Iris Pharma offers the regulatory safety GLP program:
Prior to proof of concept or efficacy studies, Iris Pharma suggests a quick evaluation (non-GLP) of the ocular tolerance of your compound or formulation.
ACUTE TOLERANCE
Guidelines: OECD Guideline for testing of chemicals - Guideline 405 : Acute Eye Irritation/Corrosion - adopted 12 May 1981, last updated 24 April 2002. European Commission Directive # 92/69/EC (July 31, 1992) - Offic. J. Eur. Commun. 1992; 35, L383: B5
Administration: topical ocular administration: 1 x 100 µl
Animals: albino rabbits: 3 per group
Evaluation: Draize test at 5 min, 60 min, 1, 2 and 3 days (4 and 7 days if necessary)
Groups: test article, vehicle (when applicable), control substance
(SUB-)CHRONIC TOLERANCE
Guidelines: OECD Guideline for testing of chemicals - Guideline 410 : Repeated Dose Dermal Toxicity: 21/28-Day study, adopted 12 May 1981. European Commission Directive # 92/69/EC (July 31, 1992) - Offic. J. Eur. Commun. 1992; 35 L383: B9
Formulation (GMP): Eyedrop, gel, ointment, devices (insert, implant…), particles, patch, cream...
Administration: topical ocular application, intravitreal injection (IVT), subconjunctival injection, subTenon injection (SBT), retrobulbar injection, periocular injection, intracameral injection, subretinal, intrascleral, transscleral, intrastromal, iontophoresis…
Animals: albino rabbits: at least 5 males and 5 females per group
Dosage: multiple daily administration for 28 days or more
Evaluation:
- Daily: Draize scale, food and water consumptions
- Weekly: McDonald-Shadduck scale and body weight, food and water consumptions
- Autopsy, main organ weight and ocular histology
- ERG, IOP, HRT, hematology, blood biochemistry, organ histology : customization according to the test substance
Groups: test article, vehicle (when applicable), control substance, reference substance (when applicable).
CORNEAL ANESTHESIA
Guidelines: EMEA (CPMP) note for guidance on non-clinical local tolerance testing of medicinal products (adopted February 2001) CPMP/SWP/2145/00
Formulation: eyedrop, gel, ointment, cream, …
Administration: topical, iontophoresis…
Animals: albino rabbits
Evaluation: Cochet Bonnet esthesiometer
Parameters: number of mechanical stimuli necessary to induce a blinking reflex within 1 hour
Reference substances: oxybuprocaine / tetracaine
LACRIMINATION
Guidelines: EMEA (CPMP) note for guidance on non-clinical local tolerance testing of medicinal products (adopted February 2001) CPMP/SWP/2145/00
Administration: topical, iontophoresis...
Animals: albino rabbits
Evaluation: Schirmer strips, microcapillaries
Parameters: quantity of tears collected in 5 min
Reference substances: pilocarpine
PUPILLARY DIAMETER
Guidelines: EMEA (CPMP) note for guidance on non-clinical local tolerance testing of medicinal products (adopted February 2001) CPMP/SWP/2145/00
Administration: topical, iontophoresis…
Animals: albino rabbits
Evaluation: graduated rule
Parameters: measurement in mm versus time
Reference substances: pilocarpine or atropine
