Efficacy and Safety of Latanoprost/Timolol Fixed Combination Dosed Twice Daily Compared to Once Daily in Patients With Primary Open Angle Glaucoma

Intraocular pressure (IOP) is the most important modifiable risk factor to prevent and delay progression of glaucoma. IOP reduction has been proven to delay the onset and progression of glaucoma, and uncontrolled IOP is constantly associated with progression of visual field loss.
Medical therapy is the first line in IOP reduction for Primary Open Angle Glaucoma (POAG). It is a known fact that glaucoma patients often require addition of a second antiglaucoma medications when disease progresses or tachyphylaxis occurs. It was reported that more than 50% of patients require 2 or more medications to achieve optimum IOP control.
Nevertheless, compliance and adherence are often impaired with multiple-drug therapy. Combining two ocular hypotensive agents in one bottle may help patients adhere to therapeutic regimen by reducing the number of medications used and the total number of doses administered.

Start Date02 Jan 2019

Sponsor / Collaborator

Hospital Universiti Kebangsaan Malaysia

NCT02278614 / CompletedPhase 3

Efficacy and Safety Assessment of Fixed Combination Unpreserved Latanoprost Eye Drops and Timolol 0.5% (T2347) Versus Xalacom® in Ocular Hypertensive or Glaucomatous Patients.

The objective of the study is to assess the efficacy and safety of T2347 (Latanoprost 0.005% + Timolol 0.5% unpreserved eye drops) versus Xalacom® in ocular hypertensive or glaucomatous patients initially treated, stabilised by Xalacom® or generics (fixed combination Latanoprost 0.005% + Timolol 0.5% preserved eye drops).

Start Date01 Dec 2014

Sponsor / Collaborator

Laboratoires Théa SAS

100 Clinical Results associated with Latanoprost/Timolol Maleate

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100 Translational Medicine associated with Latanoprost/Timolol Maleate

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100 Patents (Medical) associated with Latanoprost/Timolol Maleate

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18

Literatures (Medical) associated with Latanoprost/Timolol Maleate

27 Jan 2022·Journal of current glaucoma practice

In Vitro Toxicity Evaluation of New Generic Latanost® and Latacom® as an Ophthalmic Formulation

Article

Author: Yee, Kar Ming ; Alwi, Nor Amalina Ahmad ; Ng, Jessica Sze Chia ; Tan, Yi Xin ; Tan, Ka-Liong ; Leong, Chuei Wuei ; Rashid, Ahmad Hazri Abdul

AIM AND OBJECTIVE:

To evaluate the safety of two new generic ophthalmic formulations, Latanost^® (latanoprost) and Latacom^® (latanoprost and timolol) by utilizing the three-dimensional reconstructed human cornea-like epithelium (RhCE) tissue constructs as an in vitro model in the assessment of ocular irritation.

MATERIALS AND METHODS:

In vitro irritation test was conducted on Latanost^® (LTN) and Latacom^® (LTC) and their corresponding innovators, Xalatan^® (XLT) and Xalacom^® (XLC), respectively, by using RhCE. According to the OECD guidelines No. 492 on the testing of chemicals, the ophthalmic formulations were assessed via topical exposure of the formulations on in vitro RhCE tissue. Cell viability was measured by MTT assay.

RESULTS:

The mean cell viability percentage of LTN and XLT was 70.5 and 75.7%, respectively, whereas, for LTC and XLC, the percentage viability was 95.3 and 85.7%, respectively. The two new generic formulations (LTN and LTC) did not reduce the cell viability of the RhCE tissue to ≤60%. Thus, both can be considered as nonirritant.

CONCLUSION:

Both newly developed generics are nonocular irritants.

CLINICAL SIGNIFICANCE:

This study informs the safety assessment of new generic antiglaucoma ophthalmic solutions applicable for long-term glaucoma treatment. The formulations aim to keep eye irritation to a minimum level.

HOW TO CITE THIS ARTICLE:

Ng JSC, Tan YX, Alwi NAA, et al. In Vitro Toxicity Evaluation of New Generic Latanost^® and Latacom^® as an Ophthalmic Formulation. J Curr Glaucoma Pract 2021;15(3):139-143.

01 Jan 2022·Vestnik oftalmologii

Xalacom: possibilities and advantages of the drug in the treatment of patients with glaucoma

Review

Author: Volkova, A V ; Alekseeva, L I ; Alekseev, I B

The strategy of glaucoma therapy is aimed at preserving visual functions and ensuring an acceptable quality of life for patients. To achieve this strategic goal, clinicians in their practice use drugs that affect the main factor in the progression of the disease - intraocular pressure (IOP), aiming to reduce it to an individual target level. It is not always possible to achieve optimal IOP values with monotherapy. Many patients require a combination of drugs from different pharmacological groups. Xalacom is a fixed drug with good tolerability and t hypotensive effect. This review focuses on the benefits of this drug for the treatment of glaucoma.

01 Jun 2019·Journal of glaucomaQ3 · MEDICINE

Noninferiority of Preservative-free Versus BAK-preserved Latanoprost-timolol Fixed Combination Eye Drops in Patients With Open-angle Glaucoma or Ocular Hypertension

Q3 · MEDICINE

Article

Author: Csutak, Adrienne ; Lavín-Dapena, Cosme ; Aptel, Florent ; Nordmann, Jean-Philippe ; Astakhov, Yury S. ; Moreno-Montañés, Javier ; Jugaste, Tiia ; Coupier, Laurent ; Żarnowski, Tomasz ; Stalmans, Ingeborg ; Schmickler, Stefanie ; Pfeiffer, Norbert ; Clarke, Jonathan ; Volksone, Lāsma

Précis::

Noninferiority of efficacy was demonstrated for a preservative-free latanoprost-timolol fixed combination compared with a BAK-containing formulation at 84 days after treatment in patients with open-angle glaucoma or ocular hypertension.

Purpose::

The purpose of this study was to compare the effect on intraocular pressure and safety of preservative-free latanoprost-timolol fixed combination (T2347) to benzalkonium chloride-preserved latanoprost-timolol fixed combination in patients with open-angle glaucoma or ocular hypertension.

Methods::

Phase III, randomized, parallel-group, investigator-masked study in 10 countries. A total of 242 patients aged 18 years or older with open-angle glaucoma or ocular hypertension in both eyes controlled with a preserved latanoprost-timolol fixed combination (15.7±2.4 mm Hg overall before inclusion) were randomized at day 0 with no washout period to receive the preservative-free alternative T2347 (N=127) or remain on the preserved comparator (N=115) for 84 days. Intraocular pressure changes from day 0 were measured at 9:00 am (±1 hour) on day 42 and day 84, and noninferiority of T2347 to the preserved comparator was analyzed statistically at day 84. Safety parameters were also reported.

Results::

The mean change in intraocular pressure from baseline to day 84 was −0.49±1.80 mm Hg for preservative-free T2347 and −0.49±2.25 mm Hg for the preserved comparator. These results met the noninferiority limits. Similar results were observed at day 42. There was no difference between groups in the incidence of adverse events or ocular signs. The total ocular symptoms score was better for T2347 than BPLT upon instillation at day 84 (45.9%/44.3%/9.8% of patients with improvement/no change/worsening vs. 33.6%/47.3%/19.1%; P=0.021), reflecting improvements in individual symptoms such as irritation/burning/stinging (P<0.001), and itching (P<0.01) on day 84.

Conclusions::

Preservative-free latanoprost-timolol fixed combination T2347 showed noninferior efficacy compared with the preserved comparator and was well tolerated.

1

News (Medical) associated with Latanoprost/Timolol Maleate

31 Oct 2024

·www.prnewswire.com

Formosa Pharmaceuticals and DÁVI Farmacêutica Announce Licensing Agreement for Clobetasol Propionate Ophthalmic Suspension for the Treatment of Post-Operative Inflammation and Pain

TAIPEI, Oct. 31, 2024 /PRNewswire/ -- Taiwan-based Formosa Pharmaceuticals ("Formosa", 6838.TW) announced today that the company has entered into an exclusive licensing agreement with DÁVI Farmacêutica ("DÁVI") in Portugal, for exclusive rights to the commercialization of clobetasol propionate ophthalmic suspension, 0.05% (APP13007), a marketed innovative medicine for the treatment of inflammation and pain following ocular surgery. DÁVI is a trusted partner of Pharmathen Global Holding B.v., AZAD Pharma AG, NTC S.r.l. and Pfizer through marketing and promotion of Xalacom© (Latanoprost + Timolol) and Xalatan© (Latanoprost) for more than 12 years. DÁVI is one of the key players in the Portuguese Market, with over 100 years' history in the distribution and promotion of branded ophthalmology products. Clobetasol propionate ophthalmic suspension, 0.05% (APP13007), approved by the U.S. Food and Drug Administration (FDA) in March, 2024, was recently launched in the United States in September, 2024. The DÁVI licensing agreement includes upfront, commercialization milestones, and sales milestones, with additional considerations throughout the term of the agreement. APP13007's active ingredient is the superpotent corticosteroid, clobetasol propionate, and is derived from Formosa Pharma's proprietary APNT® nanoparticle formulation platform. The novel formulation enables a convenient and straightforward dosing regimen (twice daily for 14 days) while providing rapid and sustained relief of inflammation and pain. In a recent survey of 100 ophthalmic surgeons, rapid resolution of pain (~80% pain-free four days post-surgery) and low incidence of adverse events (<2%) were highlighted as key drivers to prescribing APP13007. APP13007 anticipates significant potential in Portugal, which has around 90,000 cataract surgeries, annually, as reported by Eurostat. "This partnership with DÁVI Farmacêutica, marks our first entry into a competitive EU market, opening the door for growth into other EU territories. DÁVI's experience and commitment to novel ophthalmic therapies is steadily apparent and Formosa Pharma appreciates their recognition of APP13007 as a worthy offering to patients recovering from ocular surgery." said Erick Co, President and CEO of Formosa Pharmaceuticals. Rui Alves, Business Development Manager of DÁVI Farmacêutica, stated, "We are excited at DÁVI to be partnering with Formosa and have the opportunity to offer this cutting-edge drug and technology to our ophthalmologists and patients, reinforcing our strong position in the market and the commitment to enhance the well-being of our people." About Formosa Pharmaceuticals, Inc. Formosa Pharmaceuticals, Inc. (6838.TW) is a clinical stage biotechnology company with primary focus in the areas of ophthalmology and oncology. The company's proprietary nanoparticle formulation technology (APNT®), through which APP13007 was developed, improves the dissolution and bioavailability of APIs for topical, oral, and inhaler administration. Resulting formulations have high uniformity, purity, and stability, thereby allowing the utilization of poorly soluble or extremely potent drug agents which otherwise may face insurmountable challenges in safety, delivery, and penetration to target tissues. For more details about Formosa Pharma and APNT®, visit . About DÁVI Farmacêutica DÁVI Farmacêutica, is a century-old company and one of the key players in ophthalmology and ENT segments in Portugal. The company's core activities are the distribution & promotion of branded medicines with significant partnerships with major multinational pharmaceutical companies. Our daily mission is to give our patients the best option available in the market, making their lives better. To know more about DÁVI Farmacêutica, visit . SOURCE Formosa Pharmaceuticals Inc., WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

License out/inDrug Approval

100 Deals associated with Latanoprost/Timolol Maleate

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External Link

KEGG	Wiki	ATC	Drug Bank
-	-	S01ED51	-

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Glaucoma	SE	Pfizer Inc.	01 Jan 2000
Glaucoma, Open-Angle	SE	Pfizer Inc.	01 Jan 2000
Ocular Hypertension	SE	Pfizer Inc.	01 Jan 2000

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Dry Eye Syndromes	Preclinical	DE	Novaliq GmbH	11 Jun 2024

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ARVO2018	Not Applicable	-	-	T2347	yxgjdawihl(jfqbudgltu) = nrecekrcux jobmehlsin (wctxsycunv )	-	01 Jul 2018
				Xalacom	yxgjdawihl(jfqbudgltu) = wwgkfwneqx jobmehlsin (wctxsycunv )
ARVO2017	Phase 3	Glaucoma, Open-Angle \| Ocular Hypertension	-	Preservative-free fixed combination latanoprost-timolol (T2347)	twgvslaosp(heixwdcssm) = Itching on D84 was less severe for T2347 than BPLT (p=0.010), and itching throughout the day was also less severe for T2347 than BPLT on D84 (p<0.001) mgbgugayjd (shblrrcfpj ) View more	-	07 May 2017
				Benzalkonium chloride (BAK)-preserved latanoprost-timolol (BPLT, Xalacom ®)
NCT02278614 (CTgov)	Phase 3	Glaucoma, Open-Angle	242	T2347 (T2347)	xkewfpmhtd(nbtxgzsgcx) = ugykpmskxc xsfwywjarj (yjelkhwutv, igxhnaadox - vvkhovffsq) View more	-	23 Jan 2017
				Xalacom (Xalacom)	xkewfpmhtd(nbtxgzsgcx) = kukqopirnq xsfwywjarj (yjelkhwutv, hsylcfafkv - xsajfwnrdj) View more
NCT00706927 (ARVO2011)	Not Applicable	Ocular Hypotension	-	Latanoprost/timolol (Xalacom)	hnstmoqywb(ecbdevnozz) = tclxeobbfj irkldqqkbh (vzjdcugplt )	-	01 Apr 2011
				Brimonidine/timolol (Combigan)	hnstmoqywb(ecbdevnozz) = jljqtwjfxp irkldqqkbh (vzjdcugplt )
NCT00230763 (Pubmed)	Phase 3	Glaucoma, Open-Angle	383	Latanoprost/timolol fixed combination	slwmkwulms(ttwjcottpd) = mjkxcfbaxe trnxklnjuz (zicapockqt )	Positive	26 Mar 2010
NCT00383019 (CTgov)	Phase 3	Glaucoma, Open-Angle	300	KP2035 (KP2035 Group)	vtwljcyspr(tqcylyflws) = nxeojhmobz jbtbfglump (uvbtnunare, aaozqnzmii - tkomonmlks) View more	-	27 May 2009
				Xalatan (Xalatan Group)	vtwljcyspr(tqcylyflws) = ubabxakbsd jbtbfglump (uvbtnunare, wcqoshiwql - urytcwykip) View more
NCT00397241 (ARVO2008)	Phase 4	Glaucoma, Open-Angle	31	Dorzolamide/Timolol Fixed Combination (DTFC)	vzomxgsamt(mebtpjydun) = zewrrissrb oujwwskiyl (enwlgtzplk, 3.2)	-	01 May 2008
				Latanoprost/Timolol Fixed Combination (LTFC)	vzomxgsamt(mebtpjydun) = iacdtjllha oujwwskiyl (enwlgtzplk, 3.1)
NCT00330577 (ARVO2007)	Phase 4	Glaucoma, Open-Angle	28	Latanoprost/Timolol Fixed Combination (LTFC) qpm	kzuwuqnnzr(rgjcvyuvdf) = trjdiadumc jdlxqmrpgy (ioglflfmlg )	Positive	01 May 2007
ARVO2005	Not Applicable	-	50	Xalacom (Timolol 0.5% + Latanoprost 0.005%)	eterjiedkg(uttrnevrvl) = vumrdrkvlw tmuhzrycac (qwakuuwsxe ) View more	Positive	01 May 2005
				Lumigan (Bimatoprost 0.03%)	eterjiedkg(uttrnevrvl) = gbhybqxujn tmuhzrycac (qwakuuwsxe ) View more
ARVO2005	Not Applicable	Ocular Hypertension \| Glaucoma, Open-Angle	-	Xalacom	kexuwqkdfe(jjtxlaarvy) = sncglzkqnu drtiijzgqw (mydfjfkzgn, 3.2)	-	01 May 2005
				Xalatan+Timoptic XE	kexuwqkdfe(jjtxlaarvy) = ncgakxsbpq drtiijzgqw (mydfjfkzgn, 2.8)