Clinical Trials of Dry Eye Drugs

Click here for the FDA's list of actively recruiting dry eye clinical trials.

Last updated: 8/30/2010

In or completed Phase III

INSPIRE / DIQUAFOSOL (Updated Aug 2010). According to an 8/25 news report Inspire are finally pulling the plug on efforts to get this approved in the US. It was recently approved in Japan and is being marketed there by Santen under the name Diquas.

EYEGATE PHARMA / EGP-437: (Updated Aug 2010) This is a drug/device combo, a corticosteroid delivered by the EyeGate® II Delivery System. Phase III trial launched June 2010.

NOVAGALI/CYCLOKAT: (Latest news April 2009) Formerly NOVA22007. Cationic emulsion formulation of cyclosporine. Announced successful Phase IIs on April 15 2009 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. Website currently just showing it in Phase III.

Completed Phase II

ALCON / 38583 (formerly "X"?): (Last news March 2010) This drug has been suspected to be a cyclosporine drug according to investor reports. Large Phase II trial listed on clinicaltrials.gov as being complete in March 2010. How that relates to the Zyclorin acquisition... ya got me.

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. At this point (March 2010) there's no firm information about it having commenced Phase III so I'm moving it back tentatively one notch to completed Phase II. Wondering in fact how it relates to Alcon X.

ALCON AL-43546: (Latest news Jan 2010) This HLA drug is listed on Alcon's pipeline page and clinicaltrials.gov now indicates a Phase II clinical has been completed. An analyst report on ACL in Apr 2010 indicates Phase I/Phase II status as well.

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 Aug 2010) Expecting Phase III to commence imminently.

ISTA / ECABET SODIUM: (Latest news March 2010) Backburnered in favor of low-dose bromfenac (above).

CAN-FITE / BIOPHARMA/CF-101: (Latest news Apr 2010) Oral A(3) adenosine receptor agonist. A study was published in March 2010 with results from last year's Phase II trial. Here's the abstract. As of March 2010 they finally updated their web page but only to indicate that they are "in planning" for Phase IIb.

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.

SARCODE / SAR1118: (Last news May 2010) Antiinflammatory. SarCode has completed Phase II according to ClinicalTrials.gov. A May 3 2010 press release reported results from the Phase II study.

In Phase II

ALCON / CILOMILAST: (Added Apr 2010) Acquired from GSK in late 2008. Phosphodiesterase IV inhibitor. Reportedly "Phase I/Phase II".

INSPIRE/AZASITE (for blepharitis): Listed on Inspire's pipeline.

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.

REGENERX/RGN259: (Updated Aug 2010) Here's their pipeline page. Currently in physician-sponsored Phase II trial for GVHD dry eye.

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

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.

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?

MASS EYE & EAR / IL-1-Ra (Added Apr 2010) For MGD. Listed on clinicaltrials.gov as Phase I/Phase II (recruiting), and on MEE's page. Results reportedly to be published in spring of 2011.

THEA PHARMA / AZYTER (Added Apr 2010) Not yet started recruiting. Here's a link to the clinical trial page.

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.

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

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.

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