Patients with dry eye disease experienced significant symptom relief within minutes after using Miebo, according to newly published Phase 4 clinical data. The study, published in Ophthalmology and Therapy, demonstrates that Bausch + Lomb's perfluorohexyloctane ophthalmic solution provides rapid and sustained relief for dry eye symptoms, potentially addressing a critical need for timely symptom management.
Rapid Symptom Relief Demonstrated
The prospective, multicenter, open-label Phase 4 study included 99 patients with a history of dry eye disease (DED) for six months or longer. Participants, predominantly women (85.9%), administered Miebo in both eyes four times daily for 14 days.
Results showed substantial symptom relief within the first hour of treatment. The mean visual analog scale (VAS) score for overall dry eye symptoms decreased from 72.1 at baseline to 38.5 just 5 minutes after administration, further improving to 31.7 at 60 minutes post-administration.
"In this study, we looked at how quickly patients got relief and whether that relief seemed to stay consistent in those first few weeks," said Shane R. Kannarr, OD, who practices at Kannarr Eye Care in Pittsburg, Kansas. "We were surprised at exactly how quick Miebo worked."
By day 7, the primary endpoint showed mean overall symptom severity had decreased to 27.8, representing a mean change of -44.5 points from baseline (P < .0001).
Sustained Benefits Over Two Weeks
The study documented continued improvement throughout the 14-day treatment period. Key findings included:
- Mean percentage of time experiencing the most bothersome symptom dropped from 77.9% at baseline to 34.7% by day 14 (P < .0001)
- Mean frequency of awareness of dry eye symptoms decreased from 77.6% to 27.6%
- Fluctuations in vision quality reduced from 62.8% to 19.4%
Significant reductions occurred across specific symptoms, including eye irritation, blurred vision, eye itching, eye pain, eye tiredness, light sensitivity, eye dryness, and burning and stinging.
Patient Satisfaction and Compliance Implications
Patient satisfaction with Miebo increased throughout the study period, with median ratings of 83, 86, and 90 at days 3, 7, and 14, respectively. Participants described the treatment as "silky, smooth and soothing."
Dr. Kannarr emphasized the importance of these findings for treatment adherence: "One of the struggles we have in dry eye is making sure that patients adhere to the treatment protocol that we advise for them, because if you don't feel relief, you tend not to want to stay with it."
Andrew Stewart, president of Global Pharmaceuticals and International Consumer at Bausch + Lomb, noted, "These study results build on an impressive data set showing Miebo as a well-tolerated and effective treatment option for dry eye disease that also can deliver much-needed, fast-acting symptom relief."
Building on Previous Research
The new data builds upon results from the GOBI and MOJAVE pivotal studies, which had previously documented significant improvements in DED signs and symptoms as early as day 15, with continued improvement through day 57.
"When we combine it with the original data, we really think it projects out over the long term for our patients," Dr. Kannarr told Healio.
Safety Profile
Miebo was well-tolerated throughout the study, with no reports of treatment-related adverse events, reinforcing its favorable safety profile.
Future Research Directions
Dr. Kannarr highlighted areas for future investigation, including Miebo's potential benefits for contact lens wearers and its use in conjunction with other therapeutics, such as glaucoma medications.
"Rapid relief of dry eye symptoms is an important factor for adherence to treatment," Dr. Kannarr said. "These patient-reported results show that Miebo provided relief from dry eye symptoms quickly – in some cases in as little as 5 minutes after the patient's first use – and that relief was maintained and improved over the 2-week period."
