Table 8: Listing of proof-of-concept and regulatory pharmacokinetics studies performed in order to test Novasorb technology in humans.

Nonclinical
studies type
Studies for Novasorb alone
and Novasorb loaded

Proof-of-concept(i) Ex vivo measurement of contact angle and surface tension of cationic emulsions on rabbit eyes
(ii) Evaluation and comparison of the wound healing potential of the cationic emulsion versus artificial tears in a rabbit model of corneal abrasion
(iii) Evaluation of the efficacy of a 0.1% cyclosporine A cationic emulsion in the management of keratoconjunctivitis sicca in the dog
(iv) Evaluation of the efficacy of a cationic emulsion of 0.005% latanoprost at reducing elevated intraocular pressure in glaucomatous monkeys
(v) In vitro and in vivo evaluation of a preservative-free cationic emulsion of latanoprost in corneal wound healing models

Regulatory pharmacokinetics studies(i) Single and multiple doses pharmacokinetic
(ii) Systemic exposure determination and toxicokinetics following repeated instillations of BAK and CKC-containing cyclosporine A cationic emulsion