Ocuphire Pharma Investor Day Presentation Deck
RM
57
MIRA-2: Safety Findings (After Dilation with Mydriatic Agent)
Nyxol was Well Tolerated with a Favorable Safety Profile
Total Treatment Emergent Adverse Events (n)
TEAES by Severity (n [%])
Mild
Moderate
Severe
AES Occurring in ≥ 5% of subjects (n [%])
Instillation Site Discomfort
Conjunctival Hyperemia
Conjunctival Hyperemia (mean [SD])
Baseline (-1 hour)
60 minutes after instillation of Nyxol
4 Hours after instillation of Nyxol
Conjunctival Hyperemia
Grading Scale (CCLRU)
None (0)
Nyxol
n=94
113
47 (50%)
3 (3%)
0 (0%)
36 (38%)
12 (13%)
0.7 (0.6)
1.7 (0.5)
1.2 (0.7)
Mild (+1)
Placebo
n=91
31
15 (17%)
0 (0%)
0 (0%)
8 (9%)
0 (0%)
0.7 (0.5)
0.5 (0.5)
0.5 (0.5)
Moderate (+2)
Total
n=185
144
62 (33%)
3 (2%)
0 (0%)
44 (24%)
12 (7%)
1 1 1
Severe (+3)
There were no deaths, serious
AES, or withdrawals due to AEs
94% of the AEs in the
Nyxol group were mild
Installation site discomfort was 97%
mild; No burning, no stinging, no
ptosis upon installation
From a baseline mean of 0.7, the
mean hyperemia score
increased by approximately 1.0
unit (on a 4-point scale) at 60
minutes post-dose and
decreased steadily thereafter
Source MIRA-2 Safety Population TLR table 14.3.1.1.; MIRA-2 table 14.3.1.2.2 System Organ Class; MIRA-2 table 14.3.3.2 Hyperemia Score by Time Point
Ocuphire
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