Perfluorohexyloctane eye drops preservative free

Perfluorohexyloctane (F6H8), a physically and chemically inert synthetic compound, has recently emerged as a promising candidate for the treatment of DED due to its unique properties. A systematic review that only include full-length randomized controlled studies (RCTs), reporting the effects of F6H8 in three databases, PubMed, Scopus and Web of Science, was performed according to the PRISMA statement. The search period was performed between June 1, 2023, and June 21, 2023. The Cochrane risk of bias tool was used to analyze the quality of the studies selected. A total of six RCTs were included in this systematic review. F6H8 tear substitutes treatment achieved a higher improvement than control group interventions in most of the reported variables. The mean differences between both groups were in favor of F6H8 and were as follow: eye dryness score (EDS) base on a visual analogue scale (VAS) of -6.12 ± 4.3 points, ocular surface disease index (OSDI) questionnaire score of -2.8 ± 2.3 points, lipid layer thickness (LLT) of 11.4 ± 10.4 μm, total corneal fluorescein staining (tCFS) of -0.8 ± 0.3 points and ocular treatment-emergent adverse events (TEAEs) of -0.66 ± 1.7. Tear film break-up time (TBUT) was the only variable in favor of control group with a mean of -0.5 ± 0.4 s. Patient satisfaction after F6H8 tear substitutes treatment was high. Therefore, F6H8 tear substitutes improve dry eye symptoms and signs with a satisfactory tolerability and could be recommended in patients with DED.

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Meibomian gland dysfunction (MGD) is the primary cause of evaporative dry eye disease (DED), which negatively affects the physical and mental quality of life of patients. We performed a meta-analysis of randomized controlled trials (RCTs) comparing perfluorohexyloctane to placebo for MGD in order to identify the best course of treatment for DED in these patients. We followed the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) guideline recommendations and prospectively registered the study in PROSPERO (CRD42023442172). The PubMed, Cochrane, and Embase databases were searched for RCTs comparing perfluorohexyloctane to placebo on patients with DED associated with MGD. The statistical analysis was carried out using the “R” software. The mean difference (MD) with 95% CIs was computed using a random-effects model, and p < 0.05 was regarded as statistically significant. The study included 1,814 patients from four RCTs, of whom 972 (53.5%) received perfluorohexyloctane. Patients treated with perfluorohexyloctane had significantly lower total corneal fluorescein staining (tCFS) score (MD -1.09; 95% CI -1.37 to -0.82; p < 0.001; I2 = 0%), eye distress Visual Analogue Scale (VAS) (MD -9.69; 95% CI -12.01 to -7.36; p < 0.01; I2 = 0%), Ocular Surface Disease Index (OSDI) (MD -5.79; 95% CI -8.22 to -3.36 p < 0.01; I2 = 0%), and Eye Burning/Stinging Score (VAS) (MD, -7.16; 95% CI -9.55 to -4.80 p < 0.01; I2 = 0%). The meta-analysis results indicate that perfluorohexyloctane was effective and safe in treating evaporative dry eye, reducing tCFS, eye discomfort, OSDI, and burning sensation, despite the included studies only assessing short-term effects and excluding certain patient groups.

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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.

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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 ( R 2 = 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.

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Dry eye disease (DED) is a common condition that affects mainly older individuals and women. It is characterized by reduced tear production and increased tear evaporation. Symptoms include burning, irritation, tearing, and blurry vision. This paper reviews key trials of various new DED treatments, including their mechanism of action, study outcomes, safety, and efficacy. The paper also includes a critical assessment of the trial's validity and potential pharmacy applications of these new treatments. The literature search was conducted through PubMed, the Cochrane Central Register of Controlled Trials, and Google Scholar. The keywords "Dry Eye Disease", "lifitegrast", "cyclosporine", "loteprednol etabonate", "varenicline nasal spray", and "perfluorohexyloctane" were used to identify these medications' landmark trials. The articles deemed these medications safe and efficacious, with minimal side effects. Our randomized controlled trial validity comparison found the trials robust with predominantly low bias. Cyclosporine and loteprednol are effective when artificial tears fail, while perfluorohexyloctane reduces tear film evaporation and is preservative-free. Varenicline offers drug delivery via the nasal route and is appropriate for contact lens users. In conclusion, these FDA-approved novel medications exhibit safety and efficacy in managing DED. Further research is needed on long-term outcomes, efficacy, and side-effect comparisons, and combination therapy benefits.

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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).

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Perfluorohexyloctane ophthalmic solution (Miebo) and water-free cyclosporine ophthalmic solution 0.1% (Vevye) are recently approved treatments for dry eye disease (DED). Perfluorohexyloctane (PFHO) uses a novel approach to treat evaporative DED, whereas water-free cyclosporine (CsA 0.1%) is formulated to increase ocular delivery of its active ingredient to improve tear production. The two medications utilize the distinctive properties of two different semifluorinated alkanes (SFAs) to elicit their therapeutic effects. PFHO consists of 100% active ingredient and forms a monolayer on the surface of the tear film to inhibit evaporation. CsA 0.1% utilizes a vehicle consisting of perfluorobutylpentane (PFBP) and ethanol to facilitate delivery of cyclosporine to ocular tissues. The structure of these SFAs determines their differing behaviors and functions. The longer chain length of PFHO results in a slower evaporation rate and facilitates formation of a stable monolayer on the ocular surface. In vitro, PFHO demonstrated a substantially lower evaporation rate versus PFBP or human meibum, as well as a significantly longer ocular surface residence time. Ex vivo, PFHO demonstrated a longer ocular surface residence time than PFBP. The shorter chain length of PFBP enables it to better solubilize cyclosporine and improve drug delivery to ocular tissues. Although both of these ophthalmic drops utilize SFAs, their differences-in physicochemical properties and the mechanisms by which they are understood to intervene in the DED cycle-are important considerations in treatment selection for patients with DED.

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