Clinical Trials of Dry Eye Drugs

Click here for the FDA's list of actively recruiting dry eye clinical trials. (Note that most of these are for products that are already on the market.)

Last updated: 1/28/2009

INSPIRE/"PROLACRIA" (DIQUAFOSOL TETRASODIUM): (Last update Jan 2010) Dead, after a prolonged and valiant struggle for better clinical results.

Currently in Phase III

NOVAGALI/CYCLOKAT: (Latest news April 2009) Formerly NOVA22007. Cationic emulsion formulation of cyclosporine. Announced successful Phase IIs on April 15 2009 (click here for press release) and at that time said they expected to have results from Phase III in US in 4Q 2009. Phase III also underway in Europe. See also Novagali's pipeline status page.

ALCON/ZYCLORIN (FORMERLY SIRION/ST-603): (Last update Jan 2010) This is a topical cyclosporine A (0.1%) drug "delivered by way of Sirion's Sophisen system, which deploys a polydisperse solution as a carrier". According to Sirion's pipeline page and recent news reports about the Alcon acquisition, it is in Phase III. According to the NIH clinical trials site, a study was completed in 2008.

Completed Phase II

RESOLVYX / RX-10045 (Latest news Aug 2009) The anti-inflammatory agent RX-10045 from Resolvyx has successfully completed Phase I/II in 08/2009. Click here for most recent Resolvyx press release. The drug is now scheduled to enter Phase III in the first half of 2010.

ISTA / LOW DOSE BROMFENAC: (Latest news Nov 2009) Ista announced on June 8th "positive results from a proof-of-concept Phase 2 clinical study in subjects with dry eye disease" using low-dose Xibrom. Click here for June news report. The link to this drug on ISTA's pipeline page appears to be broken. In ISTA's 3Q 2009 results, they said they expected it to enter Phase III in 1Q 2010.

ISTA/ECABET SODIUM: (Latest news Jan 2009) Mucin secretagogue. Final Phase IIb clinical trial results announced Jan 2009 with positive trends in TBUT and Schirmer (in contrast with results back in 2007 that improved one sign and two symptoms). Click here for Jan 2009 press release. While initially expected to proceed to Phase III in 2010, an investor report stated ISTA has opted to move low-dose bromfenac (above) into Phase III instead, so this project may be on ice at present.

CAN-FITE/BIOPHARMA/CF-101: (Latest news May 2009) Positive results from Phase II were announced in May 2009 (click here for press release). Autoimmune patients might be interested that they observed improvements in rheumatoid arthritis patients' dry eye symptoms in a separate trial. I have seen no indication of timing for any next steps on this drug yet.

EYEGATE PHARMA / EGP-437: (Latest news June 2009) This is a drug/device combo, a corticosteroid delivered by the EyeGate® II Delivery System. Completed Phase II March 09 and announced results in June. No news since then on next steps.

ALACRITY BIOSCIENCE/ALTY-0501: (No news in 2009) Non-antimicrobial topical doxycycline product. Successfully completed Phase II in 2007 but no indication of having entered Phase III. Alacrity's outdated web page says it was scheduled to start in 2008.

In Phase II

OTSUKA-ACUCELA/REBAMIPIDE (Last update December 2009) FINALLY, after a long long silence there is news. Rebamipide is re-starting Phase II trials, after a long but botched Phase III (eventually terminated by Novartis) drove Otsuka to another partner. Click here for the clinical trial link.

ALLERGAN / RESTASIS X: (No news) Listed as Phase II on Allergan's pipeline page.

ALCON / X: (Last news May 2009) Alcon has something cooking, suspected to be a cyclosporine drug according to investor reports. Large Phase II trial listed at clinicaltrials.gov.

MACUSIGHT / PERCEIVA: (Added to roster Nov 2009) Perceiva (ocular sirolimus product) is currently in 4 separate Phase II trials with different indications one of which is dry eye. Click here for an October news report and click here for Macusight's pipeline page. Expecting clinical data 1Q 2010.

SARCODE / SAR1118: (Last news June 2009) Antiinflammatory. SarCode's website says this is in Phase I but so many of these companies never seem to update their websites! ClinicalTrials.gov states it is in ongoing Phase II trial but no longer recruiting.

ALCON AL-43546: (No news in 2009) This HLA drug is listed on Alcon's pipeline page (no new information for 2009) and clinicaltrials.gov indicates a Phase II clinical is ongoing and recruiting "by invitation only".

OPKO/CIVAMIDE: (No news in 2009) Proprietary TRPV-1 receptor modulator and neuronal calcium channel blocker. Um... let me rephrase that. Intranasal application of some kind of arthritis cream. I have not been able to confirm whether they've actually started Phase II yet. Opko's ophthalmics web page says Phase II was to start in 2h 2009, and I found an investor presentation (see p. 16) that indicates Phase II is ongoing.

LANTIBIO / LANCOVUTIDE (formerly MOLI1901): (No news in 2009) Cystic fibrosis drug being attempted as a dry eye treatment. Lantibio website still says it's currently in Phase II in the US but they're either taking their sweet time about it or the project is on ice.

ALLERGAN / ANDROGEN TEARS: (No news) Listed as Phase II on Allergan's pipeline page. There's no way this has been in Phase II this long though. On ice, presumably, till they're ready to dust it off and try again?

Pre-clinical or unknown status

MIMETOGAN / MIM-D3: (Last news May 2009) Mucin secretagogue. Pre-clinical data was presented at ARVO in May 2009 and the drug was expected to enter toxicology and safety studies within the year. Click here for most recent press release.

SYLENTIS / Ocular pain drug: (Last news May 2009) Sylentis are developing a drug for ocular pain associated with dry eye and presented results at ARVO 2009. See news report.

LUX BIOSCIENCES / LX214: (Last news Sept 2009) Voclosporin. Completed Phase I and looking for a partner. See Lux website and September press release.

LUX BIOSCIENCES / LX212: Preclinical polymer implant containing voclosporin. See Lux website.

ARGENTIS / ARG101: (No news in 2009) Testosterone cream or gel treatment targeted at menopausal women. Currently expected to start Phase I/II process in 2010 which is about 2 years behind the timeline posted earlier. Click here for Argentis' pipeline page.

ARGENTIS / ARG102 and ARG103: (No news in 2009) Both preclinical. These are two more SCCO-developed hormone therapies (see ARG101 above) with target Phase I/II trials starting in 2011 and 2012 respectively. ARG102 is a progesterone targeted at men and younger women and ARG103 is a combined testosterone/progesterone drug. Click here for Argentis' pipeline page.

REGENERX/RGN259: (No news in 2009) In preclinical study for various indications. Corneal wound healing study terminated due to slow recruitment but remaining indications include recurrent corneal erosions and Sjogrens dry eye. Here's their pipeline page.

EYERX RESEARCH /LACRITIN: (No news in 2009) Nothing available at the moment but a blurb on EyeRx's website.

ZYMEDIS says they're developing a cyclosporine Restasis competitor. Patent pending. See Zymedis' website.

GRAVEYARD?

These drugs have been silent for awhile so this is the last time I'll mention them until & unless they reappear in the news.

DAIICHI SANKO / Rivoglitazone (DE011) This was once reported as a diabetes drug that Sankyo and Senju were collaborating on developing into a drug for "epithelial disorders including dry eye" but it is no longer listed on either company's pipeline pages.

DYNAMIS THERAPEUTICS / DYN15: I ran across this somewhere in 2008 and can't find any more information except that it's apparently been licensed to Rohto to develop. Per Dynamis' website: "Dynamis' lead drug candidate, DYN 15, prevents the formation of 3DG and lowers the levels of several key cytokines that are stimulated in chronic inflammation."

ALCON/LANTIBIO/VISMED(R): I don't know what's going on with this. It's on the market in Europe but not approved in the US and I have seen no recent information about whether they've re-started Phase IIIs in the US.

ALCON / AL-2178 Rimexolone (Vexol), a corticosteroid, at one point was showing on Alcon's pipeline for 2009 FDA submission for the indication of dry eye. Click here for patent application. Haven't found any recent info.

HOLLES LABS/DEHYDREX Specialized clinical trial for recurrent corneal erosion patients only (orphan drug / compassionate use program). This is still listed as recruiting for the trial, but no information for a long time.

NASCENT/ iDESTRIN (NP50301): Estrogen ester compound (topical eyedrop). Phase IIb clinical completed. No news in about 3 years and Nascent's website seems to have disappeared, so I think we're past due for an epitaph.

Are we missing anything? Email it to us at bulletin@dryeyecompany.com.