“A novel therapeutic drug that protects and regenerates corneal nerves in ophthalmic diseases” See 12/2018 press release
Cannabinoid drug for neuropathic pain and inflammation. According to Novaliq’s pipeline page, they filed an IND in 1Q 2018. The most recent announcement online about the intent to develop this technology seems to still be from spring of 2017, so it’s not clear whether this is still happening.
Cannabinoid receptor type 2 (CB2R) agonist. Haven’t seen any recent clinical data and it’s not listed on the company’s pipeline page, but according to 2018 financials, it’s still being studied.
Adiponection peptide for reducing inflammation and accelerating epithelial healing. According to Allysta, intending to start clinical trials in 2019.
ANDROGEN EYEDROPS (ALLERGAN)
This has been in development multiple times over the years and showed great promise; androgens play a role in both lacrimal and meibomian gland secretion. Many doctors prescribe compounded testosterone creams for the eyelids for certain patients. I have not seen this listed in Allergan’s pipeline recently but they appear to have relevant patents (examples here and here) so I am keeping it on the list.
“Therapeutic lipid”, claims to have both therapeutic and lubricating effects. See website.
AZR-MD-002, 007 (AZURA)
For MGD, blepharitis. Website
Phase 2 Clinical Trials
ECF-843 / Lubricin (Novartis)
In April of 2017, Novartis exercised an option to license Lubricin (now known as ECF-843) from Lubris Biopharma after clinical trial results were published. I haven’t seen any news since then and am anxious to see progress on this very promising drug. Their 2017 annual report lists the intended filing date as >/= 2022.
Narrow spectrum kinase inhibitor. Phase 2 trial results published in Clinical Ophthalmology in Feb 2019.
Recombitant nhuman nerve growth factor. Currently approved (US, Europe) for neurotrophic keratitis, and being studied for dry eye.
This drug targets MGD and evaporative dry eye and utilizes EyeSol drug delivery technology. Results were announced from a Phase 2 trial in October 2018. More data at ASCRS 2019, and expected to enter Phase 3 in 2019.
Selective TRPM8 agonist “Novel, ocular neurosensory drug therapy” currently in Phase 2 clinical trials.
Retinoic acid receptor gamma (RARγ) agonist. Initiated clinical trial in 2018.
OC-01, OC-02 (Oyster Point)
Nasal sprays to increase tear production. Recently completed clinical trial, data presented at ASCRS 2019. Expected to enter Phase 3 in 2019.
Topical dry eye treatment for post menopausal women.
Lipid layer stabilizer for EDE/MGD patients.
DEXTENZA (OCULAR THERAPEUTIX)
This has been approved for post-operative ocular pain, and they are seeking approval for chronic allergic conjunctivitis
Topical small peptide integrin inhibitor in HA base. Secondary Phase 2 to be presented at AAO 2019.
DNASE (university of illinois)
Recombinant Deoxyribonuclease - cystic fibrosis drug being studied for severe dry eye. Phase I/II published May 2019.
For MGD/evaporative dry eye. Website
Phase 3 Clinical Trials
Currently recruiting for Phase 3 clinical trial. Presented poster at ARVO 2019 with promising results.
Formerly known as ADX-102. This drug seems to be moving along rapidly. Phase 2a trial results announced in 9/2017, followed by 2b news in 10/2018 and now from a recent news release it seems that Phase 3 trials are ahead of schedule (company’s pipeline page says 2019).
For dry eye and neurotrophic keratitis. Conducting additional clinical trials.
Also known as SKQ1. “Novel small molecules engineered specifically for reducing oxidative stress within the mitochondria” for patients with moderate to severe dry eye disease. Started Phase III trial October 2018.
“OcuNanoE” formulation of preservative-free brimonidine tartrate 0.2%, currently in phase 3 trials.
Brimonidine tartrate again, but with an orphan drug designation specifically for ocular GvHD to fast-track the review process.
Cyclosporine .05% and 0.1%, targeting moderate to severe dry eye. Announced results from Phase IIb/III clinical trials in October 2018. Starting confirmatory trial in 2019.
0.25% for temporary relief of dry eye. NDA submitted in Oct 2018. Announced results from two Phase 3 clinical trials in Jan 2018. (Not to be confused with 1% drug for post-surgical pain, recently approved as Inveltys.)
Tivanisiran, targeting reduction of pain and clinical signs of dry eye. Finished recruiting for current clinical trial in Oct 2018, expecting results 2Q2019.
There are an awful lot of drugs that get developed… and this is a good thing. However, it’s difficult to keep tabs on current status. Generally, if I don’t see any public sign of activity on a drug for two years or more, I’ll drop it from the list unless I feel particularly confident from information received that it is still a strong contender for current or future development.
If you see anything inaccurate, missing, or needing updating, I welcome all input so long as it can be substantiated with information available to the public.
MIM-D3 (Tavilermide) - Mimetogan/Allergan. Last heard of completing Phase III clinicals, early 2017. Not showing on Allergan’s pipeline at present though.