These Highlights Do Not Include All The Information Needed To Use Vevye ®

Risk Summary

There are no adequate and well-controlled studies of VEVYE administration in pregnant women to inform a drug-associated risk. Oral administration of cyclosporine to pregnant rats or rabbits did not produce teratogenicity at clinically relevant doses VEVYE doses are approximately 4,700 times lower than recommended oral doses, with blood concentrations being undetectable after topical administration.

Principal Display Panel - 2 mL Carton Label

NDC: 82667-900-02          Rx Only

vevye ^®

(cyclosporine ophthalmic

soliton) 0.1%

For topical application

In the eye

Sterile, Non-Preserved

2 mL

VEVYE (cyclosporine ophthalmic solution) 0.1% contains the immunomodulatory agent cyclosporine. Cyclosporine's chemical name is Cyclo[[€-(2S,3R,4R)-3-hydroxy-4-methyl-2-(methylamino)-6-octenoyl]-L-2-aminobutyryl-N-methylglycyl-N-methyl-L-leucyl-L-valyl-N-methyl-L-leucyl-L-alanyl-D-alanyl-N-methyl-L-leucyl-N-methyl-L-leucyl-N-methyl-L-valyl] and it has the following structure:

Structural Formula

Formula: C ₆₂H ₁₁₁N ₁₁O ₁₂, Molecular weight: 1202.6

Cyclosporine is a white powder that is solubilized in perfluorobutylpentane, a semi-fluorinated alkane vehicle. VEVYE is supplied as a 2 mL sterile, clear, colorless, non-aqueous ophthalmic solution for topical ophthalmic use. VEVYE ^®contains:

• Active: cyclosporine 0.1%
• Inactives: perfluorobutylpentane, ethanol (anhydrous).

The solution does not contain water or anti-microbial preservatives. As a water free product, there is no associated pH and no osmolarity.

Safety and effectiveness in pediatric patients below the age of 18 years have not been established.

No overall difference in safety or effectiveness has been observed between elderly and younger patients.

The safety and efficacy of VEVYE were assessed in a total of 1369 patients with dry eye disease, of which 738 received VEVYE.

In two multicenter, randomized, adequate and well-controlled clinical studies, patients with dry eye disease (CYS-002: NCT02617667 and CYS-004: NCT04523129), treated with VEVYE ^®were compared to patients treated with vehicle. At Day 29, there was a statistically significant higher percentage of eyes with increases of ≥ 10 mm from baseline in Schirmer wetting. This effect was seen in approximately 10% of VEVYE-treated patients versus approximately 6% of vehicle-treated patients.

None.

The most common adverse reaction following the use of VEVYE were instillation site reactions (8%). ( 6.1)

To report SUSPECTED ADVERSE REACTIONS, contact

Harrow at 1-833-4HARROW(427769) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

Following bilateral topical ocular dosing of one drop of VEVYE twice daily, the blood concentrations of cyclosporine were below the limit of quantification (0.1 ng/mL) at all timepoints.

Instill one drop of VEVYE twice a day in each eye approximately 12 hours apart.

VEVYE indicated for the treatment of the signs and symptoms of dry eye disease.

Cyclosporine, a calcineurin inhibitor, is a relatively selective immunomodulatory drug.

Care should be taken to not touch the eye or other surfaces with the bottle tip to avoid potential for eye injury and/or contamination. ( 5.1)

Instill one drop of VEVYE twice a day in each eye approximately 12 hours apart. ( 2)

VEVYE should not be administered while wearing contact lenses. If contact lenses are worn, they should be removed prior to administration of the solution. Lenses may be reinserted 15 minutes following administration of VEVYE ophthalmic solution.

Clear, colorless non-preserved ophthalmic solution containing cyclosporine 0.1% (1 mg/mL), delivering 0.01 mg of cyclosporine per one drop (0.01 mL).

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In clinical trials with 738 subjects receiving at least 1 dose of VEVYE, the most common adverse reactions were instillation site reactions (8%) and temporary decreases in visual acuity (3%).

Wash hands before using.

Gently pull the lower eyelid downward. Tip the bottle upside down over the eye to allow one drop to dispense on its own into the eye. If a drop does not dispense after a few seconds, gently apply slight pressure to the sides of the bottle while holding over the eye.

Note:You may not feel the drop falling into your eye.

If VEVYE is used with other eye drops, a 15-minute interval between products should occur.

Advise patients to read the FDA-approved patient labeling (Instructions for Use).

VEVYE is a sterile, clear, colorless non-aqueous ophthalmic solution packaged in multiple-dose eye drop bottles delivering single drops of approximately 0.01 mL volume. Each unit contains 2 mL of VEVYE in a 5 mL transparent squeezable polypropylene bottle with a transparent polyethylene tip and a white polyethylene cap with tamper-evident ring.

NDC 82667-900-02

To avoid the potential for eye injury and/or contamination, patients should not touch the bottle tip to the eye or other surfaces.

Risk Summary

There are no adequate and well-controlled studies of VEVYE administration in pregnant women to inform a drug-associated risk. Oral administration of cyclosporine to pregnant rats or rabbits did not produce teratogenicity at clinically relevant doses VEVYE doses are approximately 4,700 times lower than recommended oral doses, with blood concentrations being undetectable after topical administration.

Principal Display Panel - 2 mL Carton Label

NDC: 82667-900-02          Rx Only

vevye ^®

(cyclosporine ophthalmic

soliton) 0.1%

For topical application

In the eye

Sterile, Non-Preserved

2 mL

VEVYE (cyclosporine ophthalmic solution) 0.1% contains the immunomodulatory agent cyclosporine. Cyclosporine's chemical name is Cyclo[[€-(2S,3R,4R)-3-hydroxy-4-methyl-2-(methylamino)-6-octenoyl]-L-2-aminobutyryl-N-methylglycyl-N-methyl-L-leucyl-L-valyl-N-methyl-L-leucyl-L-alanyl-D-alanyl-N-methyl-L-leucyl-N-methyl-L-leucyl-N-methyl-L-valyl] and it has the following structure:

Structural Formula

Formula: C ₆₂H ₁₁₁N ₁₁O ₁₂, Molecular weight: 1202.6

Cyclosporine is a white powder that is solubilized in perfluorobutylpentane, a semi-fluorinated alkane vehicle. VEVYE is supplied as a 2 mL sterile, clear, colorless, non-aqueous ophthalmic solution for topical ophthalmic use. VEVYE ^®contains:

• Active: cyclosporine 0.1%
• Inactives: perfluorobutylpentane, ethanol (anhydrous).

The solution does not contain water or anti-microbial preservatives. As a water free product, there is no associated pH and no osmolarity.

Safety and effectiveness in pediatric patients below the age of 18 years have not been established.

No overall difference in safety or effectiveness has been observed between elderly and younger patients.

The safety and efficacy of VEVYE were assessed in a total of 1369 patients with dry eye disease, of which 738 received VEVYE.

In two multicenter, randomized, adequate and well-controlled clinical studies, patients with dry eye disease (CYS-002: NCT02617667 and CYS-004: NCT04523129), treated with VEVYE ^®were compared to patients treated with vehicle. At Day 29, there was a statistically significant higher percentage of eyes with increases of ≥ 10 mm from baseline in Schirmer wetting. This effect was seen in approximately 10% of VEVYE-treated patients versus approximately 6% of vehicle-treated patients.

None.

The most common adverse reaction following the use of VEVYE were instillation site reactions (8%). ( 6.1)

To report SUSPECTED ADVERSE REACTIONS, contact

Harrow at 1-833-4HARROW(427769) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

Following bilateral topical ocular dosing of one drop of VEVYE twice daily, the blood concentrations of cyclosporine were below the limit of quantification (0.1 ng/mL) at all timepoints.

Instill one drop of VEVYE twice a day in each eye approximately 12 hours apart.

VEVYE indicated for the treatment of the signs and symptoms of dry eye disease.

Cyclosporine, a calcineurin inhibitor, is a relatively selective immunomodulatory drug.

Care should be taken to not touch the eye or other surfaces with the bottle tip to avoid potential for eye injury and/or contamination. ( 5.1)

Instill one drop of VEVYE twice a day in each eye approximately 12 hours apart. ( 2)

VEVYE should not be administered while wearing contact lenses. If contact lenses are worn, they should be removed prior to administration of the solution. Lenses may be reinserted 15 minutes following administration of VEVYE ophthalmic solution.

Clear, colorless non-preserved ophthalmic solution containing cyclosporine 0.1% (1 mg/mL), delivering 0.01 mg of cyclosporine per one drop (0.01 mL).

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In clinical trials with 738 subjects receiving at least 1 dose of VEVYE, the most common adverse reactions were instillation site reactions (8%) and temporary decreases in visual acuity (3%).

Wash hands before using.

Gently pull the lower eyelid downward. Tip the bottle upside down over the eye to allow one drop to dispense on its own into the eye. If a drop does not dispense after a few seconds, gently apply slight pressure to the sides of the bottle while holding over the eye.

Note:You may not feel the drop falling into your eye.

If VEVYE is used with other eye drops, a 15-minute interval between products should occur.

Advise patients to read the FDA-approved patient labeling (Instructions for Use).

VEVYE is a sterile, clear, colorless non-aqueous ophthalmic solution packaged in multiple-dose eye drop bottles delivering single drops of approximately 0.01 mL volume. Each unit contains 2 mL of VEVYE in a 5 mL transparent squeezable polypropylene bottle with a transparent polyethylene tip and a white polyethylene cap with tamper-evident ring.

NDC 82667-900-02

To avoid the potential for eye injury and/or contamination, patients should not touch the bottle tip to the eye or other surfaces.