Abstract
Purpose :
MC2 Therapeutics is developing PADciclo™, a new and optimized formulation of ciclosporin (CsA) based on PAD™ technology currently in clinical development for the treatment of moderate to severe dry eye. This new formulation contains less surfactants and is aimed to improve tolerability of CsA in dry eye. In these studies, ocular tolerance of PADciclo™ was determined up to 6 months in New Zealand White albinos rabbits.
Methods :
The PADciclo™ eye drop targets ocular inflammation which is well-known as one of the underlying causes of dry eye. Two studies were conducted. In a 28-day ocular tolerance study, animals received four ocular administrations per day of PADciclo™ vehicle or PADciclo™ 0.1% CsA, separated by intervals of approximately three hours. In a 6-month ocular tolerance study, animals received two ocular administrations per day of PADciclo™ vehicle or PADciclo™ 0.1% CsA. For both studies, clinical signs, corneal sensitivity, body weights and food and water consumption were monitored.
Results :
This is the first time that PADciclo™ tolerance data in animals are reported. PADciclo™ 0.1% CsA and PADciclo™ vehicle administered 4 times daily for 28 days or 2 times daily for 26 weeks in albino rabbits were macroscopically and microscopically very well tolerated. There were no treatment- or administration-related effects on body weight, clinical observations, food consumption, ophthalmic examinations, macroscopic observations at necropsy, or histopathology.
Conclusions :
The presented studies confirm that the PADciclo™ vehicle and PADciclo™ 0.1% CsA administered 4 times daily for 28 days or 2 times daily for 26 weeks is safe and very well tolerated by the rabbit eye.
This is an abstract that was submitted for the 2017 ARVO Annual Meeting, held in Baltimore, MD, May 7-11, 2017.