Efficacy and safety of a hyaluronic acid filler in subjects treated for correction of midface volume deficiency: a 24 month study

Figures & data

Figure 1 Study subjects with a pre-treatment MFVDS grade of 3, 4, and 5 respectively, as evaluated by the physician investigator.

Abbreviation: MFVDS, Midface Volume deficient Scale.

Table 1 Reasons for withdrawal from the study

Reason	n
Lost to follow-up	24
Protocol violation	2
Withdrew consent	2
Adverse event	1
Death	1

Figure 2 Study subject with a pre-treatment MFVDS grade of 4 who maintained a ≥1 grade improvement from baseline/pre-treatment state for the duration of the 104 week study after Voluma^™ treatment at weeks 0 and 4 only, as evaluated using the MFVDS (physician investigator assessment) and the GAIS (independent physician investigator and subject evaluations).

Abbreviations: GAIS, Global Aesthetic Improvement Scale; MFVDS, Midface Volume Deficit Scale.

Figure 3 (A) Proportion of subject with ≥1 point improvement from baseline in MFVDS score, (“MFVDS responder”) as evaluated by the physician investigators (all subjects). No subject received further study treatment after week 0 or 4. Numbers in parentheses are the sample size at each visit. (B) Proportion of responders from the sub-group of 45 subjects who completed the study and who received no further treatment with the study product after the week 0 or 4.

Abbreviation: MFVDS, Midface Volume Deficit Scale.

Table 2 Proportion of subjects with maintenance of a clinically meaningful correction of their midface volume deficiency during the study, based on physician MFVDS and physician and subject GAIS scoresa,b

	% responders (95% CI)
Outcome parameter (n)c	Week 8 99	Week 52 68	Week 78 82	Week 104 45d
MFVDS (physician investigator evaluation)	96.0 (90.0, 98.9)	88.2 (78.1, 94.8)	81.7 (71.6, 89.4)	95.6 (84.9, 99.5)
GAIS (physician investigator evaluation)	100 (96.3, 100)	88.2 (78.1, 94.8)	78.1 (67.5, 86.4)	91.1 (78.8, 97.5)
GAIS (subject evaluation)	98.0 (92.9, 99.8)	79.4 (67.9, 88.3)	73.2 (62.2, 82.4)	82.2 (68.0, 92.0)

Notes:^aImprovement of ≥1 grade from baseline score for each scale

b data presented for cohort of subjects who received no further treatment with the study product after the week 0 or 4 clinic visit

c number of subjects evaluated at each clinic visit

d In comparison, the responder rate for all 72 patients attending this visit, including those retreated at week 78 (n = 27) was: MFVDS: 91.7%, GAIS (physician investigator evaluation): 90.3%, GAIS (subject’s evaluation): 86.1%.

Abbreviations: CI, confidence interval; GAIS, global aesthetic improvement scale; MFVDS, Midface Volume Deficit Scale.

Figure 4 (A) Proportion of subjects with ≥1 point improvement in their pre-treatment appearance based on GAIS (“GAIS responder”), as evaluated by the physician investigators. No subject received further study treatment after week 0 or 4. Numbers in parentheses are the sample size at each visit. (B) Proportion of subjects from the subgroup of 45 who completed the study and who received no further treatment after week 0 or 4 with ≥1 point improvement in their pre-treatment appearance, based on the GAIS (“GAIS responder”) at week 104, as evaluated by the physician investigators.

Abbreviation: GAIS, Global Aesthetic Improvement Scale.

Figure 5 (A) Proportion of subjects with ≥1 point improvement in their pre-treatment appearance based on GAIS (“GAIS responder”), as evaluated by the subjects. No subject received further study treatment after week 0 or 4. Numbers in parentheses are the sample size at each visit. (B) Proportion of subjects from the sub-group of 45 who completed the study and who received no further treatment after week 0 or with a ≥1 point improvement in their pre-treatment appearance, based on the GAIS (“GAIS responder”) at week 104, as self-evaluated by the subjects.

Abbreviation: GAIS, Global Aesthetic Improvement Scale.

Figure 6 Treatment Satisfaction of the Study Subjects (all observed subjects).

Figure 7 Study Treatment Recommendation.

Note: Study Subject’s response to the following question: “Would you recommend Voluma^™to others”? (all observed subjects).

Table 3 Incidence of injection site reactions following the two observational periods (weeks 0–8 and weeks 78–108)

Event	n (%)a	n (%)b
	Weeks 0–8	Weeks 78–108
Bruisingc	42 (40.8)	2 (1.9)
Swelling	15 (14.6)	5 (4.9)
Pain/tenderness	8 (7.8)	1 (1.0)
Erythema	2 (1.9)	0 (0)
Eyelid edema	1 (1.0)	0 (0)
Vasovagal syncope	1 (1.0)	0 (0)

Notes:^aFrequency of adverse events reported during the period: week 0–8 in 103 subjects receiving the study treatment at week 0

b frequency of adverse events reported during the period: week 78–108 following re-retreatment with the study product in eligible subjects at either week 78 or week 104. Subjects receiving the study treatment at week 104 were followed for a total of 4 weeks post-treatment for safety and tolerability. New adverse events reported between weeks 8 and 78 were documented in the second observational period

c includes lump/hematoma.