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BETOPTIC S

Phase 3FDA approved

Glaucoma | Small molecule | Ophthalmology |Alcon Inc.|Trials Updated: Nov 18, 2016

BETOPTIC S development status

FDA approval on record Jun 8, 2007
Approval holderNovartis
ApplicationNDA019845
Highest phase Phase 3

Label indication BETOPTIC S ® (betaxolol hydrochloride ophthalmic suspension) 0.25% is indicated for the treatment of elevated intraocular pressure (IOP) in patients with chronic open-angle glaucoma or ocular hypertension. BETOPTIC S is a beta-adrenergic receptor inhibitor indicated for the treatment of elevated intraocular pressure (IOP) in patients with chronic open-angle glaucoma or ocular hypertension. ( 1 ) FDA label

BETOPTIC S target and mechanism

ModalitySmall molecule

Also known as BETOPTIC S (betaxolol HCl)

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment105

FDA Designations

No designations recorded

BETOPTIC S clinical trials

BETOPTIC S · 1 trial · 2 indications

Phase 3 1
NCT00061542Safety and Efficacy Study of BETOPTIC S 0.25% and Timolol Gel-forming Solution 0.25% and 0.5% in Pediatric Patients With Glaucoma or Ocular HypertensionGlaucoma
COMPLETED105 Analytics
PHASE3COMPLETED
Safety and Efficacy Study of BETOPTIC S 0.25% and Timolol Gel-forming Solution 0.25% and 0.5% in Pediatric Patients With Glaucoma or Ocular Hypertension
GlaucomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Mean change from baseline in IOP
Up to Week 12
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
BetaxololEXPERIMENTALTwo doses daily for 12 weeks
TGFS 0.25%EXPERIMENTALTwo doses daily for 12 weeks
TGFS 0.5%EXPERIMENTALTwo doses daily for 12 weeks

Interventions

NameTypeDescription
BETOPTIC S (betaxolol HCl)DRUGbetaxolol HC)
Timolol Gel-forming Solution (TGFS)DRUGtimolol maleate 0.25% and 0.5%
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Eligibility Criteria

Age Range1 Week to 5 Years
SexMALE
Healthy VolunteersNo
Study Sites1

INCLUSION: * Children 5 years old and younger * require treatment for glaucoma or ocular hypertension * whose vision is 20/80 or better * have a cup-to-disc ratio of 0.8 or less EXCLUSION: * do not have abnormal fixation * IOP greater than 36 mm Hg * significant retinal disease * penetrating kera...

Countries:United States
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Frequently asked questions about BETOPTIC S

What is BETOPTIC S used for?

BETOPTIC S is used to treat glaucoma and ocular hypertension, conditions in which elevated pressure inside the eye can damage the optic nerve. It is an ophthalmic solution developed by Alcon Inc. (ticker ALC) and was studied in pediatric patients as young as one week old with glaucoma or ocular hypertension.

Who makes BETOPTIC S?

BETOPTIC S is made by Alcon Inc., which trades under the ticker ALC. Alcon is an eye care company, and BETOPTIC S is part of its ophthalmology portfolio. The drug was evaluated in a company-sponsored Phase 3 trial conducted in the United States.

What phase is BETOPTIC S in?

BETOPTIC S has been studied in Phase 3 clinical development for glaucoma and ocular hypertension. One Phase 3 trial has been completed, and no trials are currently listed as active. The completed study was randomized, double-blind, and controlled, enrolling 105 pediatric patients.

What clinical trials is BETOPTIC S in?

BETOPTIC S was evaluated in the Phase 3 trial NCT00061542, titled a safety and efficacy study of BETOPTIC S 0.25% and timolol gel-forming solution 0.25% and 0.5% in pediatric patients with glaucoma or ocular hypertension. The trial enrolled 105 participants in the United States and is completed.

Is BETOPTIC S the same as betaxolol HCl?

Yes, BETOPTIC S is also known as BETOPTIC S (betaxolol HCl). Betaxolol HCl is the active ingredient in the ophthalmic solution. Readers searching for either name are looking at the same Alcon Inc. product studied for glaucoma and ocular hypertension.