The following abstract is a medical study using a new type of eye drop for dry eye. I can already hear you that you have used every drop under the sun, but believe me this is new! Dry Eyes we know have significant inflammation that occur in conjunction with the condition. This particular drug currently just termed SAR 1118 is based around a class of anti-inflammatory drug that has had some success in treatment of asthma. Other anti-inflammatories that are currently used successfully are steroidals and Restasis (cyclosporine).
Stay tuned for more updates.
“The goal of this study was to investigate the efficacy and safety of an investigational integrin antagonist (SAR 1118) ophthalmic solution compared to placebo (vehicle) in subjects with dry eye disease.
This was a multicenter, prospective, double-masked, placebo-controlled trial. A total of 230 dry eye subjects selected with use of a controlled adverse environment were randomized 1:1:1:1 to receive SAR 1118 (0.1%, 1.0%, 5.0%) or placebo eye drops twice daily for 84 days. Principal eligibility criteria included exacerbation in corneal staining and ocular symptoms with controlled adverse environment exposure, no active lid margin disease, and Schirmer test (mm/5 min) >1 and <10. Ocular signs and symptoms (Ocular Surface Disease Index, OSDI) were assessed at day 14, 42, and 84. No supplemental artificial tears were allowed. Primary outcome measure was inferior corneal staining score at day 84.
A dose response for the corneal staining score (P = .0566) was observed for SAR 1118 at day 84 compared to placebo. Mean change from baseline to day 84 showed significant improvements (P < .05) in corneal staining score, total OSDI, and visual-related function OSDI scores for SAR 1118 compared to placebo; improvements in tear production and symptoms were observed as early as day 14 (P < .05). Adverse events were mild and transient in nature with no serious ocular adverse events. SAR 1118 5.0% showed increased instillation site adverse events relative to placebo but were limited to the initial dose.
The researchers concluded that SAR 1118 demonstrated improvements in signs and symptoms of dry eye compared to placebo and appears safe when administered over 84 days.
Semba CP, Torkildsen GL, Lonsdale JD, et al. A Phase 2 Randomized, Double-Masked, Placebo-Controlled Study of a Novel Integrin Antagonist (SAR 1118) for the Treatment of Dry Eye. Am J Ophthalmol. 2012 Feb 11.”
Restasis certainly has a place in dry eye management but the problem is that the original studies showed only very marginal benefit when compared to the vehicle (ie the lubricant that the cyclosporine was dissolved in). I have to admit that I have been disillusioned with all the paper work that the TGA has put practitioners through. It is always worth a trial but this is blocked purposely by the bureacracy.
I have even compounded unpreserved cyclosporine but I have to say that the response is hit and miss at best.
It is a very frustrating world that we live in and I am not sure what to do. Maybe things will change but I doubt it as meibomian gland dysfunction is more prevalent that aqueous dysfunction (which Restasis is better for).