The Gordon Schanzlin New Vision Institute, Inc.

Localized heat therapy with manual expression has been effective for meibomian gland dysfunction-associated dry eye disease in clinical studies including two randomized controlled trials, and in the present report, provides long-lasting relief from signs and symptoms for moderate-to-severe dry eye disease associated with meibomian gland dysfunction.

Meibomian gland dysfunction is a disease with high prevalence and accounts for most dry eye disease. Localized heat therapy with manual expression, an office-based intervention, has demonstrated effectiveness in improving the signs and symptoms of dry eye disease. The aim of this third phase of the Sahara randomized controlled trial was to study the durability of the treatment benefits.

Subjects randomized to localized heat therapy in Sahara and receiving second treatment at month 5 continued follow-up for an additional 19 months. Ocular signs including tear break-up time and meibomian gland secretion score, and symptoms including ocular surface disease index were assessed at months 6, 9, 12, 15, 18, and 24. Subjects could be retreated when tear break-up time was within 2 seconds of study baseline and ocular surface disease index increased by 15 points from the previous visit.

One hundred sixty-six subjects entered this phase of the study. All measures of signs and symptoms (for the overall group of subjects) remained statistically significantly better than study baseline at all time points. Thirty-two subjects required additional treatment. Median time for retreatment was 8 months. Six-month retreatment-free survival probability was 92%. There were a few adverse events and none related to the localized heat therapy procedure.

Localized heat therapy with manual expression has been shown to be an effective treatment for meibomian gland dysfunction, providing durable relief from dry eye disease signs and symptoms. Treatment twice per year can provide meaningful improvement and symptomatic relief for patients with moderate-to-severe dry eye disease.

Purpose: To evaluate the durability of thermomechanical device treatment effect in patients with meibomian gland dysfunction (MGD) at 6 months post-treatment. Methods: This was an extension of an initial 3-month, prospective, controlled, randomized, masked, multicenter pivotal study, in which subjects with MGD were randomized to thermomechanical device treatment (3 sessions, 2 weeks apart) or a single control treatment. The extension study was a single-arm, observational study in the same 5 sites of the pivotal study. A subset of subjects from the thermomechanical device group with an increase in tear break-up time (TBUT) of 2.5 s or greater in at least 1 eye at 1- or 3-month follow-up and able to attend the 6-month follow-up were included. Effectiveness endpoints included changes in TBUT, Meibomian gland score (MGS), and Ocular Surface Disease Index (OSDI) from baseline to 6 months. Device-related adverse events (AEs) were also assessed. Results: At 6 months post-treatment, 21 subjects (42 eyes) demonstrated significant improvements from baseline in mean TBUT (5.2 ± 3.8 s; P < 0.001), mean MGS (18.2 ± 10.9; P < 0.0001), and mean OSDI (-24.3 ± 26.5; P = 0.0004). Improvements in corneal staining scores were also observed. No ocular AEs were reported. Conclusions: The findings of the extension study demonstrate that the clinical benefit of the thermomechanical device, evaluated by TBUT, MGS, and OSDI, can be maintained out to 6 months and that the device is safe and effective in improving the signs and symptoms of evaporative dry eye disease in MGD.

Cenegermin is approved for treatment of neurotrophic keratopathy (NK) and has been studied in patients with stage 2 or 3 NK. This study evaluated the efficacy and safety of cenegermin in adults with stage 1 NK.

This was a phase IV, multicenter, prospective, open-label, uncontrolled trial. Adults with stage 1 NK (Mackie criteria) and decreased corneal sensitivity (≤ 4 cm) received 1 drop of cenegermin 20 mcg/ml in the affected eye(s) 6 times/day for 8 weeks with a 24-week follow-up.

Of 37 patients, corneal epithelial healing was observed in 84.8% (95% confidence interval [CI] 68.1-94.9%; P < 0.001) at week 8; 95.2% (95% CI 76.2-99.9%; P < 0.001) of those patients remained healed at the end of the 24-week follow-up (week 32). At week 8, 91.2% (95% CI 76.3-98.1%; P < 0.001) of patients experienced improved corneal sensitivity; this improvement was observed in 82.1% (95% CI 63.1-93.9%; P < 0.001) of patients at week 32. Mean best-corrected distance visual acuity change from baseline at week 8 was - 0.10 logMAR (standard deviation [SD], 0.15; 95% CI - 0.16 to - 0.05; P < 0.001) and at week 32 was - 0.05 logMAR (SD, 0.16; 95% CI - 0.11 to 0.01; P = 0.122). At weeks 8 and 32, 15.2% (95% CI 5.1-31.9%; P < 0.001) and 10.7% (95% CI 2.3-28.2%; P < 0.001) of patients, respectively, had a 15-letter gain from baseline. At least one adverse event (AE) was reported by 73.0% and 45.7% of patients during the treatment and follow-up periods, respectively. The most common treatment-related, treatment-emergent AEs were eye pain (37.8%), blurred vision (10.8%), and eyelid pain (8.1%); these were mostly mild or moderate and were only reported during the treatment period.

These results support the potential use of cenegermin for treating patients with stage 1 NK, and future confirmatory studies would be beneficial to elaborate on these findings.

DEFENDO; NCT04485546.