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Details:
The acquisition will complement Alcon’s existing portfolio in the large and fast-growing dry eye category. EYSUVIS (Loteprednol Etabonate) will complement the Systane® family of eye drops which includes the recently launched Systane Preservative-Free formulations.
Lead Product(s): Loteprednol Etabonate
Therapeutic Area: Ophthalmology Product Name: Eysuvis
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Alcon Inc
Deal Size: Undisclosed Upfront Cash: $60.0 million
Deal Type: Acquisition May 23, 2022
Details:
Kala is marketing two approved ophthalmology products, EYSUVIS® for the short-term (up to two weeks) treatment of the signs and symptoms of dry eye disease (“DED”), and INVELTYS® for the treatment of post-operative inflammation and pain following ocular surgery.
Lead Product(s): Loteprednol Etabonate
Therapeutic Area: Ophthalmology Product Name: Eysuvis
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Oxford Finance
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Financing May 12, 2021
Details:
Loteprednol Etabonate Ophthalmic Gel, 0.5% is indicated for the treatment of post-operative inflammation and pain following ocular surgery.
Lead Product(s): Loteprednol Etabonate
Therapeutic Area: Ophthalmology Product Name: Undisclosed
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 11, 2021
Details:
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.
Lead Product(s): Loteprednol Etabonate
Therapeutic Area: Ophthalmology Product Name: Eysuvis
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 27, 2020
Details:
STRIDE 3 trial of EYSUVIS met both of its primary symptom endpoints, demonstrating a statistically significant improvement in ocular discomfort severity in both ITT population.
Lead Product(s): Loteprednol Etabonate
Therapeutic Area: Ophthalmology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 04, 2020
Details:
STRIDE 3 met both prespecified primary efficacy endpoints, ocular discomfort severity in the overall ITT population and in ITT patients with more severe baseline discomfort.
Lead Product(s): Loteprednol Etabonate
Therapeutic Area: Ophthalmology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 09, 2020
Details:
If approved, Kala plans to commercialize KPI-121 0.25% under the brand name EYSUVIS™.
Lead Product(s): Loteprednol Etabonate
Therapeutic Area: Ophthalmology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 15, 2020
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