Alcon to Acquire Eysuvis and Inveltys from Kala Pharmaceuticals

Alcon will significantly bolster its pharmaceutical offerings after reaching an agreement to acquire Kala Pharmaceuticals' commercial portfolio, which includes dry eye drug Eysuvis (loteprednol etabonate suspension 0.25%), and Inveltys (loteprednol etabonate suspension 1%) for the treatment of postoperative inflammation and pain following ocular surgery.

Under terms of the agreement, Alcon will pay $60 million upfront, plus potential milestone payments. The transaction is anticipated to close in third quarter of 2022, subject to customary closing conditions, including regulatory approval. Revenues for Eysuvis and Inveltys for full-year 2021 were $6.3 million and $4.9 million, respectively. Alcon’s full year 2022 guidance is unchanged as a result of the transaction.

Alcon said Eysuvis will complement the Systane family of eye drops which includes the recently launched Systane preservative-free formulations now available in a multi-dose bottle. While the Systane family is used for ongoing management of dry eye symptoms, Eysuvis will provide eye care professionals (ECPs) with an option for short-term treatment to mitigate dry eye disease.

Eysuvis was approved by the FDA in January 2021 as the first-and-only corticosteroid indicated for up to 2 weeks of treatment of the signs and symptoms of dry eye disease. The prescription therapy utilizes a proprietary drug delivery technology known as Ampplify to enhance penetration of loteprednol etabonate into targeted tissue on the ocular surface, helping to prevent flares associated with dry eye disease.

“We will be pleased to add Eysuvis to our growing pharmaceutical portfolio,” said Sergio Duplan, President, North America at Alcon. “Eysuvis is a natural fit for our newly formed ophthalmic eye drop sales force in the United States. With our strong expertise in market access and commercial execution, we are well-positioned to build the market for acute dry eye treatment.”

As part of the agreement, Alcon will also acquire Inveltys, the only corticosteroid for twice-a-day treatment of postoperative inflammation and pain following ocular surgery.

“The sale of Eysuvis and Inveltys is an important step as we execute on our strategic plan and pursue our mission of delivering innovative therapies that can address significant unmet needs in ophthalmology,” Mark Iwicki, Chief Executive Officer and Chairman of Kala, said in a company news release. 

“Alcon is an ideal partner to expand the reach of our commercial assets. Alcon has a decades-long history of delivering market-leading vision care to patients around the world and benefits from robust franchises in dry eye disease and surgical care, making them deeply familiar with eye care professionals and the patients Eysuvis and Inveltys are intended to treat. We look forward to working with Alcon through this transition and, ultimately, to devoting our internal resources to developing innovative therapies, including KPI-012, to further transform the treatment of eye diseases,” he added.

Kala plans to focus on developing KPI-012, a novel cell-free secretome therapy that has the potential to address a number of rare and severe ocular diseases.

Subject to the submission and clearance of an investigational new drug application for KPI-012, Kala expects to initiate a phase 2/3 clinical trial of KPI-012 for persistent corneal epithelial defect (PCED) in the fourth quarter of 2022 and plans to expand its development program for KPI-012 into additional front and back of the eye indications, with additional details forthcoming in the months ahead.

Following the closing of the sale of its commercial assets, Kala expects to realize a substantial reduction in operating expenses, which together with the net proceeds from the upfront cash payment received from this transaction, will extend Kala’s operating cash runway into the second quarter of 2024, beyond the expected KPI-012 phase 2/3 data readout.