Successfully Improving Ocular Drug Delivery Using the Cationic Nanoemulsion, Novasorb

Table 7

Listing of safety screening and regulatory toxicity studies performed in order to test Novasorb technology in humans.

Nonclinical; studies type	Safety studies for Novasorb alone; and loaded Novasorb
Safety screening	(i) Draize test
	(ii) Demonstration in a repeated acute rabbit toxicity model that BAK and CKC containing emulsion are well tolerated
	(iii) Ocular safety evaluation of newly developed in vitro corneal wound healing model and in an acute in vivo rabbit model
	(iv) In vivo toxicity evaluation of latanoprost cationic emulsion in the rabbit
Regulatory toxicity studies	(i) In vitro evaluation of the cytotoxic potential by indirect contact
	(ii) Delayed-type hypersensitivity evaluation in the Guinea pig
	(iii) Ocular irritation test in the rabbit (short term: 72 h) following a single application
	(iv) Determination of the physical compatibility of Novasorb with contact lenses
	(v) 28-day ocular tolerance in the rabbit
	(vi) Evaluation of the potential to induce delayed contact hypersensitivity (local lymph node assay)
	(vii) Evaluation of the corneal sensitivity following repeated applications in albino rabbits
	(viii) Phototoxicity and photoallergic potential evaluation following topical applications in the Guinea pig
	(ix) 6-month ocular toxicity in the dog and rabbit