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.)

BELOW: Status updates for drugs in clinical trials and for promising research expected to eventually enter clinical trials as dry eye treatments

Phase III

NOVAGALI/CYCLOKAT: (Updated April 2009) Formerly NOVA22007. Cationic emulsion formulation of cyclosporine. Announced successful Phase IIs on April 15 2009 (click here for a report). Expected to complete Phase III in US in late 2009. Phase III underway in Europe.

OTSUKA-ACUCELA/REBAMIPIDE (Updated May 2009) Novartis terminated this project last year. Later, Otsuka announced a new partnership with Acucela and they are pushing ahead to hopefully get this on the US market. According to a blurb in an unrelated article in May 09 it's currently in Phase III trials.

HOLLES LABS/DEHYDREX (Last update Dec 2007) Specialized clinical trial for recurrent corneal erosion patients only (orphan drug / compassionate use program). Recently completed Phase III clinicals and expected to file NDA soon.

LANTIBIO/VISMED(R): (Last update Oct 2007) Lantibio and TRB Chemedia initiated Phase III clinical trials of their sodium hyaluronate drop Vismed(R) in January. Alcon recently closed a deal to market this product in the US. Haven't seen any prelim study results yet. No links, this seems to be right under the radar, but if you google Lantibio and Alcon you'll find the transcript of Alcon's conference call that mentions their deal.

SIRION/ST-603: (Last update May 2007) Sirion Therapeutics announced May 1 that it was starting Phase III clinicals on its cyclosporine dry eye therapy ST-603. Click here for press release.

Phase II

ISTA / XIBROM: (Added 06/2009) Ista announced on June 8th " ositive results from a proof-of-concept Phase 2 clinical study in subjects with dry eye disease" using low-dose Xibrom.

CAN-FITE/BIOPHARMA/CF-101: (Updated 06/2009) May 2009, announced positive Phase II results.

EYEGATE PHARMA / EGP-437: (Updated June 2009) This is a drug/device combo, a corticosteroid delivered by the EyeGate® II Delivery System. Completed Phase II March 09. Positive results announced May 2009.

INSPIRE/"PROLACRIA" (DIQUAFOSOL TETRASODIUM): (Last update Feb 2008) Prolacria failed FDA approval 3 times and has since gone back to do more clinicals. According to the Feb 26th investor call, they are now focusing "on evaluating the effects of Prolacria on the central region of the cornea as measured by fluorescein staining scores". They are actively enrolling patients in a pilot trial. Next news expected in Q3 of 2008. - Per a 6/08 press release, Inspire expects to file for approval in Japan by the end of June.

OPKO/CIVAMIDE: (Last updated Sept 2008) Proprietary TRPV-1 receptor modulator and neuronal calcium channel blocker. Um... let me rephrase that. Intranasal application of some kind of arthritis cream. Scheduled to start Phase II clinicals in late 2008 or early 2009 according to a Sept 8 interview with EVP Samuel Riech.

ARGENTIS/ARG101(T) and ARG1012(P):(Updated 5/2008) According to Argentis' pipeline page these two therapies are scheduled for Phase I/II clinicals in 2008. Exact status unknown. Click on link and then on "Ocular" tab for more details of the drugs themselves. They are both for transdermal delivery of the active ingredient through application of a cream or gel formulation to the upper and lower eyelids. ARG101(T) is a testosterone cream or gel formulation used to treat DES in menopausal women. ARG102(P) is a progesterone cream or gel formulation used to treat DES in men and younger women.

ALCON / AL-2178 (Last update 12/2007) Rimexolone (Vexol), a corticosteroid, is showing on Alcon's pipeline for 2009 FDA submission for the indication of dry eye. Click here for patent application.

SENJU-ISTA/ECABET SODIUM: (Last update 5/07) Mucin secretagogue. Preliminary Phase IIb clinical trial results announced 5/07 with positive trends in one sign and two symptoms. Click here for press release.

ALACRITY BIOSCIENCE/ALTY-0501: (Last update Oct 2007) Non-antimicrobial topical doxycline product. Announced some positive results from Phase II clinical trials on Oct 9th. Click here to download PDF press release.

NASCENT/ iDESTRIN (NP50301): Estrogen ester compound (topical eyedrop). Phase IIb clinical completed, now all we need is money to move forward. Latest report was more than a year ago - early January 2006 (click here for press release) stating good results from Phase IIb with "no drug related serious adverse effects". Click here for Nascent's page.

LANTIBIO/DURAMYCIN (MOLI1901): (No recent updates) Cystic fibrosis drug being attempted as a dry eye treatment. Currently undergoing Phase II trials in the US following positive results in european Phase I studies.

BROKEN LINK Click here

On the horizon / Preclinical

TREHALOSE

SARCODE / SAR1118: (Added May 2009) Antiinflammatory. Announced Phase I results March 30, 2009 (click here for report) and expecting to start dry eye Phase IIs this year.

MIMETOGAN / MUCIN SECRETAGOGUE: (Added Oct 2008) From their website: "In dry eye, we have developed two families of small molecule compounds that have extremely robust mucin stimulating properties. Mucin has long been known to be one of the components of the tear film that is found to be reduced in dry eye patients. A lead compound for this disease is currently being chosen and it is expected that clinical trials will commence in 2009."

LUX BIOSCIENCES / LX212 AND LX214: (Last update 6/2009) Spotted in a news report spring 2008. In July at ARVO 08 they announced preclinical results for LX214, a calcineurin inhibitor Lux " is developing as a potential treatment for such conditions as dry eye syndrome, blepharitis, and atopic keratoconjunctivitis". Click here for 7/31/08 press release on LX214. LX212 is more of a distant possibility as a severe dry eye treatment at this point. See the following links on Lux' website for LX212 and LX214. 6/09 UPDATE: Brief blurb in a news report says LX214 is now in Phase I clinicals.

ARGENTIS / ARG103:(Added 5/08): Another SCCO development for Argentis (see 101 and 102 above), this one is a combination testosterone and progesterone which they are hoping can be effective with a wider patient base. Click here for Argentis' pipeline page.

RESOLVYX / RX-10045 (Last update 4/08) Bedford MA pharmaceutical doing Omega 3 research says they will be testing this drug in 2008 for dry eye. Click here for news report.

DYNAMIS THERAPEUTICS / DYN15: (Last update 3/08) Spotted on the net. "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."

DAIICHI SANKO / Rivoglitazone (DE011) (Last update 12/2007) Not quite sure what stage this is in. It's a diabetes drug that Sankyo and Senju are collaborating on developing into a drug for "epithelial disorders including dry eye".

REGENERX/TB4: (Added Nov 2007) Newly patented investigational product for "reversing or inhibiting eye degeneration associated with dry eye syndrome" including, they claim, in LASIK and PRK patients. Click here for a Nov 5 2007 news story.

OPHTALMIS MONACO/OPH-01 "A new pharmacological approach involving the permeability of the corneal epithelium", this is being developed for dry eye, ocular inflammation and ocular allergy, and the first application is expected to be a preservative free drop for dry eye. Click here for Apr 2007 press release.

Pericor/PCS101:A press release by Pericor Science said "The Company gained validation of its technology when PCS 101 for Dry Eye was licensed to a major pharmaceutical company in 2005". What is it and why haven't we heard anything about it? They did not respond to our enquiries. Anyone with info please let us know, assuming of course it's good enough to care about.

EVOLUTEC/REV131 (No recent updates):This drug is currently in a Phase IIb trial for allergic rhinitis and was scheduled to begin trials for asthma and for dry eye in early 2007.

SENJU/LACRITIN: (No recent updates) It's very early stages yet but we've been keeping an eye on this for well over a year and think it's one of the most interesting and promising things coming down the pipeline. Some results of rabbit eye studies presented at ARVO recently. Click here for some updates & abstract from ARVO posted in Dry Eye Talk.

OTHERA/OT-551: (No recent updates) This is in Phase II clinical for preventing cataracts in patients who have undergone vitrectomy. Othera has stated they expect to begin Phase II clinicals for two additional indications, AMD and dry eye syndrome, next year. Click here for more.

PAI-2: (No recent updates) Research being done at University of Pennsylvania and Temple University; data presented at ARVO recently. Not a whole lot of info but it sounds interesting. Click here for more.

Dead

NOVARTIS / PIMECROLIMUS (AMS981)

Are we missing anything? Email it to us at news@dryeyezone.com.