The OC-02 RANIER and PEARL studies are complete, but data have not been released. The OC-01 MYSTIC (ClinicalTrials.gov Identifier: NCT03873246) and IMPERIAL (ClinicalTrials.gov Identifier: NCT03688802) studies are recruiting with an expected study completion date in August; the ONSET-1 study is complete, but data have not been released. According to the company, in Phase 2b clinical studies patients administered either OC-01 or OC-02 experienced rapid and significant improvements in both the signs and symptoms of DED.
Both were well-tolerated with no significant ocular adverse events or drug-related serious adverse events.
ReGenTree will begin enrolling patients into ARISE-3, a phase 3 trial designed to evaluate RGN-259 for the treatment of DED (ClinicalTrials.gov Identifier: NCT03937882).
RGN-256 is a preservative-free sterile eye drop solution containing Thymosin beta 4 designed for direct instillation into each eye.
ARISE-3 is designed to compared RGN-259, dosed QID for 14 days, against placebo. The trial is expected to enroll 700 patients in 15 sites across the United States.
The primary completion date is expected to be April 2020, with final completion in July 2020.
TearCare, from Sight Sciences, is a wearable, open-eye technology that delivers regulated, localized heat to the eyelids to clear the meibomian glands of obstructions and restore the production of healthy meibum.
Sight Sciences is now enrolling patients into OLYMPIA, a prospective, multicenter, randomized, controlled study designed to compare the safety and efficacy of TearCare to the LipiFlow Thermal Pulsation System (Johnson & Johnson Vision) in patients with dry eye disease. The TearCare SmartLids will be applied to the external surface of each eyelid.
The TearCare System will be turned on and heat will be delivered to the eyelids for 15 minutes. Immediately following the thermal portion of the procedure, the SmartLids will be removed and the doctor will manually express the meibomian glands.
The LipiFlow activators will be placed between the inner eyelid and the corneal surface of each eye. The LipiFlow System will be turned on and heat and pressure will be delivered to each eyelid for 12 minutes. OLYMPIA will enroll 138 patients across 10 centers in the United States and has a target completion date of October 2019. (ClinicalTrials.gov Identifier: NCT03857919)
Topivert Pharma’s TOP1630, a novel anti-inflammatory kinase inhibitor, is in a multicenter, randomized, placebo-controlled phase 2b/3 trial that will enroll 200 patients with moderate and severe DED compared to placebo (ClinicalTrials.gov Identifier: NCT03833388). Primary endpoints include ocular grittiness and ocular surface lissamine green staining at day 29. Top line data are expected later this year.
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