Kala Pharmaceuticals Announces IND Submission of its MPP-Formulated Loteprednol Etonbonate (LE-MPP) for Post-Cataract Surgery

Kala Pharmaceuticals Announces IND Submission of its MPP-Formulated Loteprednol Etonbonate (LE-MPP) for Post-Cataract Surgery

Waltham, Mass., January 6, 2014 – Kala Pharmaceuticals, Inc., a leading developer of innovative ophthalmic products based on the Company's proprietary Mucus Penetrating Particle (MPP) technology, announced today that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration to initiate a Phase 3 clinical program with its MPP-formulated loteprednol etabonate ophthalmic nano-suspension product (LE-MPP) for the treatment of post-operative inflammation and pain following cataract surgery.

Kala's proprietary MPP technology platform allows therapeutic agents to pass through the mucus layer of the ocular surface, facilitating penetration into deeper tissues of the eye, including the aqueous humor and retina.  Kala's MPPs are designed to potentiate pharmacological effects within target tissues.  The objective of the upcoming clinical trial with Kala's LE-MPP product is to demonstrate anti-inflammatory efficacy similar to that of other steroid-based treatments with less frequent (twice-daily) dosing while maintaining the safety profile of current loteprednol etabonate products. 

"It's exciting to see nanoparticle technology moving to the forefront of the ophthalmology field.  By combining small particle size and state-of-the-art surface engineering techniques, physicians and patients should benefit from a variety of new and improved therapeutic options across ophthalmic disease states," said Terry Kim, MD, Professor of Ophthalmology at Duke University Eye Center.

"In preclinical studies, LE-MPP demonstrated a superior pharmacokinetics profile in target tissues compared to currently marketed loteprednol etabonate products" said Kim Brazzell, Ph.D., Kala's Chief Medical Officer.  "In head-to-head preclinical studies, LE-MPP delivered significantly greater levels of drug to the aqueous humor, as well as the cornea, conjunctiva, and retina than either Lotemax® Suspension or Lotemax® Gel with similar dosing regimens.  The objective of the upcoming clinical trial will be to demonstrate if twice-daily administration of 1% LE-MPP is effective in the treatment of inflammation and pain following cataract surgery.  If successful, this would represent a significant dosing advantage compared to other topical steroids, which are currently indicated for four times a day dosing."

"The global topical corticosteroid market is significant and growing based on the aging population.  A topical corticosteroid with superior penetration and pharmacokinetics and a more favorable dosing regimen would be a welcome alternative to current treatment regimens," said Guillaume Pfefer, Ph.D., Kala's President and Chief Executive Officer.  "Beyond the post-surgical program, Kala plans to initiate clinical programs with lower doses of LE-MPP in both dry eye disease and blepharitis in 2014."

About Kala Pharmaceuticals

Kala Pharmaceuticals, Inc. is advancing innovative treatments for ocular diseases addressing significant unmet needs in both front and back of the eye based on the Company's proprietary Mucus Penetrating Particle (MPP) technology.  Kala's topical ocular MPP formulations enhance penetration of diverse therapeutic agents into ocular tissue, including those in the back of the eye, by facilitating penetration through the mucus layer of tear film.  Kala's product development pipeline includes: a 1% formulation of loteprednol etabonate (1% LE-MPP) to treat post-surgical ocular inflammation and pain, expected to enter a pivotal clinical study in 2014; a 0.25% LE-MPP formulation for dry eye, blepharitis, and retinal disease, expected to enter clinical trials in 2014, and a topically applied receptor tyrosine kinase inhibitor (RTKi-MPP) for the treatment of wet age-related macular degeneration (AMD), which is advancing toward selection of a clinical candidate in 2014.

Kala's approach to penetrating mucus layers also has potential application in other disease areas, such as respiratory, female reproductive tract, and gastrointestinal diseases, and in these areas the Company will seek partners to out-license its breakthrough technology.  Kala was founded by leaders in the fields of nanomedicine and biopharmaceutical engineering, maintains an esteemed group of advisors including co-founder and MIT professor Dr. Robert Langer, and is backed by leading investors including Lux Capital, Polaris Venture Partners, Third Rock Ventures, and Crown Venture Fund, LLC.  For more information, please visit www.kalarx.com.

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Kala Pharmaceuticals Appoints Howard B. Rosen as Chairman of the Board of Directors

Industry leader brings corporate strategy, operations expertise

Waltham, Mass., January 6, 2014 – Kala Pharmaceuticals, Inc., a leading developer of innovative products that enhance penetration of therapeutic agents into ocular tissue based on the Company's proprietary Mucus Penetrating Particle (MPP) technology, today announced the appointment of Howard B. Rosen as Chairman of the company's board of directors.

"Howard's extensive track record of building and guiding successful companies will be extremely helpful to Kala at this critical juncture as we advance a rich pipeline of ophthalmology product candidates into clinical development," said Guillaume Pfefer, Ph.D., Kala's President and Chief Executive Officer.  "Howard is an experienced visionary and is ideally suited to provide leadership guidance for Kala to evolve to the next level with broad applications for our MPP technology, not only in ocular diseases but also other potential indications involving mucus tissues including respiratory and gastrointestinal disease."

Commenting on his appointment to the Kala board, Mr. Rosen said, "Upon first introduction to Kala, I was immediately impressed by the many attributes of Kala's MPP technology which open up a breadth of opportunities across a wide range of diseases. I look forward to leveraging my experience to guide Kala as it continues to grow and evolve."

Mr. Rosen brings more than twenty-five years of experience serving in management and board positions in the biotechnology industry. He currently serves on the board of directors of AcelRx Pharmaceuticals, Inc. (NASDAQ: ACRX), ALCOBRA, LTD (NASDAQ: ADHD), ALDEA Pharmaceuticals, Inc., Entrega, Inc., and PaxVax, Inc, where he has served as Chairman since 2011.  From 2010 to 2011, he served as interim President and Chief Executive Officer of Pearl Therapeutics, which was acquired by AstraZeneca in June 2013. From 2004 to 2008, he was Vice President, Commercial Strategy at Gilead Sciences, Inc.  Prior to joining Gilead, Mr. Rosen was President of ALZA Corporation where he was responsible for all aspects of managing ALZA as an independent 1000-person operating company within the Johnson & Johnson family of companies.  Over his ten years at ALZA, Mr. Rosen had responsibilities for product development, portfolio management, corporate and new product planning, mergers and acquisitions, R&D planning, and technology ventures. Prior to joining ALZA, Mr. Rosen managed the west coast practice of Integral, Inc., was Director of Corporate Development at GenPharm International, Inc. and was a consultant in the San Francisco office of McKinsey & Co. Mr. Rosen is a member of the Biomedical Engineering Advisory Board at City College of New York and the board of directors of the MIT Club of Northern California.  Mr. Rosen is a Lecturer in the Department of Chemical Engineering at Stanford University and a Lecturer in Management at the Stanford Graduate School of Business.  He is also a member of the National Academy of Engineering, where he is Chair of the Bioengineering Section.  Mr. Rosen holds a B.S. in Chemical Engineering from Stanford University, an M.S. in Chemical Engineering from the Massachusetts Institute of Technology and an M.B.A. from the Stanford Graduate School of Business.

About Kala Pharmaceuticals

Kala Pharmaceuticals, Inc. is advancing innovative treatments for ocular diseases addressing significant unmet needs in both front and back of the eye based on the Company's proprietary Mucus Penetrating Particle (MPP) technology.  Kala's topical ocular MPP formulations enhance penetration of diverse therapeutic agents into ocular tissue, including those in the back of the eye, by facilitating penetration through the mucus layer of tear film.  Kala's product development pipeline includes: a 1% formulation of loteprednol etabonate (1% LE-MPP) to treat post-surgical ocular inflammation and pain, expected to enter a pivotal clinical study in 2014; a 0.25% LE-MPP formulation for dry eye, blepharitis, and retinal disease, expected to enter clinical trials in 2014, and a topically applied receptor tyrosine kinase inhibitor (RTKi-MPP) for the treatment of wet age-related macular degeneration (AMD), which is advancing toward selection of a clinical candidate in 2014.

Kala's approach to penetrating mucus layers also has potential application in other disease areas, such as respiratory, female reproductive tract, and gastrointestinal diseases, and in these areas the Company will seek partners to out-license its breakthrough technology.  Kala was founded by leaders in the fields of nanomedicine and biopharmaceutical engineering, maintains an esteemed group of advisors including co-founder and MIT professor Dr. Robert Langer, and is backed by leading investors including Lux Capital, Polaris Venture Partners, Third Rock Ventures, and Crown Venture Fund, LLC.  For more information, please visit www.kalarx.com.

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