Dry Eye Drug Pipeline

Please contact Dry Eye Foundation with additions, updates or corrections.

Updated July 2023

NDA submitted

This is a list of drugs for which the “New Drug Application” (NDA) - or, in the case of a biologic, “Biologics License Application” (BLA) has been submitted and the company is waiting for the FDA to make a decision. NDA is the last step in the process and it means that the company has completed all of the required human clinical trials under the agency’s oversight and are awaiting final review and, hopefully, approval.

REPROXALAP (Aldeyra)

0.25% topical ocular reproxalap (RASP inhibitor; “rapid onset”) for dry eye disease. NDA filed November 2022.

Phase 3 clinical trials

This is a list of drugs with active Phase 3 human clinical trials.

AR-15512 (Aerie/Alcon)

“The active ingredient in AR-15512 is a proprietary small-molecule selective agonist of the transient receptor potential melastatin 8 (TRPM8) cold thermoreceptor, which represents a novel therapeutic target for dry eye.” Fast-acting. Announced acquisition by Alcon in 8/22/22 press release.

PL9643 (Palatin)

MCr agonist. Results from Phase 3 trial expected 1H2023.

ALY-688 (Allysta)

Adiponection peptide for reducing inflammation and accelerating epithelial healing. In Phase 2b/3 clinical trials.

HBM-9036 (Harbour biomed)

Tanfanercept ophthalmic solution. Previously HL-036 (Hanall). Most recent news (intermin Phase 3 results) 1/13/22 press release.

SKQ-1/VISOMITIN (Mitotech)

Mitochondria-targeting cardiolipin peroxidation inhibitors. For patients with moderate to severe dry eye disease. No news since VISTA-1 and VISTA-2 trials were completed, but a February report suggested new trials (VISTA-3 and VISTA-4) were expected to begin in the 2nd half of 2022 and the Mitotech website indicates they are in Phase 3.

Drugs in Development

This is a list of drugs believed to have been in active development within the past twelve months.

YP-P10 (Yuyu Pharma, Inc.)

Immunomodulatory ophthalmic solution being studied to treat the signs and symptoms of dry eye. Phase 2 clinical trial active. More information on clinical trial.

SAF-312 (Novartis)

This is the first drug we’ve seen in Phase 2 clinical trials for ocular surface pain, a significant development for our community. More information on the trials.

AZR-MD-001 (AZURA) - Phase II

Azura is developing a series of drugs for lid margin disease. AZR-MD-001 is the furthest along and they are studying it for MGD, contact lens intolerance and evaporative dry eye. Results from a Phase 2 study were published in The Ocular Surface in July 2023.

A197 (Aramis)

For treatment of dry eye disease. Currently recruiting for Phase 2 clinicals. Last press release 1/11/22 (IND announcement).

GLK-301 (Glaukos)

Topical pilocarpine cream applied to eyelids to relieve DED signs and symptoms. Awaiting results from Phase 2 trials.

ST266 (Noveome)

ST266 is a placental-derived product being studied for persistent epithelial defect (PED) by Noveome Biotherapeutics. According to clinicaltrials.gov, a Phase 2 clinical trial is ongoing.

TTBT01 (Bio-Tissue)

3/1/21 press release says “TissueTech (Bio-Tissue’s parent company) has received clearance for Phase 2 study of “morselized Cryopreserved Amniotic Membrane (CAM) and Cryopreserved Umbilical Cord (CUC)”. We understand a clinical trial is ongoing, though it is not listed at clinicaltrials.gov.

Status unknown

We haven’t had any news about these ones in quite awhile, but

ST-100 (Stuart)

Last news 1/3/22 press release after completion of Phase 2 trials.

RGN-259 / GBT201 (Regenrx)

Last press release 5/14/21. At that time, they were looking at pivoting from neurotrophic keratopathy to dry eye disease with combined data from three clinical trials.

K-161 (KOWA)

Last known to be in Phase 3; no longer on Kowa website.

SURF-100 (Surface Ophthalmics)

No news since initial clinical trial. There was also a SURF-200 for episodic dry eye.

Lacripep (Tear Solutions)

Lacripep is a synthetic tear protein dry eye treatment.

Editor’s notes

Many drugs get developed and naturally not all make it to market. Generally, if we do not see any public sign of activity on a drug for 18 months or more, we remove it from the list of drugs in development.

Please contact the Dry Eye Foundation with news reports or other information that should be reflected in this list.