Tryptyr Drug Information
Generic name: ACOLTREMON
TRPM8 Thermoreceptor Agonist [EPC]
Uses of Tryptyr
is indicated for the treatment of the signs and symptoms of dry eye disease. TRYPTYR is a TRPM8 thermoreceptor agonist indicated for the treatment of the signs and symptoms of dry eye disease.
Dosage & Administration of Tryptyr
Recommended Dosage Instill one drop in each eye twice daily (approximately 12
hours apart).
Administration Instructions Wash hands before use.
The single-dose vials are to be used immediately after opening and can be used to dose both eyes. Discard the single-dose vial, including any remaining contents, immediately after use. TRYPTYR can be used concomitantly with other topical ophthalmic eye drops.
If more than one topical ophthalmic drug is being used, the drugs should be administered at least five minutes apart. Contact lenses should be removed prior to the administration of TRYPTYR and may be reinserted 15 minutes following administration. If one dose is missed, treatment should continue with the next dose.
Side Effects of Tryptyr
Clinical Trials Experience
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 patients with dry eye disease, 766 patients received at least one dose of TRYPTYR in four randomized controlled clinical trials across 71 sites in the United States. The most common ocular adverse reaction observed in controlled clinical studies with TRYPTYR was instillation site pain (50%). Less than 1% of patients discontinued therapy due to burning or stinging sensation in the eyes.
Warnings & Cautions for Tryptyr
Potential for Eye Injury and Contamination To avoid the potential for eye
injury and contamination, do not touch the vial tip to the eye or other surfaces.
Use with Contact Lenses
TRYPTYR 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 TRYPTYR.
Pregnancy Safety for Tryptyr
Pregnancy Risk Summary There are no adequate and well-controlled studies on TRYPTYR in pregnant women. Systemic exposure to acoltremon from ocular administration is negligible . Intravenous administration of acoltremon to pregnant rats and rabbits during organogenesis did not produce embryofetal toxicity at 806- and 2151-fold the maximum recommended human ocular dose (MRHOD) of acoltremon on a mg/m 2 basis ( see Data ). All pregnancies have a risk of birth defect, loss, or other adverse outcomes. In the US general population, the estimated background risk of major birth defects is 2 to 4%, and of miscarriage is 15 to 20%, of clinically recognized pregnancies.
Data Animal Data In embryofetal developmental studies in pregnant rats and rabbits dosed by intravenous injection daily during organogenesis from gestation days 6-17 and gestation days 7-19, respectively, no maternal or fetal toxicity was observed at 806- and 2151-fold the MRHOD of acoltremon on a mg/m 2 basis.
Pediatric Use of Tryptyr
Pediatric Use The safety and effectiveness of TRYPTYR have not been established in pediatric patients.
Clinical Studies of Tryptyr
The efficacy of TRYPTYR for the treatment of dry eye disease was supported by two randomized, multi-center, double-masked, vehicle-controlled studies (COMET-2 and COMET-3 ) enrolling a total of 931 dry eye patients (462 of which received TRYPTYR). Patients were randomized to TRYPTYR or vehicle (placebo) in a 1:1 ratio and dosed twice a day for 90 days. Use of artificial tears was not allowed during the studies. The mean age was 61 years (range, 30-93 years). The majority of patients were female (74.8%). Enrollment criteria included signs (i.e., corneal fluorescein staining score and anesthetized Schirmer tear test ) and symptoms (i.e., SANDE Score and Ocular Discomfort Score ) of dry eye disease.
Efficacy Tear film production was measured by unanesthetized Schirmer tear test assessed using a Schirmer strip (0 - 35 mm). The average baseline unanesthetized Schirmer scores for TRYPTYR and Vehicle treated patients was 6.2 mm and 5.9 mm in the COMET-2 study, and 6.8 mm and 6.4 mm in the COMET-3 study, respectively. Of the patients treated at Day 14 (primary endpoint) with TRYPTYR, 42.6% achieved ≥ 10 mm increase in Schirmer score from baseline in the COMET-2 study and 53.2% achieved ≥ 10 mm increase in Schirmer score from baseline at Day 14 in the COMET-3 study, compared to 8.2% and 14.4% of vehicle-treated patients in the COMET-2 study and the COMET-3 study, respectively. A statistically significant improvement in tear production favoring TRYPTYR (p<0.01) was observed in both studies ( Table 1 ). Table 1: Percent of Patients Achieving ≥ 10 mm Improvement from Baseline in Schirmer Score at Day 14 in Patients with Dry Eye Disease Tear Production COMET-2 COMET-3 TRYPTYR N = 230 Vehicle N = 235 TRYPTYR N = 232 Vehicle N = 234 ≥ 10 mm increase in tear production at Day 14 42.6% 8.2% 53.2% 14.4% Difference (95% CI) 34.4% 38.8% P-value versus vehicle < 0.01 < 0.01 Consistent results were observed at all timepoints through Day 90.
Drug information sourced from the FDA. This content is for informational purposes only and does not constitute medical advice. Consult a healthcare professional before making any medication decisions.
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