Tuesday, May 31, 2011

Dry eye drug clinical trials - updates

Please check out the newly updated dry eye drug clinical trial roster.

Items that have been updated recently -

Novagali's Cyclokat, which completed a phase III last year and mentioned positive results in a January press release, is headed into a new pivotal Phase III according to a May press release.

EyeGate Pharma's EGP-437 has completed a Phase III trial as of April, according to clinicaltrials.gov.

Ista's Remura (low dose Bromfenac) is in a Phase III presently, with results expected the latter half of this year according to the manufacturer's pipeline page.

Can-Fite Biopharma / CF-101: Oral A(3) adenosine receptor agonist. Approved for entering Phase III on Sept 5 2010 but not yet recruiting according to clinicaltrials.gov.

Allergan: Clinicaltrials.gov lists "EDNP" i.e. "eye drop new platform" in Phase III (being compared to Refresh) - and since the primary endpoint being evaluated is symptoms (OSDI) this is probably an OTC but that isn't quite clear. Allergan's site lists Restasis X in Phase II but no recent information on that at all.

ALCON: (1) DUREZOL: According to clinicaltrials.gov, Durezol is in a Phase II looking at its use specifically as an anti-inflammatory in dry eye patients. (2) ESBA105 (from acquisition of ESBATech in 2009), a biological, for severe dry eye, was added to clinicaltrials.gov in April 2011. (3) AL38583 (cyclosporine .05% or .10%) completed a Phase II last year but there hasn't been a peep out of it since then. Dark horse or dead in the water? Your guess is better than mine. (4) A last note on ex GSK Cilomilast and/or AL43546 - I don't know what's going on with these if anything (probably nothing) but I will drop these from the roster if I don't hear pretty soon.

Mimetogen / MIM-D3: Phase II ongoing, started recently.

SARCODE SAR1118: More data presented at ARVO in May 2011. Presumably this is from the study that was completed about this time last year.

SANTEN / DE110: Added to list May 2011 based on clinicaltrials.gov listing. Not sure what this is.