ArteFill® Permanent Injectable for Soft Tissue Augmentation: II. Indications and Applications

Patients ask for procedures with long-lasting effects. ArteFill is the first permanent injectable approved in 2006 by the FDA for nasolabial folds. It consists of cleaned microspheres of polymethylmethacrylate (PMMA) suspended in bovine collagen. Over the development period of 20 years most of its side effects have been eliminated to achieve the same safety standard as today’s hyaluronic acid products. A 5-year follow-up study in U.S. clinical trial patients has shown the same wrinkle improvement as seen at 6 months. Long-term follow-up in European Artecoll patients has shown successful wrinkle correction lasting up to 15 years. A wide variety of off-label indications and applications have been developed that help the physician meet the individual needs of his/her patients. Serious complications after ArteFill injections, such as granuloma formation, have not been reported due to the reduction of PMMA microspheres smaller than 20 μm to less than 1% “by the number.” Minor technique-related side effects, however, may occur during the initial learning curve. Patient and physician satisfaction with ArteFill has been shown to be greater than 90%

Cross-linked hyaluronic acid gel occlusive device for the treatment of dry eye syndrome

John P Fezza Center for Sight, Sarasota, FL, USA Purpose: A new cross-linked hyaluronic acid (xlHA) gel occlusive device was assessed for safety and efficacy in the treatment of dry eyes.Methods: This was an institutional review board-approved, single-site, open-label, prospective study to assess the efficacy and safety of placing the xlHA gel in the lower canaliculus. Seventy-four participants aged 25–95 years with dry eyes, who failed treatment with artificial tears, were included. Patients were assessed with corneal slit lamp examination with fluorescein staining and with Schirmer’s test, breakup time (TBUT), and tear meniscus height (TMH) at baseline, 1 month, and 3 months. Patients were followed at 6 months with a telephone questionnaire. The procedure entailed inserting ~0.2 mL of xlHA gel into each lower lid canaliculus with a syringe and lacrimal irrigator. Patients were followed for adverse events.Results: Sixty-three patients completed the study (48 females, 15 males), with an average age of 67 years. Slit lamp demonstrated improved corneal fluorescein staining. Schirmer’s tests demonstrated an average increase over baseline of 3.67 mm after 3 months. TBUT improved 87% and TMH increased by 57% at 3 months over baseline. All objective measures were statically significant. There was one case of conjunctivitis that resolved and was felt to be an incidental viral infection. Conclusion: The xlHA Occlusive Device offers a new, safe, and effective method to treat dry eyes. It appears to have efficacy for at least 3 months on clinical examination. The xlHA gel demonstrated a good tolerance and safety profile. Keywords: dry eyes, punctal plugs, canalicular plugs, hyaluronic acid, gel occlusive device, cross-linked hyaluronic acid gel&nbsp