In its latest dry eye disease (DED)-focused partnership, Eyenovia, Inc. and Formosa Pharmaceuticals, Inc. have agreed to co-develop Formosa’s clobetasol propionate ophthalmic solution (0.05%), intended to provide short-term DED relief.
Sounds like Eyenovia’s been busy …
Indeed it has. Just in the last few weeks, the New York-based, late-stage ophthalmic pharmaceutical company announced two DED collaborations:
- With Senju Pharmaceutical Co. Ltd to develop a potential new chronic DED treatment featuring the companies’ proprietary technology (Optejet, but more on that later) and corneal epithelial wound healing candidate, respectively.
- With SGN Nanopharma Inc. to develop and validate a novel drug-device combo involving Eyenovia’s Optejet dispenser and SGN’s proprietary platform-based cyclosporine formulation.
Gotcha. Now refresh me on Formosa.
The Taipei City, Taiwan-based clinical stage biopharmaceutical company is developing pipeline ophthalmic assets in the following therapeutic areas: ophthalmology, oncology, and the anti-infective space.
- Key to these investigational candidates: A proprietary nanoparticle formulation platform technology referred to as APNT, designed for topical, oral, and intranasal administration.
Talk about this platform.
Formosa’s APNT nanoparticle formulation platform targets reducing particle sizes in order to potentially improve dissolution and bioavailability as well as provide a stable formulation—all with a lower risk of contamination.
Click here to watch a video on this.
Alrighty, now let’s discuss this candidate.
Clobetasol propionate (known as APP13007) is a novel aqueous nanosuspension formulation containing corticosteroid clobetasol propionate (0.05%).
Previously FDA-approved in March 2024 for the treatment of postoperative inflammation and pain following ocular surgery, the solution is:
- The first product developed using Formosa’s APNT platform
- Formulated with a proprietary homogeneous nanosuspension and solution-like appearance
- Designed to provide eye comfort and possibly enhance drug penetration into ocular tissues
And its dosing schedule?
The solution’s DED-indicated dosing has not yet been specified; however, its schedule for postop inflammation and pain is:
- Dosed twice daily (BID) for 14 days
Speaking of that previous indication …
To note: Formosa already owns the exclusive U.S. rights to this candidate.
- Read our coverage of its purchase in August 2023, which clocked in at a potential $86 million.
Also: The companies previously agreed (in February 2023) for Eyenovia to test clobetasol propionate with its Optejet dispenser (see below for details) and for both companies to participate in an FDA consultation meeting to discuss DED indications.
So how will this DED indication be different from its previous one?
A key unique component to the solution will involve its dispersion using Eyenovia’s Optejet device, exclusively designed for ocular therapeutics as a way to precisely dispense topical eye medications.
How it does this: By using Eyenovia’s Microdose Array Print (MAP) technology as a topical delivery system, which is similar to an inkjet printer.
- The process: Medication is dispensed horizontally in a mist, coating the surface of the cornea.
- Note: Contact to the eye occurs at a low velocity in order to reduce ocular impact.
And for chronic medications: The device is intended to ensure patient adherence while providing real-time data to a physician.
Nice! Is there any clinical data on the solution?
Yes … but not for DED. Clobetasol propionate was previously studied in two phase 3 pivotal trials (NCT04739709)(NCT04810962) to support its recent FDA approval.
The crux of those findings: The formulation met its primary endpoints by providing a rapid and sustained clearance of ocular inflammation and pain—statistically and clinically superior to the placebo—and was well-tolerated.
Now the money question.
What to know: The companies reported they’ll be sharing the development costs and division of profit once clobetasol propionate is commercialized.
Lastly, any expert input on the potential of this solution?
Eyenovia CEO Michael Rowe noted that its unique profile that lends itself to exploring its use in dry eye.
“The drug’s efficacy in pain and inflammation relief as well as its low incidence of adverse events could one day be a boon to the millions of dry eye patients who suffer from periodic flare-ups of the disease,” he stated.