The FDA has reportedly cleared Cloudbreak Pharma Inc.’s investigational new drug (IND) application for CBT-199, an investigational topical ophthalmic emulsion under clinical development for presbyopia.
First, a look at this company.
Incorporated in the Cayman Islands, the clinical-stage ophthalmic drug developer has its U.S. headquarters in Irvine, California, under the name ADS Therapeutics LLC (its wholly-owned subsidiary).
Its focus: Developing pipeline candidates targeting anterior- and posterior-segment ocular diseases, including juvenile (pediatric) myopia, meibomian gland dysfunction (MGD), presbyopia, and vascularized pinguecula.
- See here for a full look of assets and their respective ophthalmic disease indications.
Wasn’t Cloudbreak in the news recently?
Fairly recently, yes … but in regards to another candidate (CTB-104, its lead asset) and its potential to become the first and only treatment for pinguecula.
We last reported on Cloudbreak’s successful end-of-phase-2 meeting with the FDA in December 2025—and the company shared plans late last month to advance to a phase 3 program.
Now focus on this presbyopia candidate.
CBT-199 is a novel topical ophthalmic emulsion currently under clinical investigation through ADS Therapeutics.
What to know about it: The drop contains a parasympathomimetic miotic agent that stimulates the parasympathetic system to induce pupil constriction (miosis).
- This pupil constriction creates a “pinhole” effect to increase depth of focus, improving near vision without changing lens elasticity.
Talk about its formulation.
CBT-199’s proprietary, non-aqueous (water-free) formulation is designed to improve drug stability by preventing decomposition of its (currently unidentified) active ingredient.
- To note: Stabilizing the drop’s active ingredient is intended to limit degradation, preserve its effectiveness, and ensure its safety through its intended shelf-life.
The intent: “To provide a comfortable, soothing dosing experience in a consumer-friendly self-preserved multi-dose bottle with long-shelf life,” according to Cloudbreak, in its December 2025 announcement of the IND submission—via ADS Therapeutics—to the FDA.
And this IND clearance?
Securing IND clearance is the first step toward initiating U.S. clinical trials on CBT-199.
With this, Cloudbreak (via ADS) is now free to advance the presbyopia eye drop into a phase 2 clinical program, with the end goal of pursuing potential regulatory approval.
So what do we know about the phase 2 program?
No details have been released at all regarding any trial design / setup, a start date, or an anticipated topline data readout.
On the clinical data front: Cloudbreak only shared that the IND application was submitted with pre-clinical animal safety and tolerability data to support human testing.
Okay … so what do we know?
About CTB-199? Not very much … we’ll just have to stay tuned.
In the meantime, however: The phase 3 clinical program on CBT-001 (that investigational pterygium asset we mentioned earlier), is expected to kick off in Q1 2027.