MiDROPS demonstrates safety, efficacy in phase 2 clinical trial
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EyeCRO announced that its Microemulsion Drug Ocular Penetration System, or MiDROPS, demonstrated safety and efficacy in its first clinical application as a topical eye drop vehicle for dry eye disease.
According to a company press release, the MiDROPS technology uses microemulsions to formulate and deliver lipophilic and insoluble drugs via topical eye drops, effectively treating disease by facilitating direct drug delivery into the tissues of the anterior and posterior segments of the eye.
At the recent Association for Research in Vision and Ophthalmology meeting in Seattle, Telios Pharma presented data from the proof-of-concept, phase 2 study, which evaluated twice-daily 0.1% TL-925 vs. vehicle over 28 days in 107 patients with moderate to severe dry eye disease. Both TL-925 and the MiDROPS vehicle were safe and well-tolerated, with a mean drop comfort score of 2.6 for both. It was the first clinical study to establish the role of Bruton’s tyrosine kinase (BTK) in the pathophysiology of dry eye disease, the release stated.
“This therapy could certainly be used in concert with other therapies and may even be superior to the existing first line of care for dry eye disease,” Rafal Farjo, PhD, EyeCRO CEO, told Healio.
“The inherent nature of MiDROPS allowed us to easily formulate TL-925 and accelerate advancement into clinical trials,” Jesse McGreivy, MD, Telios Pharma CEO, said in the release. “The clinical data presented [at ARVO] both establishes the safety of this novel vehicle platform and showcases the potentially paradigm-changing role of BTK inhibition to alleviate the signs and symptoms of patients with moderate to severe DED.”
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