Enhancing Ocular Surface in Dry Eye Disease Patients: A Clinical Evaluation of a Topical Formulation Containing Sesquiterpene Lactone Helenalin.

The aim of this work was to assess the tolerability, safety, and efficacy of an ophthalmic topical formulation containing helenalin from Arnica montana and hyaluronic acid 0.4% (HA) in patients with mild-to-moderate Dry Eye Disease (DED) exhibiting positive Matrix Metalloproteinase 9 (MMP-9) test results. Tolerability and safety were evaluated in 24 healthy subjects. Participants were instructed to apply one drop of the formulation three times a day in the study eye, for 2 weeks, followed by a clinical follow-up of 21 days. Efficacy was studied in 48 DED patients randomized into Study (Group 1/receiving the studied formulation) or Control (Group 2/Receiving HA 0.4% eye lubricant) groups for 1 month. Assessments included an MMP-9 positivity test, conjunctival impression cytology (CIC), Ocular Surface Disease Index (OSDI), non-invasive film tear breakup time (NIBUT), non-invasive average breakup time (NIAvg-BUT), ocular surface staining, Schirmer's test, and meibomiography. A crossover design with an additional 1-month follow-up was applied to both groups. Healthy subjects receiving the studied formulation exhibited good tolerability and no adverse events. Regarding the efficacy study, Group 1 exhibited a statistically significant reduction in the MMP-9 positivity rate compared to Group 2 (p < 0.001). Both Group 1 and Group 2 exhibited substantial improvements in OSDI and NIBUT scores (p < 0.001). However, Group 1 demonstrated a significant improvement in NI-Avg-BUT and Schirmer's test scores (p < 0.001), whereas Group 2 did not (p > 0.05). Finally, after the crossover, the proportion of MMP-9-positive subjects in Group 1 increased from 25% to 91.6%, while Group 2 showed a significant decrease from 87.5% to 20.8%. Overall, the topical formulation containing sesquiterpene helenalin from Arnica montana and hyaluronic acid was well tolerated and exhibited a favorable safety profile. Our formulation reduces DED symptomatology and modulates the ocular surface inflammatory process; this is evidenced by the enhancement of CIC, the improvement of DED-related tear film status, and the reduction of the MMP-9 positivity rate.

The Evolution of Triamcinolone Acetonide Therapeutic Use in Retinal Diseases: From Off-Label Intravitreal Injection to Advanced Nano-Drug Delivery Systems.

Ophthalmic drug delivery to the posterior segment of the eye has been challenging due to the complex ocular anatomy. Intravitreal injection of drugs was introduced to deliver therapeutic doses in the posterior segment. Different posterior segment diseases including age-related macular degeneration, diabetic macular edema, retinal vein occlusions, uveitis, and cystoid macular edema, among others, have been historically treated with intravitreal corticosteroids injections, and more recently with intravitreal corticosteroids drug implants. Triamcinolone acetonide (TA) is the most frequently used intraocular synthetic corticosteroid. Using nanoparticle-based TA delivery systems has been proposed as an alternative to intravitreal injections in the treatment of posterior segment diseases. From these novel delivery systems, topical liposomes have been the most promising strategy. This review is oriented to exhibit triamcinolone acetonide drug evolution and its results in treating posterior segment diseases using diverse delivery platforms.

An insight on the eye bacterial microbiota and its role on dry eye disease.

The human ocular surface hosts a bacterial assemblage that integrates a diverse and complex microbiome. This bacterial microbiota is part of a healthy eye and plays a protective role in it. However, this ocular bacterial assemblage may alter the ocular surface inflammation response and can influence the development and progression of dry eye disease. For this reason, the present review describes the changes generated on the ocular surface by bacterial assemblages during the development of dry eye disease. Likewise, the interaction of this microbiota with the other inflammatory factors that influence the development of this disease is analyzed, as well as the use of treatments focused on modifying the bacteria on the ocular surface.

Tratamiento a largo plazo del dolor pélvico con levonorgestrel en mujeres con endometriosis que desean posponer el embarazo y preservar su fertilidad. Serie de casos / Long-term management of pelvic pain with levonorgestrel in women with endometriosis who desire to postpone a future pregnancy and preserve their fertility. Case Series

Resumen OBJETIVO: Valorar el tratamiento a largo plazo del dolor pélvico con levonorgestrel en mujeres con endometriosis que desean posponer el embarazo y preservar su fertilidad. MATERIALES Y MÉTODOS: Estudio ambispectivo, con intervención medicamentosa, longitudinal y descriptivo de serie de casos. Parámetros de estudio: medición de la intensidad del dolor a los 12, 24 y 36 meses posteriores a la colocación de un implante único de goserelina (Zoladex de 10,6 mg, AstraZeneca AB, Gärtunavägen). Al retorno de la menstruación se colocó un dispositivo intrauterino con levonorgestrel (Mirena Bayer AG, Leverkusen). La intensidad del dolor pélvico se midió con la Escala Numérica del Dolor (Escala ENA). RESULTADOS: Se estudiaron 14 pacientes de las que 5 refirieron dolor: 4 con intensidad 1 y una con intensidad 3. El resto de las pacientes no refirió dolor. Todas las pacientes refirieron alivio general subjetivo a los 12 meses de seguimiento. CONCLUSIONES: El levonorgestrel administrado por vía intrauterina puede ser una alternativa para mantener, a largo plazo, sin dolor a pacientes con endometriosis que desean posponer el embarazo. Para confirmar lo aquí encontrado hacen falta estudios controlados, con asignación al azar y con un tamaño de muestra realmente representativo.

Abstract OBJECTIVE: To assess the long-term treatment of pelvic pain with levonorgestrel in women with endometriosis who wish to postpone pregnancy and preserve their fertility. MATERIALS AND METHODS: Ambispective study, with drug intervention, longitudinal and descriptive case series. Study parameters: measurement of pain intensity at 12, 24 and 36 months after placement of a single goserelin implant (Zoladex 10.6 mg, AstraZeneca AB, Gärtunavägen). At the return of menstruation, an intrauterine device containing levonorgestrel (Mirena Bayer AG, Leverkusen) was inserted. The intensity of pelvic pain was measured with the Numerical Pain Scale (NPS). RESULTS: Fourteen patients were studied of whom five reported pain: four with intensity 1 and one with intensity 3. The rest of the patients reported no pain. All patients reported subjective general relief at 12 months follow-up. CONCLUSIONS: Levonorgestrel administered intrauterine may be an alternative for the long-term pain-free treatment of patients with endometriosis who wish to postpone pregnancy. Controlled, randomized studies with a truly representative sample size are needed to confirm the findings.