Integrated Safety and Efficacy Analysis of FMX103 1.5% Topical Minocycline Foam for the Treatment 
of Moderate-to-Severe Papulopustular Rosacea: Results From Two Phase 3 Studies

James Q. Del Rosso, DO1; Linda Stein Gold, MD2; Leon Kircik, MD3; Neal D. Bhatia, MD4; Neil Sadick, MD5; Matthew Zirwas, MD6; Edward Lain, MD7; Iain Stuart, PhD8
 1JDR Dermatology Research/Thomas Dermatology, Las Vegas, NV; 2 Henry Ford Health System, Detroit, MI; 3Icahn School of Medicine at Mount Sinai, New York, NY; 4Therapeutics Clinical Research, San Diego, CA; 5Sadick Dermatology, New York, NY; 6Dermatologists of the Central States, Columbus, OH; 7Sanova Dermatology, Austin, TX; 8VYNE Therapeutics Inc., Bridgewater, NJ

Introduction
• Rosacea is a common, chronic, inflammatory cutaneous disorder involving the face that affects approximately 

16 million individuals in the United States1,2

• Rosacea is typically characterized by cutaneous signs such as flushing, erythema, edema, papules, and pustules1-5

• Topical therapies such as metronidazole, azelaic acid, and ivermectin are considered first-line therapies for 
papulopustular rosacea2-5

 – Oral tetracyclines, specifically doxycycline and minocycline, are mainstays of treatment for moderate-to-
severe disease; however, they have the potential for significant systemic side effects2,4

 – Independent of their antimicrobial activity, tetracyclines may exert beneficial effects in rosacea due, in part, to 
their anti-inflammatory, antiapoptotic, and antiangiogenic activities6

• FMX103 1.5% is a topical minocycline foam being developed for the treatment of moderate-to-severe 
papulopustular rosacea7,8

 – The efficacy, safety, and tolerability of FMX103 1.5% from two identical, Phase 3, randomized, double-blind, 
vehicle-controlled studies, FX2016-11 (Study 11) and FX2016-12 (Study 12), have previously been presented8

• Objective: To compare integrated efficacy and safety of FMX103 1.5% vs vehicle administered daily for 
12 weeks

Methods
• The 2 pivotal Phase 3 studies (FX2016-11, Study 11; FX2016-12, Study 12) were randomized, double-blind 

comparisons of FMX103 1.5% with vehicle foam (Figure 1)
• Qualified subjects were enrolled and randomly assigned in a 2:1 ratio to receive either FMX103 1.5% or vehicle
• Subjects applied the assigned study drug once daily for 12 weeks and returned for visits at Weeks 2, 4, 8, and 12
• The efficacy data from Studies 11 and 12 were pooled for analysis both in totality and for the predefined subgroup 

of baseline disease severity (moderate, IGA=3; severe, IGA=4)
• Safety endpoints included adverse events and local facial tolerability assessments, which were summarized for the 

overall pooled population, as well as for predefined subgroups including sex, race, age, and baseline disease severity

Figure 1. Study design

Week 12Baseline

Key Inclusion Criteria
• Males and nonpregnant females ≥18 years
• Moderate-to-severe facial papulopustular rosacea (IGA score of 3 or 4) 
• >15 to ≤75 facial papules and pustules, excluding lesions involving

eyes and scalp; ≤2 nodules on the face 
• Presence or history of facial erythema or flushing

Integrated efficacy populationa (N=1522)

Vehicle Foam (n=513)

FMX103 1.5% (n=1009)

Study 11, n=256
Study 12, n=257

Study 11, n=495
Study 12, n=514

•
•

Co-Primary Efficacy Endpoints
Absolute change in the inflammatory lesion count at week 12 compared to baseline
IGA Success Rate (dichotomized as yes/no) at week 12, where success was
defined as an IGA score of 0 or 1, and at least a 2-grade improvement (decrease)
from baseline

Week 4 Week 8

aThe integrated efficacy population consisted of all randomized subjects that were pooled from Studies 11 (n=751) and 12 (n=771). One subject was randomized but discontinued prior to taking the first dose and was therefore not 
included in the integrated safety population.

IGA, Investigator’s Global Assessment; based upon a 5-point scale with 0=clear, 1=almost clear, 2=mild, 3=moderate, and 4=severe.

Results
Baseline Demographics and Disease Characteristics
• 1522 subjects were included in the integrated efficacy population
• Baseline demographics and disease characteristics are shown in Table 1
• The majority of subjects were female (70.6%) and white (96.4%). The mean age was 50.0 and ranged from 18-86 

years. At baseline, 86.9% and 13.1% of subjects had moderate (IGA=3) or severe (IGA=4) disease, respectively
• Baseline demographics and disease characteristics were similar across treatment groups

Table 1. Baseline demographics and disease characteristics

Variable FMX103 1.5%(n=1009)
Vehicle Foam 

(n=513)
Overall

(N=1522)
Mean age (SD) 49.9 (13.84) 50.3 (13.17) 50 (13.61)

18 to 40 years, n (%) 265 (26.3) 118 (23.0) 383 (25.2)
41 to 64 years, n (%) 588 (58.3) 311 (60.6) 899 (59.1)
65 years, n (%) 156 (15.5) 84 (16.4) 240 (15.8)

Sex, m (%)
Male 289 (28.6) 159 (31.0) 448 (29.4)
Female 720 (71.4) 354 (69.0) 1074 (70.6)

Race
White 973 (96.5) 491 (96.1) 1464 (96.4)
Black 14 (1.4) 5 (1.0) 19 (1.3)
Other 21 (2.1) 15 (2.9) 36 (2.4)

Mean inflammatory lesion count, n (SD) 29.2 (12.48) 29.6 (12.57) 29.4 (12.5)
IGA score, n (%)

3 – Moderate 887 (87.9) 435 (84.8) 1322 (86.9)
4 – Severe 122 (12.1) 78 (15.2) 200 (13.1)

IGA, Investigator’s Global Assessment; SD, standard deviation.
Note that percentages exclude missing values.

Pooled Efficacy Data
• In the combined analysis of the two pivotal Phase 3 studies, FMX103 1.5% demonstrated statistically significant 

benefit compared to vehicle foam for both co-primary endpoints (Figure 2)
 – At week 12, FMX103 1.5% demonstrated a significantly greater reduction from baseline in inflammatory 

lesions than vehicle foam (Figure 2A)
 – A significantly greater number of subjects receiving FMX103 1.5% achieved IGA treatment success at week 12 

than those receiving vehicle foam (Figure 2B)

Figure 2. Co-primary efficacy endpoints

%
 IG

A
 s

uc
ce

ss
 a

t w
ee

k 
12

R
ed

uc
tio

n 
fr

om
 b

as
el

in
e 

at
 w

ee
k 

12
in

 in
fla

m
m

at
or

y 
le

si
on

s 
(L

S
M

ea
n)

BA

-20

-16

-12

-8

-4

-18

-14

-10

-6

0
-2

-18.0

n=1009

FMX103 1.5%

-14.9

n=513

Vehicle Foam

P<0.001, LSM Diff: 3.0
LSM Diff 95% CI: 1.92, 4.16

0

20

40

60

10

30

50

FMX103 1.5%

n=1009

50.6%

Vehicle Foam

n=513

41.0%

P<0.001
RR: 1.24; 95% CI: 1.095, 1.394

IGA, Investigator’s Global Assessment; LSM Diff, LSMean Difference; CI, Confidence Interval; RR, risk ratio.
Integrated efficacy population (multiple imputation).

• FMX103 1.5% demonstrated a statistically significant advantage over vehicle foam for inflammatory lesions 
beginning as early as week 4 (Figure 3)

 – The FMX103 1.5% group exhibited a significantly greater reduction in inflammatory lesions at week 4 than the 
vehicle foam group

 – This statistically significant advantage over vehicle was maintained at weeks 8 and 12

Figure 3. Change from baseline in inflammatory lesion counts by visit

R
ed

u
ct

io
n

 f
ro

m
 b

as
el

in
e 

at
 w

ee
k 

12
in

 in
fl

am
m

at
o

ry
 le

si
o

n
s 

(L
S

M
 d

if
f)

-25

-20

-15

-10

-5

0
0 4 8 12

FMX103 1.5% n=1009
Vehicle Foam, n=513

Week

Integrated efficacy population (multiple imputation); LSM diff, least squares mean difference

• FMX103 1.5% demonstrated a statistically significant advantage over vehicle foam for IGA treatment success 
beginning as early as week 4 (Figure 4) 

 – This statistical advantage over vehicle was maintained throughout the study, with approximately half of the subjects 
in the FMX103 1.5% group achieving treatment success by week 12

Figure 4. IGA treatment success over time

%
 IG

A
 tr

ea
tm

en
t s

uc
ce

ss

0

50

25

75

Week

4 128

FMX103 1.5% (n=1009) Vehicle Foam (n=513)

16.0

9.4

37.8

30.0

50.6

41.0

P=0.001

P=0.003

P<0.001

IGA, Investigator’s Global Assessment; Integrated efficacy population (multiple imputation); P values are based on common risk ratios.

Efficacy Results In The Patient Subgroups Scored As Moderate Or Severe  
At Baseline
• FMX103 1.5% demonstrated statistically significant advantages over vehicle foam in both baseline disease 

severity subgroups (Figure 5)
 – In both moderate (IGA=3) and severe (IGA=4) subpopulations, the change from baseline at week 12 in 

inflammatory lesions was significantly greater in the FMX103 1.5% group than in the vehicle foam group 
(Figure 5A)

 – Similarly, a significantly greater number of subjects in the FMX103 1.5% group achieved IGA treatment 
success by week 12 than in the vehicle foam group, regardless of baseline disease severity (Figure 5B)

 – The treatment effect for FMX103 1.5% vs vehicle foam was more pronounced in the severe subgroup than in 
the moderate subgroup for both inflammatory lesions (Figure 5A) and IGA treatment success (Figure 5B)

Figure 5. Efficacy of FMX103 1.5% across baseline disease severities

R
ed

uc
tio

n 
fr

om
 b

as
el

in
e 

at
 w

ee
k 

12
in

 in
fla

m
m

at
or

y 
le

si
on

s 
(L

S
M

ea
n)

A

-30

-20

-10

-25

-15

0

-5

-18.0

1009

Overall

Baseline lesion counta:

513

-14.9
-16.7

887

Moderate
(IGA=3)

435

-14.6

-26.0

122

Severe
(IGA=4)

78

27.1 27.2 44.9 43.3

-15.1

P<0.001
P<0.001

P<0.001

%
 IG

A
 tr

ea
tm

en
t s

uc
ce

ss
 a

t w
ee

k 
12

B

0

20

40

10

30

60

50
50.6%

1009

Overall

513

41.0%

52.5%

887

Moderate
 (IGA=3)

435

45.7%

36.8%

122

Severe
 (IGA=4)

78

14.9%

P<0.001 P=0.01

P=0.003

n=

n=

FMX103 1.5% Vehicle Foam

IGA, Investigator’s Global Assessment; Integrated efficacy population (multiple imputation); aBaseline lesion counts are based on observed cases.

Safety Endpoints
• Overall summary of Adverse Events is shown in Table 2
• All serious TEAEs were considered by the investigators as not related to study drug
• 9 subjects reported 10 TEAEs resulting in study discontinuation

 – 7 subjects in the FMX103 1.5% group and 2 subjects in the vehicle group
 – One TEAE (moderate pruritis) leading to drug withdrawal was considered related to study drug. The subject 

was randomized to FMX103 1.5% treatment

Table 2. Summary of TEAEs and AEs in the integrated safety population
FMX103 1.5%

(n=1008)
Vehicle Foam 

(n=513)
Overall

(N=1521)
Subjects with any AE, n(%) 232 (23) 129 (25.1) 361 (23.7)

Number of AEs 380 200 580
Subjects with any TEAE, n(%) 219 (21.7) 122 (23.8) 341 (22.4)

Number of TEAEs 350 184 534
Subjects with any serious TEAE, n(%) 3 (0.3) 5 (1.0) 8 (0.5)

Number of serious TEAEs 8a 9b 17
Subjects with any treatment-related TEAE, n(%) 3 (0.3) 5 (1.0) 8 (0.5)

Number of treatment-related TEAEs 24c 17d 41
Subjects with any TEAE leading to discontinuation, n(%) 7 (0.7) 2 (0.4) 9 (0.6)

Number of TEAEs leading to study discontinuation 8e 2f 10
aNausea, chest discomfort, fatigue, seasonal allergy, dehydration, syncope, dyspnea, hypertension
bGastrointestinal hemorrhage, chest pain, pyrexia, dyspnea, asthma, hypertension, myocardial infarction, tachycardia
cPruritis, rash, dermatitis, dermatitis contact, hair color changes, nail discoloration, skin hyperpigmentation, application site pain, application site erythema, facial pain, nodule, migraine, dizziness, dysgeusia, aphthous ulcer, cheilitis, 
eye irritation, ophthalmic herpes simplex, sunburn

dNail discoloration, rosacea, skin exfoliation, application site pain, facial pain, application site pruritis, headache, cellulitis, skin cancer, urine odor abnormal
ePruritis, dermal cyst, dermatitis, telangiectasia, influenza, urinary tract infection, bladder mass
fRash pustular, myocardial infarction

• The incidence rate of the most frequently reported TEAEs (≥1% in any group) was similar between treatment 
groups (Table 3)

• Overall, most subjects reported TEAEs that were not related to study drug (89.7%, 306/341)

Table 3. Summary of non-cutaneous TEAEs in the integrated safety population by 
preferred term (≥1% in any group)

TEAEs in ≥1% of subjects in either group, n (%) FMX103 1.5%(n=1008)
Vehicle Foam 

(n=513)
Overall

(N=1521)
Viral upper respiratory tract infection 24 (2.4) 12 (2.3) 36 (2.4)
Upper respiratory tract infection 19 (1.9) 13 (2.5) 32 (2.1)
Headache 14 (1.4) 10 (1.9)a 24 (1.6)
Sinusitis 11 (1.1) 2 (0.4) 13 (0.9)
Diarrhea 10 (1.0) 2 (0.4) 12 (0.8)

a2 cases were considered to be treatment-related

• The incidence rate of TEAEs by severity was similar between treatment groups (Table 4)
• Overall, most subjects reported TEAEs that were mild (68.0%, 232/341) or moderate (29.9%, 102/341) in severity
• 7 subjects (2.1%, 7/341) reported severe TEAEs 
• All severe TEAEs were considered not related to the study medication by the investigator

Table 4. Summary of TEAEs by severity 

FMX103 1.5% (n=1008) Vehicle Foam (n=513) Overall (N=1521)

OA Mild Mod Sevr OA Mild Mod Sevr OA Mild Mod Sevr

Subjects 
reporting any 
TEAE, n (%)a

219
(21.7)

145 
(14.4)

71
(7.0)

3b
(0.3)

122
(23.8)

87
(17.0)

31
(6.0)

4c
(0.8)

341
(22.4)

232
(15.3)

102
(6.7)

7
(0.5)

Mod, moderate; OA, overall; Sevr, severe.
aSubjects experiencing one or more adverse events are counted only once for each adverse event term and counted only by the maximum severity. If severity is missing, it is counted as Severe.
bRosacea, post-traumatic headache, application site pain.
cFall, dyspnea, asthma, pyrexia, myocardial infarction.

• Similar incidence rates of TEAEs were observed across both treatment groups for predefined subgroups (Figure 6):
 – Sex
 – Race
 – Age
 – Baseline disease severity (IGA)

Figure 6. Summary of overall percentages of AEs in all groups

0

15

45

50

A
dv

er
se

 e
ve

nt
s,

 %

Sex

FMX103 1.5% Vehicle Foam

5

10

20

25

30

35

40

Race Age Baseline IGA
severity

Female Male White Non-White 18-40 years 41-64 years ≥65 years IGA 3 IGA 4

22.9
25.7

18.7 19.5
21.5

23.4

27.8
31.8

18.5

26.3

22.3 22.2
25.2

26.2

23.0
21.821.6

24.1

• The majority of subjects in both treatment groups recorded local tolerability assessments as none or mild at both 
baseline and week 12 (Figure 7)

 – Similar rates of mild, moderate, and severe assessments were observed across both treatments and 
timepoints within each subgroup category

 – No notable differences were observed in facial tolerability assessments by subgroup
 – At week 12, all facial local tolerability assessments showed improvement compared to baseline
 – Notable improvements in erythema were observed, with the percentage of patients with clear or almost clear 

signs of erythema increasing from 6.1% at baseline to 44.8% at week 12

Figure 7. Facial local tolerability assessments at baseline and week 12 in FMX103 1.5% 
treatment group

BL Wk 52

Erythema

BL Wk 12 BL Wk 12 BL Wk 12 BL Wk 12 BL Wk 12 BL Wk 12 BL Wk 12
Hyper-

pigmentation
Peeling/

Desquamation
ItchingDryness/

Xerosis
Flushing/
Blushing

Burning/
Stinging

Telangiectasia

10.55.1

34.3

28.9

36.2

63.8

18.3

0.7

Clear

Severe

Moderate

Mild

Almost Clear

None Mild Moderate Severe

1.3

1.0
12.5

20.2

52.3

83.9

17.1

50.5
37.4

72.0

44.2

76.7

57.2

81.9

64.9
74.754.8

61.0

27.6

13.3

38.7

39.0

36.8

23.9

35.0

20.0

31.5

16.1

28.3
22.532.6

18.8 19.8

2.8

40.3

9.6

25.2

4.0

20.1

3.3
11.0

1.9 6.8 2.8
0.1 0.0 0.3 0.0 4.0 0.9 0.6 0.1 0.6 0.0 0.2 0.1 0.0 0.0

0%

25%

50%

100%

75%

S
ub

je
ct

s 
w

ith
 lo

ca
l s

ig
ns

 o
r 

sy
m

pt
om

s,
 %

BL=baseline, N=1008; Wk 12=week 12, N=897; All symptoms were evaluated on a 4-point scale consisting of 0=none, 1=mild, 2=moderate, and 3=severe, except for erythema, which was evaluated on a 5-point scale 
consisting of 0=clear, 1=almost clear, 2=mild, 3=moderate, and 4=severe.

Summary
Efficacy Summary
• FMX103 1.5% demonstrated efficacy over vehicle foam in treating papulopustular rosacea in a pooled population 

of ~1500 subjects, with effects being observed as early as 4 weeks into treatment
• Sub-analyses were performed on the integrated data set to characterize the efficacy of FMX103 1.5% in treating 

papulopustular rosacea in predefined subgroups of subjects
 – FMX103 1.5% demonstrated significant efficacy benefits in treating papulopustular rosacea in subgroups 

of subjects that had either moderate (IGA=3) or severe (IGA=4) disease severity at baseline, with a more 
pronounced effect in the severe subpopulation 

• Findings from this integrated efficacy analysis are thus consistent with those from the individual phase 3 
studies, both of which achieved statistically significant differences for all primary efficacy endpoints and further 
demonstrated significant differences as early as 4 weeks into treatment

Safety Summary
• FMX103 1.5% was generally safe and well tolerated
• 341 (22.4%) subjects reported a TEAE during the 2 identical double-blind Phase 3 studies

 – In general, no differences were observed between treatment groups in the incidence of TEAEs
 – The most frequently reported TEAEs for FMX103 1.5% vs vehicle, respectively, were viral upper respiratory 

tract infection (2.4% vs 2.3%), upper respiratory tract infection (1.9% vs 2.5%), and headache (1.4% vs 1.9%) 
 – The majority of TEAEs reported were mild in severity (overall 68%)
 – 7 subjects reported severe TEAEs; all were considered to be unrelated to treatment, and were similar 

between treatment groups
• TEAEs were similar across clinically relevant subgroups, including sex, race, age, and baseline IGA score
• At week 12, all facial tolerability assessments had higher percentages of “none” compared to baseline and 

trended towards improving scores in the FMX103 1.5% treatment group

Limitations
• A limitation of these studies relates to the generalizability of the data to a more ethnically diverse population, or to 

patients not conforming to the inclusion criteria of the studies
• An inclusionary criterion was to avoid common rosacea triggers, so efficacy would not be affected by such triggers

Conclusions
• FMX103 1.5% demonstrated statistically significant differences compared with vehicle for both co-primary 

endpoints in a pooled population of two Phase 3 studies, and numerical advantages across clinically relevant 
subpopulations

• The results of the pooled safety analysis of 1,521 patients from two identical phase 3 studies demonstrated 
that FMX103 1.5% topical minocycline foam appeared to be safe and well tolerated with no serious treatment-
related adverse events when administered daily for 12 weeks for the treatment of moderate-to-severe facial 
papulopustular rosacea

Disclosures/Acknowledgment
Disclosures 
Dr. Del Rosso is a consultant for Aclaris, Almirall, Athenex, Cutanea, Dermira, Ferndale, Galderma, Genentech, LEO Pharma, Menlo, Novan, Ortho, Pfizer, Promius, Sanofi/Regeneron, 
SkinFix, and SunPharma; he has received research support from Aclaris, Almirall, Athenex, Botanix, Celgene, Cutanea, Dermira, Galderma, Genentech, LEO Pharma, Menlo, Novan, Ortho, 
Promius, Regeneron, SunPharma, and Thync; he receives honoraria from Aclaris, Celgene, Galderma, Genentech, LEO Pharma, Novartis, Ortho, Pfizer, Promius, Sanofi/Regeneron, and 
SunPharma; and he participates in speakers bureaus for honoraria from Aclaris, Celgene, Galderma, Genentech, LEO Pharma, Novartis, Ortho, Pfizer, Promius, Sanofi/Regeneron, and 
SunPharma. Dr. Stein Gold is an advisor and investigator for Foamix Pharmaceuticals Inc, Galderma, LEO Pharma, Novartis, and Valeant and is an investigator for Janssen, AbbVie, and 
Solgel. Dr. Kircik is an investigator and consultant for Foamix Pharmaceuticals. Dr. Bhatia is an investigator and consultant for Foamix Pharmaceuticals. Dr. Sadick is a consultant for Almirall, 
Galderma USA, Venus Concept, Allergan, Inc., Auxilium Pharmaceuticals, Inc., BTG PLC, Cynosure, Inc., Endo International plc, Eternogen, Ferndale Loboratories, Inc., Gerson Lehrman 
Group, Merz Aesthetics, Valeant Pharmaceticals International; an advisor for Slender Medical Ltd., Galderma Laboratories, L.P., Merz Aesthetics, Suneva Medical, Inc., a stockholder in 
Vascular Insights, LLC; a principal investigator for Actavis, Anacor Pharmaceuticals, Inc., Bayer, Biorasi, LLC, Cassiopea SpA, Celgene Corporation, Cynosure, Inc., DUSA Pharmaceuticals, 
Inc., Eli Lilly and Company, Endo International plc, Galderma USA, Hydropeptide, LLC, Neostrata, Novartis, Nutraceutical Wellness, LLC., Palomar Medical Technologies, Roche Laboratories, 
Samumed, LLC, Valeant Pharmaceuticals International, Vanda Pharmaceuticals; a  speaker for Celgene Corporation, Cutera, Inc., EndyMed Medical Inc. USA, Solta Medical, Storz Medical 
AG, and Venus Concept. Dr. Zirwas is a consultant for Regeneron/Sanofi, Fit Bit, L’Oreal, Menlo, Leo, Lilly, Ortho Derm, Arcutis; an investigator for Regeneron/Sanofi, Leo, Janssen, Incyte, 
Foamix, UCB, Pfizer, Lilly, Asana, Avillion, Abbvie, Edessa Biotech, Galderma, Dermavant, Arcutis; a speaker for Regeneron/Sanofi, Genench/Novartis and part owner of AsepticMD. 
Dr. Lain is an advisor, speaker, and investigator for Foamix Pharmaceuticals. Dr. Stuart is an employee and stockholder at VYNE Therapeutics Inc.

Acknowledgment
Editorial support was provided by Scient Healthcare Communications.

Funding
This study is funded by Foamix Pharmaceuticals Ltd, a wholly owned subsidiary of VYNE Therapeutics Inc.

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