Further information with respect to the credit facility are set forth in the form 8-K filed by the company with the Securities and Exchange Commission on October 2, 2018.
Morgan Stanley and Co. LLC acted as sole structuring agent on the transaction.
Inveltys (loteprednol etabonate ophthalmic suspension) 1% is a twice-a-day corticosteroid for the treatment of inflammation and pain following ocular surgery.
Inveltys utilises Kala's proprietary Mucus-Penetrating Particle technology to enhance penetration into target tissues of the eye.
In preclinical studies, MPP technology increased delivery of loteprednol etabonate into ocular tissues compared to current LE products.
Inveltys was approved by the FDA on August 22, 2018. Kala believes Inveltys has a favourable profile for the treatment of inflammation and pain following ocular surgery, due to its twice-a-day dosing regimen.
Kala is developing KPI-121 0.25% for the temporary relief of the signs and symptoms of dry eye disease utilizing a two-week course of therapy administered four times a day.
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.
KPI-121 0.25% utilises Kala's MPP technology to enhance penetration of LE into target tissue of the eye.
Kala has completed one Phase 2 and two Phase 3 clinical trials of KPI-121 0.25%. Kala has initiated a third Phase 3 trial, STRIDE 3, for which topline results are expected in 4Q19.
Kala believes that, if approved, KPI-121 0.25%'s broad mechanism of anti-inflammatory activity, rapid onset of relief of both dry eye signs and symptoms, favourable tolerability and safety profile and the potential to complement existing therapies, could result in a favourable profile for the management of dry eye flares and other dry eye associated conditions where short-term treatment is beneficial.
Kala is a biopharmaceutical company focused on the development and commercialization of therapeutics using its proprietary Mucus Penetrating Particle technology, with an initial focus on the treatment of eye diseases.
Kala has applied the MPP technology to a corticosteroid, LE, designed for ocular applications, resulting in the recent approval of Inveltys for the treatment of inflammation and pain following ocular surgery.
Kala plans to submit a New Drug Application for KPI-121 0.25%, for the temporary relief of the signs and symptoms of dry eye disease in the second half of 2018.
Athyrium is a specialized asset management company formed in 2008 to focus on investment opportunities in the global healthcare sector. Athyrium advises funds with over USD 3.7bn in committed capital.
The Athyrium team has substantial investment experience across a wide range of asset classes including public equity, private equity, fixed income, royalties, and other structured securities.
Athyrium invests across all healthcare verticals including biopharma, medical devices and products, healthcare focused services, and healthcare information technology. The team partners with management teams to implement creative financing solutions to companies' capital needs.
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