FDA

Cyklx

Approved 15 Aug 2025EyeSolution/drops

Indications

CYKLX is indicated for ocular surface anesthesia prior to ocular procedures and/or intraocular injections in adults and pediatric patients. CYKLX is an amide local anesthetic indicated for ocular surface anesthesia prior to ocular procedures and/or intraocular injections in adults and pediatric patients. ( 1 )

Contraindications

CYKLX is contraindicated in patients with known hypersensitivity to any component of this preparation. CYKLX is contraindicated in patients with a hypersensitivity to any component of this preparation. ( 4 )

Warnings and precautions

CYKLX is not for injection or intraocular administration ( 5.1 ) Patients should not touch the eye for at least 10 to 20 minutes after using anesthetic as accidental injuries can occur due to insensitivity of the eye ( 5.2 ) Corneal Opacification : Prolonged use of topical ocular anesthetics may produce permanent corneal opacification and ulceration with accompanying visual loss. ( 5.3 ) Do not touch the dropper tip to the eye, eyelids, or any other surface as this may contaminate the solution ( 5.4 ) For Administration by Healthcare Provider : CYKLX is not intended for patient self-administration ( 5.5 )

5.1For Topical Ophthalmic Use

CYKLX is not for injection or intraocular administration.

5.2Corneal Injury Due to Insensitivity

Patients should not touch the eye for at least 10 to 20 minutes after using CYKLX as accidental injuries can occur due to insensitivity of the eye.

5.3Corneal Opacification

Prolonged use of topical ocular anesthetics may produce permanent corneal opacification and ulceration with accompanying visual loss.

5.4Risk of Contamination Do

not touch the dropper tip to the eye, eyelids, or any other surface as this may contaminate the solution.

5.5For Administration by Healthcare Provider

At a glance

Brand name: Cyklx
Active substance: articaine hydrochloride
Route: Eye
Dosage form: Solution/drops
Applicant: Thea Pharma
Status: Discontinued
FDA approval: 15 Aug 2025
Application: NDA218643-001

Indications

Warnings and precautions

5.1For Topical Ophthalmic Use

CYKLX is not for injection or intraocular administration.

5.2Corneal Injury Due to Insensitivity

Patients should not touch the eye for at least 10 to 20 minutes after using CYKLX as accidental injuries can occur due to insensitivity of the eye.

5.3Corneal Opacification

Prolonged use of topical ocular anesthetics may produce permanent corneal opacification and ulceration with accompanying visual loss.

5.4Risk of Contamination Do

not touch the dropper tip to the eye, eyelids, or any other surface as this may contaminate the solution.

5.5For Administration by Healthcare Provider

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary

There are no adequate and well-controlled studies in pregnant women with CYKLX to inform a drug associated risk. In animal reproduction studies, subcutaneous administration of articaine hydrochloride and epinephrine (1:100,000) to rabbits throughout organogenesis resulted in maternal toxicity, embryofetal death and increased fetal skeletal variations at doses approximately 160 times the maximum recommended human ophthalmic dose (MRHOD) of CYKLX (see Data ) .

The background risk of major birth defects and miscarriage for the indicated population is unknown. However, the background risk in the U.S. general population of major birth defects is 2 to 4%, and of miscarriage is 15 to 20%, of clinically recognized pregnancies. Data Human Data No adequate and well-controlled trials of CYKLX have been conducted in pregnant women. Animal Data In embryo-fetal toxicity studies, subcutaneous administration of articaine hydrochloride and epinephrine (1:100,000) to pregnant rabbits throughout organogenesis produced maternal toxicity, including seizures, at doses of 80 mg/kg/day (approximately 160-fold higher than the bilateral maximum recommended human ophthalmic dose [MRHOD] of 9.6 mg, based on body surface area).

Embryofetal death and skeletal malformations were observed at the same dose Articaine hydrochloride and epinephrine were not maternally toxic and did not produce adverse embryofetal effects in rats and rabbits at oral doses up to 40 mg/kg/day (approximately 40- and 80-fold higher than the MRHOD, respectively). In a pre-/ postnatal developmental study in rats, subcutaneous administration of articaine hydrochloride throughout gestation and lactation resulted in severe maternal toxicity, increased the number of stillbirths and adversely affected passive avoidance, a measure of learning, in pups at a dose of 80 mg/kg (approximately 80 times the MRHOD based on body surface area).

A dose of 40 mg/kg (approximately 40 times the MRHOD based on body surface area) did not produce these effects.

Cyklx

Indications

Contraindications

Warnings and precautions

5.1For Topical Ophthalmic Use

5.2Corneal Injury Due to Insensitivity

5.3Corneal Opacification

5.4Risk of Contamination Do

5.5For Administration by Healthcare Provider

At a glance

Two medicines in one question?

Cyklx

Indications

Contraindications

Warnings and precautions

5.1For Topical Ophthalmic Use

5.2Corneal Injury Due to Insensitivity

5.3Corneal Opacification

5.4Risk of Contamination Do

5.5For Administration by Healthcare Provider

At a glance

Two medicines in one question?

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary

Adverse reactions

6.1Clinical Trials Experience

Composition

Official product information