Journal roundup: Therapeutics
There was a review published in January about this new cyclosporine drug that doesn’t seem to have hit the market yet (but should soon - it was FDA approved last summer). Just a couple of snippets from this review caught my eye. Now let’s see if they can deliver, in practice.
has the potential to deliver therapeutic concentrations of CsA with minimal discomfort to patients
That would be an extremely welcome change after 15 years of patients saying that Restasis burns.
[CEQUA] is highly effective, safe, and has a rapid onset of action in treating KCS
Again… if true, that’s a start contrast, at least the rapid onset part.
More: Ocular Pharmacokinetics of a Topical Ophthalmic Nanomicellar Solution of Cyclosporine (Cequa®) for Dry Eye Disease. (Mandal et al, Pharmaceutical Research, Jan 2019)
Sigh. I’ve been promising to write about this for ages because I know a lot of people are asking, and I still haven’t put together a page on it. Sorry! But here at least is a recent study.
What is TrueTear? It’s a medical device currently available on the US market. And yes, it’s the weird thing you stick up your nose to stimulate tears.
This study took place in Australia and New Zealand. First thing that caught my eye was “double-masked”. If you’re not familiar with clinical trial lingo, that means some people get the real thing, some people get a fake, and neither the participants nor the doctors know which. But, um, how on earth do you design a believable control for this? (How do you stick something up your nose without touching anything?) Interesting.
Mild nosebleed, the most common device-related AE, was reported in five (16.7%) subjects.
Intranasal neurostimulation was effective in inducing acute tear production after 90 days of use and generally was well tolerated in subjects with dry eye disease.
Can’t argue with that.
Actually, with this device, I’m rather more interested in the murmurings here and there about studying it for neuropathic corneal pain issues than for simple tear stimulation. Looking forward to seeing something get published about this eventually. In the meantime, I have to say the feedback is mixed but I know quite a few people who have had good enough results to continue using it. Definitely one of those things where you want to have a clear conversation about whether you’re an appropriate candidate and why. But then those are good conversations to have about every treatment.
More: Randomized, Controlled, Double-Masked, Multicenter, Pilot Study Evaluating Safety and Efficacy of Intranasal Neurostimulation for Dry Eye Disease. (Cohn et al, IOVS, January 2019)
Next up… this is a drug on our Dry Eye Pipeline listing. They announced results last October and details have now been published. CyclASol is a new cyclosporine drug in two strengths (0.1%, 0.05%).
CyclASol showed a consistent reduction in corneal and conjunctival staining compared to both vehicle and Restasis…
…In a direct head to head against open-label RestasisTM, CyclASol® was found to have an earlier onset of action, as early as after two weeks of treatment in relieving the signs of DED, as measured by corneal and conjunctival staining.
On the other hand:
This model-based analysis suggests a significant CyclASol effect for OSDI© as symptom parameter (p<0.01).
I have no idea what that means. Did they feel better or not? “Suggests” is not exactly confidence inspiring.
More: A Clinical Phase 2 Study to Assess Efficacy, Safety and Tolerability of CyclASol® for Treatment of Dry Eye Disease (DED). (Wirta et al, Ophthalmology, January 2019)
There are so many more studies on therapeutics that came out in the past month or so - I’m going to have to wait and cover them next week. There’s a couple about the new neurotrophic keratopathy drug, something about stem cells, something about serum for neuropathic corneal pain, amniotic membrane and more.