27 October 2020 - - The US Food and Drug Administration has approved Eysuvis (loteprednol etabonate ophthalmic suspension) 0.25% for the short-term (up to two weeks) treatment of the signs and symptoms of dry eye disease, US-based biopharmaceutical company Kala Pharmaceuticals, Inc. (NASDAQ: KALA) said.

Dry eye disease is a chronic, episodic, multifactorial disease affecting the tears and ocular surface, and can involve tear film instability, inflammation, discomfort, visual disturbance and ocular surface damage.

Approximately 80% of people living with dry eye disease suffer from episodic flares.

These flares can be caused by a wide variety of triggers and often cannot be adequately managed with current therapies.

Eysuvis utilizes Kala's AMPPLIFY mucus-penetrating particle Drug Delivery Technology to enhance penetration of loteprednol etabonate into target tissue on the ocular surface.

LE targets the immune responses that drive acute dry eye disease flares.

Prior to Eysuvis, there were no FDA-approved ocular corticosteroids for the treatment of dry eye disease. Kala Pharmaceuticals plans to launch Eysuvis in the US by year-end.

The FDA granted approval to Eysuvis based on results from four clinical trials, including three Phase 3 trials and one Phase 2 trial, that demonstrated significant improvements in both the signs and symptoms of dry eye disease.

Specifically, statistical significance was achieved after two weeks of dosing for the sign endpoint of conjunctival hyperemia in all three Phase 3 trials.

Statistical significance was observed in two of the three Phase 3 trials for the symptom endpoints of ocular discomfort severity in both the overall intent-to-treat population and in a predefined subgroup of ITT patients with more severe ocular discomfort at baseline.

Eysuvis was well-tolerated across the four trials, with adverse events and intraocular pressure increases comparable to that observed with vehicle.

As of September 30, 2020, Kala had cash, cash equivalents and short-term investments of USD 159.1m.

Kala anticipates that its existing cash, cash equivalents and short-term investments, along with sales of INVELTYS, will enable it to fund its operations into at least 3Q22, with additional cash runway expected based on revenues from sales of Eysuvis.

Eysuvis, as with other ophthalmic corticosteroids, is contraindicated in most viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures.

The initial prescription and each renewal of the medication order should be made by a physician only after examination of the patient with the aid of magnification, such as slit lamp biomicroscopy, and, where appropriate, fluorescein staining.

Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, as well as defects in visual acuity and fields of vision.

Corticosteroids should be used with caution in the presence of glaucoma. Renewal of the medication order should be made by a physician only after examination of the patient and evaluation of the IOP.

Use of corticosteroids may result in posterior subcapsular cataract formation.

Use of corticosteroids may suppress the host response and thus increase the hazard of secondary ocular infections. In acute purulent conditions, corticosteroids may mask infection or enhance existing infection.

Use of a corticosteroid medication in the treatment of patients with a history of herpes simplex requires great caution. Use of ocular corticosteroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex).

Fungal infections of the cornea are particularly prone to develop coincidentally with long-term local corticosteroid application.

Fungus invasion must be considered in any persistent corneal ulceration where a corticosteroid has been used or is in use.

The most common adverse drug reaction following the use of EYSUVIS for two weeks was instillation site pain, which was reported in 5% of patients.

Eysuvis (loteprednol etabonate ophthalmic suspension) 0.25% is approved for the short-term (up to two weeks) treatment of the signs and symptoms of dry eye disease. Eysuvis utilizes Kala's AMPPLIFY mucus-penetrating particle Drug Delivery Technology to enhance penetration of loteprednol etabonate into target tissue of the ocular surface.

Eysuvis was approved by the FDA on October 26, 2020. Kala believes that Eysuvis' broad mechanism of action, rapid onset of relief of both signs and symptoms, favorable tolerability and safety profile and the potential to be complementary to existing therapies, offer a differentiated product profile for the management of dry eye flares.

Kala is a biopharmaceutical company focused on the discovery, development, and commercialization of innovative therapies for diseases of the eye.

Kala has applied its AMPPLIFY mucus penetrating particle Drug Delivery Technology to a corticosteroid, loteprednol etabonate, designed for ocular applications, resulting in the January 2019 launch of INVELTYS (loteprednol etabonate ophthalmic suspension) 1% and the October 2020 approval of Eysuvis (loteprednol etabonate ophthalmic suspension) 0.25% for the short-term (up to two weeks) treatment of signs and symptoms of dry eye disease.