Eyeworld

90 | EYEWORLD | MARCH 2021 C ORNEA Contact de Luise: vdeluisemd@gmail.com Perry: hankcornea@gmail.com Tseng: stseng@ocularsurface.com Yeu: eyeulin@gmail.com Relevant disclosures de Luise: None Perry: Alcon, BlephEx Tseng: TissueTech Yeu: Tarsus Pharmaceuticals, TissueTech toxic, as noted by the other physicians. He has thus identified the active ingredient of tea tree oil as terpinen-4-ol. Dr. Tseng co-authored a paper discussing Cliradex (Bio-Tissue), 3 eyelid cleansing products that contain terpinen-4-ol. He found it to be an effective way to treat Demodex infestations in patients. Dr. de Luise said direct removal of the mites at the slit lamp can be performed but is time-consuming, and many mites will be bur- rowed in the glandular tissue and not able to be seen. He also mentioned the use of Cliradex for these patients. According to Dr. Yeu, recent literature demonstrated that terpinen-4-ol was harmful to human meibomian gland epithelial cells in vitro. 4 Dr. Yeu said that more research is needed here to assess the potential damage of meibo- mian glands. Another option currently in trials is from Tarsus Pharmaceuticals, a late-stage biopharma company that has developed a topical lotilaner 0.25% ophthalmic solution, TP-03. According to Dr. Yeu, it is designed to paralyze and eradi- cate the mites and other parasites through the inhibition of the parasite-specific GABA chloride channels. So far, the company has completed four Phase 2 clinical trials, and Dr. Yeu noted that the product was well tolerated ("neither comfortable nor uncomfortable," "comfortable," or "very comfortable" 87% of the time) and met both primary endpoints (which included collarette cure and mite eradication) in all four Phase 2 studies. In the single-arm open-label trial Io, TP-03 was effective at achieving the primary endpoints of collarette cure in 72% of participants and Demodex mite eradication in 78% of patients at day 42. The randomized, vehicle-controlled Europa study achieved a collarette cure in 80% of participants on TP-03 compared to 16% on vehicle (P<.001) at day 42, and mite eradication was achieved in 73% of participants on TP-03 compared to 21% on vehicle (P=.003) at day 42, Dr. Yeu said. TP-03 specifically targets the mite nervous system to kill the mites on the GABA chloride channels, treating the underlying cause of dis- ease, Dr. de Luise said. The company presented that TP-03 has rap- id, complete, and durable efficacy with no seri- ous adverse events, Dr. de Luise said. Patients reported that the drop is comfortable with zero study discontinuations due to tolerability. In September 2020, Tarsus commenced its FDA Phase 2B/3 pivotal registration study, known as Saturn-1, and planned to enroll more than 400 participants in 14 locations, Dr. Yeu said. The primary objective of the Saturn-1 trial is to assess the safety and efficacy of TP-03 compared to its vehicle from day 1 to day 43 in adult participants with mild to severe Demodex blepharitis, Dr. Yeu said. The primary efficacy endpoints mimic the latter Phase 2 studies and are the collarette cure, defined as the presence of no more than two collarettes on the upper eyelid, and mite eradication rate of zero on the lash of the upper eyelid. The secondary end- point is a composite score of the collarette cure plus erythema score. Safety will be determined by assessing adverse effects related to the treat- ment as well as evaluating any changes in visual acuity, intraocular pressure, slit lamp biomicros- copy, and dilated ophthalmoscopy findings. Cylindrical dandruff on left and after microblepharoexfoliation (BlephEx) on right Source: Henry Perry, MD continued from page 89

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