Clinical Hypothesis. The clinical hypothesis of this study is that a significant proportion of subjects treated with Juvéderm® VOLIFT™ with Lidocaine will achieve at least a 1-point improvement in the 5- point Lip Fullness Scale (LFS2) at 30 days post last treatment. Additionally, subjects will have a significantly higher satisfaction with lip appearance at post-treatment study visits when compared with baseline pre-treatment satisfaction scores, as measured by the mean change from baseline on the Satisfaction with Lips FACE-Q questionnaire. For subjects who additionally receive treatment for oral commissures a significant proportion of subjects will achieve an improvement in Oral Commissures Severity Scale (OCSS) score(s) at post- treatment study visits when compared with baseline pre-treatment scores. Investigators’ and subjects’ global satisfaction with the aesthetic outcome will also be assessed.
Clinical Hypothesis. The combination of OPT-302 with aflibercept administered by repeat IVT injections will achieve acceptable safety / tolerability with clinical activity in participants with persistent center-involving DME. • Cohort 3: 2 mg aflibercept and 2 mg OPT-302 Following the third IVT injection participants will have a 4 week treatment free follow-up through week 12 and an additional longer-term follow-up through week 24 when standard of care IVT aflibercept retreatment will be based on protocol-specified retreatment criteria for persistent DME if visual acuity (VA) or central subfield thickness (CST) on SD-OCT worsens (defined as a ≥ 10% decrease increase in CST or a ≥ 5 letter decline in VA from the last study treatment phase visit [Day 57]). Dose escalation cohorts in the Phase 1b will enroll sequentially, starting with cohort 1. At least 3 patients must complete the 14 day DLT period at each dose level before the data review team can consider dose escalation.
Clinical Hypothesis. The Healing Ointment, consisting of skin protectant petrolatum and other beneficial ingredients, will be able to protect and promote healing of the wound site post-surgery.
Clinical Hypothesis. When each HA filler is injected and integrated into the tissue, it will add volume to the skin to achieve different lifting and contouring effect.
