Loteprednol etabonate is a Small Molecule owned by Kala Pharmaceuticals, and is involved in 9 clinical trials, of which 8 were completed, and 1 is ongoing.

Loteprednol etabonate works by enhancing the activity of glucocorticoid receptor. Activation of glucocorticoid receptor induces synthesis of anti-inflammatory protein through repression of pro inflammatory transcription factors. Glucocorticoid receptor is also found to have inhibitory effect on prostaglandin synthesis. The drug candidate by enhancing the activity of glucocorticoid receptor may reduce the inflammation and pain associated with the disease.

The revenue for Loteprednol etabonate is expected to reach a total of $1.4bn through 2038. This change impacts the valuation of this asset and is an important factor to understand the current value of the drug in a clinical process. View the complete picture with the Loteprednol etabonate NPV Report.

Loteprednol etabonate is currently owned by Kala Pharmaceuticals.

Loteprednol etabonate Overview

Loteprednol ebonate (Inveltys, Eysuvis) is a androgen derivative, acts as an anti-inflammatory and an anti-allergic agent. It is formulated as drops – suspension for ophthalmic route of administration. Inveltys is indicated for the treatment of post-operative inflammation and pain following ocular surgery.

Loteprednol etabonate (LE-MPP, KP-121) is under development for the treatment of dry eye disease. It is administered as ophthalmic drops. It acts by targeting glucocorticoid receptor 2. It is developed based on mucus-penetrating particle (MPP) platform consist of selectively-sized nanoparticles and have proprietary coatings. It was also under development for retinal vein occlusion (RVO), diabetic macular edema (DME) and meibomian gland disease (MGD).

Kala Pharmaceuticals Overview

Kala Pharmaceuticals is a clinical stage pharmaceutical company. It offers nanoparticle-based treatments for ocular diseases affecting both front and back of the eye. The company’s AMPPLIFY technology, treats the medical needs for the front of the eye, and NCEs, targeted to address front and back of the eye diseases. Its pipeline products includes EYSUVIS (loteprednol etabonate ophthalmic suspension), is used for the treatment of short-term (up to two weeks) treatment of the signs and symptoms of dry eye disease, and INVELTYS (loteprednol etabonate ophthalmic suspension), a topical twice-a-day ocular steroid for the treatment of post-operative inflammation and pain following ocular surgery. It supplies its products across the US and Europe. Kala Pharmaceuticals is headquartered in Watertown, Massachusetts, the US.

The company reported revenues of (US Dollars) US$11.2 million for the fiscal year ended December 2021 (FY2021), an increase of 76.7% over FY2020. The operating loss of the company was US$134.3 million in FY2021, compared to an operating loss of US$96.2 million in FY2020. The net loss of the company was US$142.6 million in FY2021, compared to a net loss of US$104.3 million in FY2020. The company reported revenues of US$0.4 million for the third quarter ended September 2022, a decrease of 80% over the previous quarter.

Quick View – Loteprednol etabonate

Report Segments
  • Innovator (Non-NME)
Drug Name
  • Loteprednol etabonate
Administration Pathway
  • Ophthalmic
Therapeutic Areas
  • Central Nervous System
  • Metabolic Disorders
  • Ophthalmology
Key Companies
Highest Development Stage
  • Marketed

GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

To create this model, GlobalData takes into account factors including patent law, known and projected regulatory approval processes, cash flows, potential applicable patients, drug margins, company expenses, and pricing estimates. Combining these data points with GlobalData’s world class analysis creates high value models that companies can use to help in evaluation processes for each drug or company.

The rNPV method integrates the probability of a drug reaching a clinical stage into the cash flow at that time, which provides a more accurate rNPV, as it considers the probability that the drug never makes it through the clinical pathway to commercialization. GlobalData’s rNPV model uses proprietary likelihood of approval (LoA)and phase transition success rate(PTSR) data for the indication in the highest development stage, which can be found on GlobalData’s Pharmaceutical Intelligence Center.