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ROCKLATAN(netarsudil and latanoprost ophthalmic solution)0.02%/0.005%, for topical ophthalmic(六)
KLATAN dosed once daily to individually administered netarsudil0.02% once daily and latanoprost 0.005% once daily. The treatment duration was 12 months forStudy 301 and 3 months for Study 302.
The average IOP lowering effect of ROCKLATAN was 1 to 3 mmHg greater than monotherapy witheither netarsudil 0.02% or latanoprost 0.005% throughout 3 months (Figures 1 and 2). In Study 301 IOPreductions were maintained throughout 12 months.
Figure 1: Study 301 Mean IOP (mmHg) by Treatment Group and Treatment Difference in Mean IOP
Rocklatan vs.
Netarsudil
95% CI
3.0
(2.5, 3.6)
3.0
(2.4, 3.6)
2.4
(1.9, 3.0)
3.2
(2.6, 3.8)
2.9
(2.3, 3.5)
2.3
(1.7, 2.8)
3.1
(2.5, 3.8)
3.2
(2.5, 3.8)
2.0
(1.4, 2.6)
Rocklatan vs.
Latanoprost
95% CI
2.3
(1.7, 2.8)
2.6
(2.0, 3.2)
2.3
(1.8, 2.9)
1.7
(1.1, 2.4)
1.9
(1.3, 2.5)
1.7
(1.1, 2.2)
1.5
(0.9, 2.1)
1.7
(1.1, 2.3)
1.3
(0.7, 1.9)
The least square mean IOP at each post-baseline time point was derived using an analysis of covariance adjusted for baseline IOP and based on observed data for all
randomized subjects (238 in Rocklatan group, 244 in netarsudil group, 236 in latanoprost group).
Figure 2: Study 302 Mean IOP (mmHg) by Treatment Group and Treatment Difference in Mean IOP
Rocklatan vs.
Netarsudil
95% CI
3.4
(2.8, 3.9)
2.7
(2.2, 3.2)
2.2
(1.7, 2.8)
3.2
(2.6, 3.8)
2.9
(2.3, 3.4)
2.3
(1.8, 2.9)
3.6
(3.0, 4.2)
2.8
(2.3, 3.4)
2.4
(1.9, 2.9)
Rocklatan vs.
Latanoprost
95% CI
2.0
(1.5, 2.6)
2.4
(1.9, 2.9)
1.9
(1.3, 2.4)
1.5
(0.9, 2.1)
1.9
(1.3, 2.4)
1.6
(1.0, 2.1)
1.5
(0.9, 2.2)
2.0
(1.4, 2.5)
1.5
(1.0, 2.1)
The least square mean IOP at each post-baseline time point was derived using an analysis of covariance adjusted for baseline IOP and based on observed data for all
randomized subjects (245 in Rocklatan group, 255 in netarsudil group, 250 in latanoprost group).
16. HOW SUPPLIED/STORAGE AND HANDLING
ROCKLATAN (netarsudil and latanoprost ophthalmic solution) 0.02%/0.005% is supplied sterile in clearlow density polyethylene bottles with opaque white polyethylene dropper tips and white polypropylenescrew caps.
2.5 mL fill in a 4 mL container - NDC # 70727-529-25
Storage: Protect from light. Store at 2°C to 8°C (36°F to 46°F). During shipment, the bottle may bemaintained at temperatures up to 40°C (104°F) for a period not exceeding 14 days. After opening,ROCKLATAN can be used until the expiration date on the bottle.
17. PATIENT COUNSELING INFORMATION
Potential for Pigmentation
Advise patients about the potential for increased brown pigmentation of the iris, which may be permanent.
Inform patients about the possibility of eyelid skin darkening, which may be reversible afterdiscontinuation of ROCKLATAN [see Warnings and Precautions (5.1)].
Potential for Eyelash Changes
Inform patients of the possibility of eyelash and vellus hair changes in the treated eye during treatmentwith ROCKLATAN. These changes may result in a disparity between eyes in length, thickness,pigmentation, number of eyelashes or vellus hairs, and/or direction of eyelash growth. Eyelash changesare usually reversible upon discontinuation of treatment.
Handling the Container
Instruct patients to avoid allowing the tip of the dispensing container to contact the eye, surroundingstructures, fingers, or any other surface in order to minimize contamination of the |
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