New findings published in Cornea reveal 52-week data on Harrow’s VEVYE (cyclosporine ophthalmic solution) 0.1% from the ESSENCE-2 phase 3, open-label extension (OLE) clinical study.
First, a refresher on VEVYE.
Commercially launched in the United States in January 2024, VEVYE was FDA approved in June 2023 as the first and only cyclosporine solution indicated for the treatment of dry eye disease (DED).
- Fact: It was originally developed by Novaliq GmbH before being acquired by Harrow in July 2023.
Give me its clinical details.
Pronounced vee-vye, the cyclosporine formulation is solubilized in a novel, water-free excipient—with no antimicrobial preservatives, oils, or surfactants—and designed to specifically meet unfulfilled requirements of DED.
- Plus: Due to no pH or osmolarity characteristics, the calcineurin inhibitor immunosuppressant is meant for topical ophthalmic use.
- As a bonus: See here for details on this water-free technology (hint: it involves ultrapure semifluorinated alkanes [SFAs], which have very low surface tension and viscosity and enable improved visual clarity).
How does it work?
One drop of VEVYE is intended to be instilled twice a day (BID) in each, an estimated 12 hours apart, according to its prescribing information (PI).
- The expected result: VEVYE can exhibit an increased residence time on the ocular surface and allow for a high bioavailability within the target tissues to release the solution’s fast onset of action within 2 weeks.
And its efficacy?
Based on supporting clinical data from two phase 3 studies—see here and here—the solution was found to demonstrate efficacy at 4 weeks.
Nice! Now explain this extension study.
First: The new data is from an OLE study of the prospective, multicenter, open-label, phase 3 ESSENCE-2 clinical study that evaluated VEVYE.
- The setup: A total of 202 DED patients (previous participants of the original ESSENCE-2 study) received VEVYE in both eyes, BID, for 52 weeks.
And what was measured?
The following endpoints:
- Primary safety = ocular and nonocular adverse events (AEs)
- Secondary safety: visual acuity (VA), biomicroscopy, intraocular pressure (IOP), and dilated fundoscopy
- Efficacy: corneal fluorescein staining (tCFS) score, ocular symptoms (visual analog scale [VAS]); and Schirmer tear test
What were the findings?
By Week 52, 86.6% (175) of participants completed the extension study.
Out of that number:
- 27.5% (55 patients) reported 74 ocular treatment-emergent AEs (TEAEs)
- Most common:
- Instillation site pain (6.5%; n = 13), mild intensity
- Reduced VA (3%; n = 6)
- Note: One patient withdraw due to an ocular AE of mild burning/stinging
- Most common:
Plus: A statistically significant improvement was noted among patients in “all prespecified efficacy endpoints compared with baseline at each visit,” according to the data.
Now into specifics…
Also observed were early improvements in corneal staining, which stabilized over time, while tear production improved continuously, the authors reported.
Bonus: Symptoms improved as a result of these effects, “with scores reaching a minimum after 1 year of treatment.”
Any patient-reported feedback?
Yes! When asked to rate (on a scale of 1 to 10, with 10 being better rating) their satisfaction with the eye drop:
- 33% rated score of 10
- 91% rated score of 5+
What did the study authors conclude?
The authors reported that VEVYE was deemed to be “safe and well-tolerated during long-term use,” with the data demonstrating its ability to sustain 1 year of efficacy in both signs and symptoms of DED.
And lastly?
Harrow Chairman and CEO Marc L. Baum concluded that, with VEVYE’s individual BID dosing that’s only 1/10 the size of conventional eye drops, the “OLE data supports our efforts to make sure eyecare professionals and their patients are aware of how VEVYE helps managing (DED) by improving—over the longer term—the signs and symptoms of this chronic disease.”