Tivanisiran (SYL1001) is a new dry eye medication currently undergoing clinical trials. From Sylentis, a Biotech company founded in 2006, this medication is intended to relieve ocular discomfort and improve other signs of dry eye disease.
In January 2019, results of the Phase 3 HELIX efficacy and safety trial with tivanisiran were released. In this study involving 330 patients, the medication was shown to improve central corneal staining in patients with moderate to severe dry eye disease. These results were noted after one month of treatment with tivanisiran. However, the medication was not able to demonstrate any clinically significant difference over placebo for the endpoint of ocular pain, which means that this medication will need to undergo further testing before being approved by the FDA. Additional endpoints that were improved with this medication include an increase in mucin and a decrease in the inflammatory marker, HLA-DR.
Administered as eye drops, this medication selectively inhibits the production of transient receptor potential cation channels, which have the potential to mediate the transmission of ocular pain (something that many dry eye patients know well). While this medication still has a long way to go in the FDA pipeline, it would hopefully help dry eye patients find relief from pain as well as an improvement in their signs and symptoms of dryness.
About the Company
As stated earlier, Sylentis is a relatively new biotech company started in Spain in 2006. Their mission is to become the leader in developing new medications based on RNA interference, or RNAi. The nobel prize in medicine was awarded to those who discovered interference RNA in 2006, and this new genre of medicine would be quite different from those that currently tackle the inflammatory component of dry eye. This represents a new mechanism of action for medications and the hope is that this interference will silence the target genes involved in many diseases, including dry eyes. So far, Sylentis is concentrating their market research on industries which include ocular pathology, central nervous system disorders and diseases, and inflammatory conditions.
At this time, there are no coupons for this new Sylentis medication because it is still going through clinical trials and is not available to the public yet. Once it is, we will update you on any coupons or savings available.
Sylentis Side Effects
During the clinical trials so far, no significant side effects were attributed to the use of the Sylentis eye drops over the treatment period. While this is a great thing, we doubt that the medication will have zero side effects. For example, all eye drops will sting or burn if the eyes are inflamed enough, so we can expect that these eye drops will also burn for those people who have really inflamed eyes (and that is what this medication is intended to help). This side effect is always temporary and will subside and lessen as the eyes heal.
Another common side effect with all eye drops is blurred vision. Blurry vision after eye drop use is so common because when you instill eye drops, you’re creating another layer of tears on top of the cornea and layer of tears that you already have. This is going to be another layer to look through, and can therefore make your eyes blurry for a few minutes. For a medication such as this, we can expect the blurriness to last up to five minutes but no longer.
In addition to these, it is also common to notice a strange taste in the back of the throat after using eye drops (this is especially true of corticosteroid and allergy eye drops). Although we do not know what the taste of this medication will be, it is common to “taste” eye drops after use because the eyes are interconnected with the sinuses and throat. This side effect will also subside quickly and, if it really bothers you, make sure to drink a big glass of water or green smoothie right after using your drops.
While we have no information on the pricing of this medication yet, we do have experience with previous new medications that have been released. For example, purchasing Restasis at the cash price (without insurance) will cost a bit more than $500/month, and this medication is over 15 years old. Xiidra will also run you a bit over $500 for a one month supply, so we can only guess that this new medication from Sylentis will be similar. However, insurance will often pick up a large chunk of this cost for many, and it’s likely that Kala will have coupons or savings for the patient once the medication is released.
Sylentis Generic and Alternatives
Restasis, Xiidra, and Cequa are currently the only other prescription medications that have been FDA approved for the treatment of dry eye disease. Restasis (cyclosporine ophthalmic emulsion 0.05%) is a prescription medication FDA approved in late 2002 to help treat dry eyes by making more of your own tears. Cyclosporine is a calcineurin inhibitor immunosuppressant, which helps strengthen your body's natural ability to produce the tears it should, which is often an issue when dealing with inflammation from chronic dry eye. Cequa (cyclosporine ophthalmic solution 0.09%), brand new in the US in 2019, is simply a higher dosage of cyclosporine using a different delivery vehicle.
Xiidra (lifitegrast ophthalmic solution 5%) became FDA approved in mid-July 2016 and is FDA approved to treat the signs and symptoms of dry eye disease, or keratoconjunctivitis sicca. We know that this is technical and a bit confusing, but it basically works by inhibiting the binding of inflammatory cells. This mechanism decreases inflammation mediated by white blood cells that play a critical role in your body’s immunity, therefore improving dry eye signs and symptoms.
All three of these medications are available through a prescription from your eye doctor’s office, and all of them will run you at least $500 per month without insurance. Unfortunately at this time, there are no generic versions of these medications available in the United States.
Are you excited to try a new dry eye medication? What others have you tried in the past? Let us know in the comments!
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