Perfluorohexyloctane eye drops preservative free

Background: Dry eye disease (DED) associated with meibomian gland dysfunction lacks a conclusive treatment, placing existing solutions under the burden of side effects and limitations. This study seeks to assess the efficacy and safety of perfluorohexyloctane (PFHO) in treating DED associated with meibomian gland dysfunction. Methods: A thorough search encompassing Medline, Cochrane Central Register, and Google Scholar was conducted until September 15, 2023. Four randomized controlled trials were assessed for PFHO’s safety and efficacy. Studies were managed with EndNote and Excel for dual-phase screening by reviewers. Bias risk was evaluated with the risk of bias 2.0 Cochrane tool, and comparative outcomes were synthesized using RevMan software. Results: In this meta-analysis, we pooled data from 4 randomized controlled trials involving 1754 patients. Significant reductions were observed in total corneal fluorescein staining score mean difference = −0.87 (95% CI −1.06, −0.68, P < .00001), eye dryness score mean difference = −7.73 (95% CI −9.17, −6.29, P < .00001), and central Corneal Fluorescein Staining score risk ratios (RR) = 5.11 (95% CI: 1.75–14.93, P = .003). Subgroup analysis highlighted increasing differences over time, notably at week 8. Safety analysis showed decreased risk of eye pain RR = 0.70 (95% CI: 0.27, 1.80, P = .46) and blurred vision RR = 5.11 (95% CI: 1.75, 14.93, P = .003) with PFHO. There was no significant difference noted in serious adverse events RR = 1.38 (95% CI: 0.25, 7.60, P = .71), ocular TEAS RR = 1.05 (95% CI: 0.81, 1.37, P = .69) and non-ocular TEAS RR = 1.02 (95% CI: 0.75, 1.40, P = .89). Conclusion: PFHO marks a novel treatment for DED, targeting tear evaporation with its unique water-free, preservative-free preparation. It has proved to be highly effective in alleviating eye dryness and associated symptoms. While minor side effects are seen in a small subset of patients, the overall safety is promising. Further long-term and larger sample size studies will offer a more thorough understanding of this new drug.

Abstract licence: CC BY 4.0

INTRODUCTION: The new preservative-free treatment for dry eye patients, perfluorohexyloctane, has been considered in recent studies. This study aimed to assess the feasibility of perfluorohexyloctane for dry eye treatment.  METHODS: This review was conducted following the PRISMA guidelines. We performed a comprehensive literature search across five online databases: PubMed, Cochrane, ProQuest, ScienceDirect, and Google Scholar. Human studies using perfluorohexyloctane as dry eye or dry eye disease (DED) therapy published in English, and full-text journals available were inclusion criteria in this review. We identified corneal fluorescein staining (CFS) as the main outcome measurement.  RESULTS: Five RCTs and two cohort studies were analyzed. Most studies were conducted in Western countries, except one RCT in China. One hundred percent perfluorohexyloctane was used in all studies. All studies showed improvement in CFS to the control group, with a significance level of p ≤ 0.001, except for one study where p = 0.2786.  CONCLUSION: Perfluorohexyloctane shows promising potential as a new therapeutic approach for patients with dry eye disease, but additional research is needed, especially in Eastern countries.  Keywords: Dry eye disease, meibomian gland dysfunction, dry eye treatment, perfluorohexyloctane, eye drops, systematic review. 

Abstract licence: CC BY-NC-ND 4.0

Introduction: Dry eye disease (DED) is a prevalent and debilitating ocular condition characterized by discomfort, visual disturbances, and tear film instability. Recent therapeutic developments have introduced perfluorohexyloctane ophthalmic solution (Miebo®) as a potential treatment for DED, particularly in patients with meibomian gland dysfunction (MGD). Aim of the Study: This narrative review aims to evaluate the efficacy and safety of Miebo® in treating DED based on current clinical evidence. Materials and Methods: A comprehensive literature search was conducted in PubMed, Embase, and Cochrane Library databases up to May 2024 resulting in the identification of 9 studies. The review included randomized controlled trials, prospective cohort studies, and systematic reviews that focused on the use of Miebo® for DED. Data on efficacy in improving tear film stability and symptom relief, as well as safety profiles, were extracted and analyzed. Results: The evidence indicates that Miebo® significantly enhances tear film stability and alleviates symptoms of DED, with pronounced benefits observed in patients with MGD. Comparative studies demonstrate that Miebo® is more effective than conventional treatments, such as artificial tears and lipid-based formulations. Safety assessments reveal minimal ocular surface discomfort and no significant systemic adverse events associated with Miebo® use. Conclusion: Miebo® shows substantial efficacy and a favorable safety profile in managing DED, making it a valuable therapeutic option, particularly for patients who do not respond to traditional therapies. However, further research is needed to confirm its long-term effectiveness and safety.

Abstract licence: CC BY-NC-SA 4.0

Abstract Introduction: The aim of the study was to systematically review the evidence from randomized controlled trials that evaluate the efficacy and safety of perfluorohexyloctane in the treatment of dry eye disease. Methods: Literature search was conducted on PubMed and Scopus in April 2024 with the search strategy (“perfluorohexyloctane” or “NOV03” or “semifluorinated alkane”) and “dry eye.” Extension and paired-eyes study were excluded. The risk of bias was assessed using the Cochrane risk-of-bias tool. Forest plots and a summary of findings were prepared for total corneal fluorescein staining (tCFS), tear film break-up time (TFBUT), eye dryness score (EDS), and Ocular Surface Disease Index (OSDI). Results: The pooled standardized mean difference (SMD) for tCFS after 8 weeks of treatment was −0.53 (95% CI: −0.68 to −0.38; p < 0.001), indicating a significant improvement in patients treated with perfluorohexyloctane. The between-study heterogeneity was moderately high (I2 = 52.0%). No significant differences in TFBUT were observed (SMD = 0.05; 95% CI: −0.16 to 0.25; p = 0.654). Regarding symptoms, patients treated with NOV03 had significantly lower EDS compared to controls (SMD = −0.49; 95% CI: −0.66 to −0.32; p < 0.001), with moderately high heterogeneity (I2 = 71.1%). Conversely, the pooled SMD of OSDI was −0.13 (95% CI: −0.43 to 0.17; p = 0.412), indicating no significant difference. Conclusion: Perfluorohexyloctane is an effective and safe alternative for the treatment of evaporative dry eye disease due to MGD that can significantly reduce tCFS and eye dryness symptoms. More well-designed non-sponsored randomized clinical trials are required to investigate the impact on other ocular surface parameters.

Abstract licence: CC BY-NC 4.0

Dry eye disease (DED) is a multifactorial disorder characterized by disruption of tear film homeostasis, resulting in ocular surface inflammation and damage. Although several Food and Drug Administration-approved topical treatments are available, direct comparisons of their efficacy and safety are complicated by variability in study designs and corneal staining grading scales. This review systematically evaluates and compares the efficacy and safety of topical therapies approved in the United States, focusing on anti-inflammatory and semi-fluorinated alkane (SFA)-based therapies. A systematic literature review identified 12 randomized controlled trials involving a total of 6,984 patients with varying severity of DED eligible for inclusion, with 8 providing data suitable for quantitative meta-analysis and 5 for exploratory regression analysis. Meta-analysis indicated that cyclosporine 0.1%/SFA showed the most significant early improvement (within ≤4 weeks) in total corneal fluorescein staining, outperforming other treatments. Exploratory regression analysis further supported these findings, demonstrating that cyclosporine 0.1%/SFA had the fastest and most consistent reduction in corneal staining, with the steepest improvement slope and strong predictability (R2 = 0.871). Safety analyses highlighted improved local tolerability for SFA-based therapies compared with traditional anti-inflammatory treatments, notably lower instillation site discomfort for both cyclosporine 0.1%/SFA (2.5%-9.9%) and perfluorohexyloctane (≤1%) vs. other cyclosporine formulations. SFA-based therapies, especially cyclosporine 0.1%/SFA, demostrated robust efficacy in improving signs of DED with superior tolerability profiles compared to traditional anti-inflammatory treatments. These findings support the role in effectively managing ocular surface inflammation and optimizing treatment strategies in DED.

Abstract licence: CC BY

Background Dry eye disease (DED) is commonly caused by excessive tear film evaporation due to Meibomian gland dysfunction (MGD). There is a need for DED treatment options that address tear evaporation and benefit patients across a broad range of demographic and disease characteristics. This study evaluated treatment effects of perfluorohexyloctane ophthalmic drop (formerly NOV03) in the pooled dataset from 2 pivotal clinical trials in patients with DED associated with MGD, both in the overall population and in patient subgroups based on sex, age, and baseline severity of eye dryness. Methods Pooled data from 2 similarly designed, phase 3, randomized controlled trials (GOBI, MOJAVE) were analyzed. Patients aged ≥18 years with DED administered perfluorohexyloctane (n=614) or hypotonic (0.6% solution) saline control (n=603) four times daily for 8 weeks. Primary endpoints were total corneal fluorescein staining (tCFS) score (National Eye Institute scale, 0-15) and eye dryness visual analog scale (VAS) score (0-100). Efficacy was evaluated using analysis of covariance among patient subgroups (male and female, older [≥65 years] and younger [18 to <65 years], tCFS score <7 and ≥7, VAS eye dryness score <70 and ≥70, MGD score <7 and ≥7, Schirmer I test <10 mm and ≥10 mm). Results Reductions in tCFS and VAS eye dryness scores were greater for perfluorohexyloctane versus control. In the overall patient population, least-squares mean treatment difference was −1.1 (95% CI: −1.41 to −0.79; p<0.0001) for tCFS and −9.0 (95% CI: −11.90 to −6.00; p<0.0001) for VAS eye dryness. Treatment favored perfluorohexyloctane over control in all patient subgroup analyses of tCFS and VAS eye dryness. Overall, the most common adverse event with perfluorohexyloctane was blurred vision (2.1% of patients), which was mild and transient. Conclusions Compared with a hypotonic saline control, perfluorohexyloctane improved both the signs and symptoms of DED, including in patients with greater self-reported severity of eye dryness. Clinical trial registration This study represents an integrated analysis of 2 previous clinical trials: GOBI (ClinicalTrials.gov, NCT04139798) and MOJAVE (ClinicalTrials.gov, NCT04567329).

Abstract licence: CC BY 4.0