Inveltys Eye drops
Inveltys (KPI-121 1%) eye drops are formulated for the treatment of pain and inflammation in patients who underwent eye surgery. Pain and inflammation are one of the most common complications expected after cataract surgery.
This is why a set of medications are prescribed to the patients after ocular surgery. One of these medications is corticosteroid eye drops which is usually prescribed at least four times a day.
One of the struggles and problems with treatment is Medication adherence and compliance. Having three to four different types of eye drops to be used in a day can be challenging. Imagine an elderly patient who had a cataract surgery and who has to use at least 3 different eye drops for two to four times a day. That could be a problem and can cause non-compliance.
Inveltys (KPI-121 1%) is a topical ocular corticosteroid that is designed to be used twice a day. Inveltys uses Kala Pharmaceuticals proprietary MPP technology (Mucus Penetrating Particle technology) that enhances drug delivery into the eye tissues. The MPP technology enhances drug delivery by three-fold by increasing penetration through the tear film.
Therefore, Inveltys not only enhances corticosteroid penetration into the eye tissues but also provides a dosing regimen that is easier for patients to follow.
Kala Pharmaceuticals is developing nanoparticle-based treatments through its proprietary MPP (mucus-penetrating particle) technology. The company aims to enhance drug delivery to the target tissues using the MPP technology.
The MPP technology has been used to create nanosuspensions of loteprednol etabonate, a corticosteroid for topical eye use. As a result, 2 products were developed: KPI-121 1% for the treatment of pain and inflammation post eye surgery and KPI-121 0.25% for the treatment of dry eye disease.
United States Food and Drug Administration (FDA)
On Oct 25, 2017, Kala Pharmaceuticals announced its submission of a New Drug Application (NDA) to the U.S. FDA for Inveltys, a twice-a-day topical corticosteroid for the treatment of pain and inflammation in post ocular surgery patients.
Two phases 3 clinical trials were completed to prove its safety and efficacy. The first clinical trial evaluates the use of Inveltys two times a day and KPI-121 0.25% four times a day for 14 days after cataract surgery.
Results shown that with both Inveltys and KPI-121 0.25%, both pain and inflammation were resolved by day 8 and maintained until day 15 without the need for rescue medications compared to a placebo.
A second confirmatory clinical trial was done to compare Inveltys to a placebo. Inveltys was used two times a day for two weeks and both inflammation and pain were resolved at day 8 and maintained until day 15 without the need for rescue medications.
There were no serious adverse reactions noted during the two clinical trials. There was also no significant increase in the eye pressure compared to placebo during treatment.
On January 5, 2018, the FDA accepted Kala Pharmaceuticals submission for Inveltys with an assigned target action date of August 24, 2018. If approved, Inveltys would be the first ocular corticosteroid to be approved by FDA for the treatment of pain and inflammation in patients who underwent ocular surgery with a twice-a-day dosing regimen.