DURYSTA

After a single administration of DURYSTA, bimatoprost concentrations were below the lower limit of quantitation (0.001 ng/mL) in the majority (approximately 92%) of patients. The maximum bimatoprost concentration observed in any patient was 0.00224 ng/mL. Bimatoprost acid concentrations were also below the lower limit of quantitation (0.01 ng/mL) in almost all (approximately 99%) of patients.

Efficacy was evaluated in two multicenter, randomized, parallel-group, controlled 20-month (including 8-month extended follow-up) studies of DURYSTA compared to twice daily topical timolol 0.5% drops, in patients with OAG or OHT. DURYSTA demonstrated an IOP reduction of approximately 5-8 mmHg in patients with a mean baseline IOP of 24.5 mmHg (see Figures 3 and 4). Figure 3:

Study 1Mean IOP (mmHg) by Treatment Group and Treatment Difference in Mean IOP Figure 4:

Study 2Mean IOP (mmHg) by Treatment Group and Treatment Difference in Mean IOP Figure 3 Figure 4

The following clinically significant adverse reactions are described elsewhere in labeling: Implant migration [see Contraindications ( 4.4 )] Hypersensitivity [see Contraindications ( 4.5 ) ] Corneal adverse reactions [see Warnings and Precautions ( 5.1 ) ] Macular edema [see Warnings and Precautions ( 5.3 ) ] Intraocular inflammation [see Warnings and Precautions ( 5.4 ) ] Pigmentation [see Warnings and Precautions ( 5.5 ) ] Endophthalmitis [see Warnings and Precautions ( 5.6 ) ] In contr...

Ocular or periocular infections ( 4.1 ) Corneal endothelial cell dystrophy ( 4.2 ) Prior corneal transplantation ( 4.3 ) Absent or ruptured posterior lens capsule ( 4.4 ) Hypersensitivity ( 4.5 ) 4.1 Ocular or Periocular Infections DURYSTA is contraindicated in patients with active or suspected ocular or periocular infections. 4.2 Corneal Endothelial Cell Dystrophy DURYSTA is contraindicated in pa...

Endothelial cell loss : Due to possible corneal endothelial cell loss, administration of DURYSTA should be limited to a single implant per eye without retreatment. ( 5.1 ) Corneal Adverse Reactions : DURYSTA has been associated with corneal adverse reactions and risks are increased with multiple implants. Use caution in patients with limited corneal endothelial cell reserve. ( 5.1 ) Iridocorneal Angle : DURYSTA should be used with caution in patients with narrow angles or anatomical angle obstru...