Cyclosporin-a based eye drops for dry eye and ocular inflammatory diseases

MICELLAR CYCLOSPORIN A-BASED EYE DROPS.

CyclosporinA (CsA) is an immunosuppressorused in eye drops to increase tear production in people with dry eye disease. Insolubility of CsAin aqueous solutions requires specific production techniques for efficient drug delivery to the eye. However, CsAemulsions are associated with discomfort and pain in patients

We have developed a strategy to deliver a solubilized state of CsAto the eye by encapsulating CsAinto a micellar hydrophobic fraction that represents only 20% of the final eye drop volume with contains residual amounts of ethanol. Our eye drops are preservative-free and felt by patients as an aqueous solution with no associated discomfort and pain.

The manufacturing process allows the addition of lubricants such as hyaluronic acid or povidone and concentrations of CsAup to 20 mg / ml, allowing to address dry eye and inflammatory ocular diseases markets.

 Competitive Advantages

● Unique micellarcyclosporinA (CsA) basedeyedrop formulations

● Formulations availablefor a large range of CsA(1 to 20 mg/ml)

● Provenefficacyof CsAin inflammatoryeyediseases

● Compositions treatcauses and symptomsof dry eyeand inflammation

● CsAeyedrops avoidor substitute to toxiccorticoid-basedtreatments

● Topicaladministration withno sideeffects

● Povidone or Hyaluronicacidas lubricantswithprovenefficacy

● Preservative-free products

● Micellarcomposition avoidsdiscomfortof emulsion-basedeyedrops

● Single-dose or 1-month format packages possible

Development Status

● Original formulation alreadyusedby hundredsof patients

● Production process of the new formula has been optimized

● Stabilitystudiesongoing

● Extractibles / leacheablesstudyongoing

● Preclinicalefficacyand toxicitystudiesongoing

Business Opportunities

● Opportunity to addressmultiple marketsof eyediseases

● Large, underservedglobal dry eyemarket(> 300 million people)

● Human and veterinarymarkets

● Possibilityof OrphanDrug Designationon specificindications

● Facilitatedregulatoryapprovalprocess

● Short time-to-marketanticipated

● High grossmarginon premium severeeyediseasesmarketsegment