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Ocular tolerance and safety assessment

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 02 October 2012. 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

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(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).

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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

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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

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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

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