Delving into the Latest Updates on Bimatoprost/Brimonidine Tartrate/Timolol with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Bimatoprost/brimonidine/timolol, Bimatoprost/timolol/brimonidine, Timolol/brimonidine/bimatoprost

Target

ADRA2 x Prostanoid receptor x β-adrenoceptors

Action

agonists, antagonists

Mechanism

ADRA2 agonists(Adrenergic receptors alpha-2 agonists), Prostanoid receptor agonists, β-adrenoceptors antagonists(Beta adrenergic receptors antagonists)

Therapeutic Areas

Eye Diseases

Active Indication-

Inactive Indication

GlaucomaGlaucoma, Open-Angle

Originator Organization

Allergan UC

Active Organization-

Inactive Organization

Allergan UC

License Organization-

Drug Highest PhasePendingPhase 3

First Approval Date-

Regulation-

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Structure/Sequence

Molecular FormulaC15H16BrN5O6

InChIKeyQZHBYNSSDLTCRG-LREBCSMRSA-N

CAS Registry70359-46-5

View All Structures (3)

A Multicenter, Open-label Study to Evaluate the Safety and Efficacy of Twice-daily 0.01% Bimatoprost/0.15% Brimonidine/0.5% Timolol Ophthalmic Solution (Triple Combination) in Patients in India, Who Have Glaucoma or Ocular Hypertension With Elevated IOP, and Are on Twice-daily 0.2% Brimonidine/0.5% Timolol Ophthalmic Solution (Dual Combination) Therapy

This study will investigate the safety and efficacy of Triple Combination Therapy (bimatoprost/brimonidine tartrate/timolol fixed combination ophthalmic solution) in patients with glaucoma or ocular hypertension who have elevated intraocular pressure (IOP) on brimonidine/timolol ophthalmic solution.

Start Date01 Nov 2010

Sponsor / Collaborator

Allergan UC

100 Clinical Results associated with Bimatoprost/Brimonidine Tartrate/Timolol

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100 Translational Medicine associated with Bimatoprost/Brimonidine Tartrate/Timolol

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100 Patents (Medical) associated with Bimatoprost/Brimonidine Tartrate/Timolol

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2

Literatures (Medical) associated with Bimatoprost/Brimonidine Tartrate/Timolol

01 Feb 2020·Clinical TherapeuticsQ4 · MEDICINE

Fixed-combination Bimatoprost/Brimonidine/Timolol in Glaucoma: A Randomized, Masked, Controlled, Phase III Study Conducted in Brazil☆

Q4 · MEDICINE

Article

Author: Della Paolera, Mauricio ; Paula, Jayter Silva ; Belfort, Rubens ; Goodkin, Margot L ; Kim, Thomas ; Chen, Michelle Y ; Lopes Silva, Marcelo Jordão

PURPOSEMany patients with open-angle glaucoma eventually require >2 medications to lower their intraocular pressure (IOP). Fixed-combination ophthalmic solutions can be advantageous in patients who require multiple medications, but the number of fixed combinations combining 3 complementary IOP-lowering agents remains limited. This study assessed the efficacy and safety of a triple fixed combination (TFC) of bimatoprost 0.01%/brimonidine 0.15%/timolol 0.5% ophthalmic solution in patients with primary open-angle glaucoma (POAG) or ocular hypertension (OHT), compared with a dual fixed combination (DFC) of brimonidine 0.2%/timolol 0.5%.METHODSPatients with a baseline IOP of 23-34 mm Hg in both eyes and no history of IOP-lowering procedures were eligible for participation in this multicenter, double-masked, randomized, Phase III study. After washout of previous treatment (if applicable), patients were randomized to receive TFC or DFC twice daily in each eye for 3 months. The primary efficacy variable was the change from baseline in mean IOP in the worse eye at week 12 in the modified intent-to-treat (mITT) population. TFC was superior to DFC if the treatment difference (TFC - DFC) favored TFC at week 12 (P ≤ 0.05; 2-sample t test). Secondary and sensitivity analyses were also performed. Safety, including adverse events, was assessed at all visits.FINDINGSThe mITT/safety population included 185 patients (TFC, n = 90; DFC, n = 95). TFC superiority was demonstrated at all postbaseline visits (all, P < 0.001) through week 12 (week 12 treatment difference: ─2.17 mm Hg; 95% CI, ─3.12 to ─1.22). While treatment-related conjunctival hyperemia was more frequent with TFC than with DFC (47.8% vs 23.2%; P < 0.001), consistent with the additional presence of bimatoprost in TFC, most cases were mild and the numbers of patient discontinuations at week 12 were similar between the TFC and DFC groups (11 [12.2%] vs 7 [7.4%] patients; P = 0.266). No unexpected adverse events were reported.IMPLICATIONSCompared with DFC, TFC provided superior IOP lowering throughout the primary efficacy period. An acceptable tolerability profile was observed through 12 months of use of TFC, offering an effective therapeutic option in patients with POAG or OHT who require multiple medications to control their IOP. Additional studies are required for the assessment of the long-term effects of TFC. ClinicalTrials.gov identifier: NCT01217606.

01 Jan 2017·Journal of OphthalmologyQ4 · MEDICINE

A Masked, Randomized, Phase 3 Comparison of Triple Fixed-Combination Bimatoprost/Brimonidine/Timolol versus Fixed-Combination Brimonidine/Timolol for Lowering Intraocular Pressure

Q4 · MEDICINE

ArticleOA

Author: Goodkin, Margot ; Batoosingh, Amy ; Bernstein, Paula ; Hartleben, Curt ; Parra, Juan Camilo

Objective.To evaluate the efficacy and safety of triple fixed-combination bimatoprost 0.01%/brimonidine 0.15%/timolol 0.5% (TFC) versus dual fixed-combination brimonidine 0.2%/timolol 0.5% (DFC) in primary open-angle glaucoma and ocular hypertension.Methods.Patients with intraocular pressure (IOP) ≥23 and ≤34 mmHg were randomized to twice-daily TFC or DFC. The primary variable is the change in worse eye mean IOP from baseline at week 12 (modified intent-to-treat (mITT) population). Secondary endpoints are mean IOP and mean change from baseline at weeks 1, 2, 4, 8, and 12 (mITT population). TFC superiority was demonstrated if the primary variable favored TFC (p≤0.05). Sensitivity analyses were conducted, and safety was assessed at all visits.Results.TFC (n=93) provided greater IOP reductions from baseline than DFC (n=97) at week 12 (treatment difference, 0.85 mmHg;p=0.028) and all other visits. TFC was also superior to DFC in patients with high baseline IOP (i.e., IOP ≥ 25 mmHg;p≤0.011). Conjunctival hyperemia, ocular irritation, and dry eye were reported more often with TFC (p≤0.016); however, discontinuations for ocular adverse events were similar between treatments.Conclusions.TFC demonstrated IOP-lowering benefits that outweigh the risk of predominantly mild ocular side effects, which may be particularly relevant in patients who require greater IOP lowering to prevent/delay disease progression. This trial is registered with ClinicalTrials.gov registry number:NCT01241240.

100 Deals associated with Bimatoprost/Brimonidine Tartrate/Timolol

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Glaucoma, Open-Angle	Phase 3	Brazil	Allergan UC	01 Jan 2011
Glaucoma	Phase 3	India	Allergan UC	01 Nov 2010

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01217606 (CTgov)	Phase 3	Glaucoma, Open-Angle	185	bimatoprost/brimonidine tartrate/timolol ophthalmic solution (Triple Combination Therapy) (Triple Combination Therapy)	xpuyvsxzku(rmxhpxwhng) = xokugygeut rpedkqrnfq (odhyyjjhhq, mkepscygwt - kqefaoddyf) View more	-	09 Nov 2015
				Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution (Combigan®)	xpuyvsxzku(rmxhpxwhng) = hgppqxcbcl rpedkqrnfq (odhyyjjhhq, zkshtmfobv - dzmyojfjgc) View more
NCT01241240 (CTgov)	Phase 3	Glaucoma, Open-Angle	192	bimatoprost/brimonidine tartrate/timolol ophthalmic solution (Triple Combination Therapy) (Triple Combination Therapy)	qbnwfebpcq(emsmbgdysu) = iurqhuwcaq uitxathgxo (vsoeiaculh, momdcjojbf - naiqdbyrpb) View more	-	10 Sep 2014
				Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution (Combigan®)	qbnwfebpcq(emsmbgdysu) = ybxhvdrxgr uitxathgxo (vsoeiaculh, vkesywhmxm - gecycleonk) View more
NCT01216943 (CTgov)	Phase 3	Glaucoma	126	bimatoprost/brimonidine tartrate/timolol fixed combination ophthalmic solution	pjcnrzgiai(pmhxfbjgzz) = vmvalsmrxb uiqalashdm (rodntumuic, gefjvtmzlw - daobpmjsuh) View more	-	19 Sep 2013