Are there any new eye drops for dry eye?
In a word, YES: The pipeline is robust and we have a few new options recently USFDA approved and likely soon available. My “take” on them, based on their published studies and some discussions with colleagues involved in some of the studies (as well as some with a few years experience with Miebo, abroad).
Perflorohexyloctane (Miebo): Novaliq introduced this as EyeSol, then marketed it in Europe as EvoTears or Hycosan Shield, and now in the USA as Miebo by B&L,. It is 100% water-free , preservative free oil, dispensed as an “ARTIFICIAL TEAR” that may take the place of the normal human oil to help seal in the moisture when normal oil is missing. It has been used as a carrier for Cyclosporine (see the piece on Vevye, below, where they refer to Miebo as an “excipient” – in this case, meaning carrier), so could become useful in adding a measure of better tolerance to the stinging many patients complain about with the standard forms of Cyclosporine already available and appears to have a faster onset of action, though I don't know of any head-to-head studies between Vevye and Restasis, Cequa or the other cyclosporine eye drops already available. (chemically F6H8, Miebo is in the family of semifluorinated alkanes. I think of Miebo as “Tear Teflon,” as Teflon is in the family of Per- and polyfluoroalkyl substances).
My concerns about this product include the following: (1) the studies that got Miebo approved only compared it to dilute salty water (a pretty low bar), so how it will compare to other artificial tears already out there is a matter of debate. (2) Like any other preservative free artificial tear, I worry that if it "works," it is at best a better "Band-Aid" - in that it may allow patients yet another opportunity to treat symptoms (and feel better) without addressing the issues causing the symptoms (the underlying disease). This may "kick the can down the road" enough that the disease can progress to a point where it becomes ultimately harder to ever fix - and I can't see an inert chemical truly doing all the good things a normal, healthy, human tear would do for the surface of the eye.
That. being said, I've heard rumors and innuendos that it may "dissolve" some of the waxy oils clogging the oil glands. If so, I may have to retract this concern, as that could help "fix" the MGD problem - but until I see good clinical evidence of this, I remain a skeptic. (3) Not being a chemist, I may be off base, but this chemical seems a bit close to the "forever chemicals" (like Teflon derivatives) that I've tried to avoid in my lifetime. Things that are not intrinsic to human biology, nor easily broken down and digested, seem to have a habit of doing bad things. I understand that this has been used for years abroad and passed strict clinical trial evaluating safety, so I hope these fears remain unfounded. I should add that while sold in Europe for years, it has not been what most of my European colleagues would call a “game changer” for their dry eye patients. So far, it appears to be yet another artificial tear product that helps some more than others in fending off dry eye symptoms – so my expectations remain rather low (Vevye may be a different matter if it truly proves a better way for delivering cyclosporin - a medication I’ve come to know and respect – I’ll keep you posted).
Reproxalap: developed by Aldeyra (a so-called RASP inhibitor, referring to its mechanism of inhibiting a common part of the inflammation pathway leading to allergic responses and inflammatory reactions that can lead to dry eye disease) - I think of it a bit like a steroid without the side effects of stirring up eye pressure (IOP) that could lead to - or aggravate glaucoma, nor the side effect of aggravating or causing cataracts. This by itself is a major advancement in the field of anti-inflammation and may add a new chapter to what we can offer to fight inflammations causing redness, aqueous tear deficiency (what otherwise is treated with Cyclosporine or Lifitegrast, unless a steroid is used) and the many nuanced inflammations relating to allergies, friction, evaporation, etc. The place it will not likely be helpful is when fighting germs. Since it can be tough to determine when redness relates to an infection (or germ-related problems like blepharitis), versus the many other dry eye and allergy related issues causing redness, we may still need to be cautious about indiscriminate use - and like all new medications, it may take us a while to determine the best uses for this new class of drug.
To stay fair to the industry developing this new form of cyclosporine - I’ve copied verbatim, an introductory report directed to eye doctors (still pretty readable for the non-physicians who like to read frontline information)…
Taken from: Glance by Eyes On Eyecare <glance@eyesoneyecare.com>
“Are there any new eye drops for dry eye?
Yes! Novaliq GmbH has received FDA approval for VEVYE (cyclosporine ophthalmic solution) 0.1%, indicated for the treatment of the signs and symptoms of dry eye disease (DED).
Tell me more about VEVYE.
Developed under the name CyclASol, VEVYE is a cyclosporine formulation solubilized in a novel, water-free excipient—with no antimicrobial preservatives, oils, or surfactants.
Talk about this water-free component.
VEVYE is formulated with EyeSol, Novaliq’s proprietary, preservative- and water-free technology that uses ultrapure semifluorinated alkanes (SFAs).
According to the company, these SFAs have very low surface tension and viscosity, dispense low-volume drops (<12 µL) that do not stimulate blinking or reflex tearing, and have the same refractive index as water.
And this helps because…
By having low surface and interface tension, the drops are able to spread rapidly over the ocular surface and form a flat, transparent layer that could allow for improved visual clarity—without potential blurring.
What’s the dosing?
Per its prescribing information, one drop of VEVYE can be instilled twice a day (BID) in each eye, approximately 12 hours apart. See here for the full details.
What makes this unique?
After drops are administered, VEVYE can exhibit an increased residual time on the ocular surface and allow for a high bio-availability within the target tissues to release the solution’s fast onset of action within 2 weeks.
Any clinical trial info?
Yes! The randomized, multicenter phase 2/3 ESSENCE-1 trial and phase 3 ESSENCE-2 trial both concluded that the use of VEVYE (then CyclASol) led to clinically meaningful early therapeutic effects on the ocular surface when compared to vehicle. And the multicenter 12-month safety extension trial (ESSENCE-2 OLE) confirmed the effects of CyclASol were maintained and, in some cases, even improved for most sign and symptom endpoints.
Significance?
With this approval, VEVYE is now the first and only cyclosporine solution indicated for the treatment of signs and symptoms of DED, with an efficacy demonstrated over 4 weeks.
What else to know?
This latest approval marks the second for Novaliq is less than a month: the company, in partnership with Bausch + Lomb, received FDA approval in May 2023 for MIEBO (perfluorohexyloctane ophthalmic solution) for the treatment of signs and symptoms associated with DED. Click here for the details.”
Stay tuned!