New dry eye option nears regulatory resubmission in USA

9 March 2020

Shares in US drug developer Kala Pharmaceuticals (Nasdaq: KALA) leapt 10% at the opening bell in New York on Monday, when most shares were slumping due to coronvirus worries, after the firm announced positive top-line results from the Phase III STRIDE 3 study.

The eye specialist has been evaluating KPI-121 for the treatment of dry eye disease.

The trial met both of its primary efficacy endpoints, demonstrating a statistically-significant improvement in the symptom endpoint of ocular discomfort severity (ODS) after 15 days.

Kala plans to commercialize the drug under the brand name Eysuvis (loteprednol etabonate), and will submit the data to the US Food and Drug Administration in the second quarter of 2020.

This article is accessible to registered users, to continue reading please register for free. A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.

Try before you buy

Free

7 day trial access

Take a Free Trial

All the news that moves the needle in pharma and biotech
Exclusive features, podcasts, interviews, data analyses and commentary from our global network of life sciences reporters.
Receive The Pharma Letter daily news bulletin, free forever.

Become a subscriber

£820

Or £77 per month

Subscribe Now

Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
Daily roundup of key events in pharma and biotech.
Monthly in-depth briefings on Boardroom appointments and M&A news.
Choose from a cost-effective annual package or a flexible monthly subscription

The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed

Chairman, Sanofi Aventis UK