Guaynabo, Puerto Rico, October 28, 2021 — IACTA Pharmaceuticals, Inc. (“IACTA”), an innovation leader in ophthalmic therapeutics, today announced that the U.S. Army Medical Research Acquisition Activity (USAMRAA), a division of the Department of Defense, has granted a $1 million award to the company to fund preclinical studies of IC 800, a novel therapy for the topical treatment of ocular pain, utilizing the body’s endogenous pain controllers, the enkephalins. This award was supported by The Assistant Secretary of Defense for Health Affairs, through the Vision Research Program (VRP), Translational Research Award (TRA), under Award No. W81XWH-21-1-0584. The award will be used for the development of an eye drop formulation, supportive animal toxicology studies, and preparation and filing of an Investigation New Drug (IND) application with the FDA.

Eye injury occurs in approximately 15% of all battlefield trauma. A very significant and immediate result of eye trauma is acute pain, which frequently evolves into chronic pain. Non-steroidal anti-inflammatory drugs (NSAIDs) and steroids are two common treatments for ocular pain, but both have limitations in terms of both efficacy and side effects. IC 800 is a novel, non-opioid, dual enkephalinase inhibitor (DENKI), being developed as an efficacious topical ocular analgesic, packaged in a single-use, sterile, unit dose applicator, which can be easily administered in low resource environments.

IC 800 uses IACTA’s proprietary DENKI molecule to inhibit enzymes that degrade the body’s natural response to pain. DENKI increases the local concentrations of enkephalins, the opioid peptides produced by the body to relieve pain. Early preclinical ocular studies showed similar efficacy and the potential for improved safety when compared to the ocular use profile for opioids, such as morphine. IACTA’s development of DENKIs for ocular injury in a military setting is an integral part of IACTA’s strategic intent to develop DENKIs for acute and chronic ocular pain associated with LASIK®, cataract and photorefractive keratectomy (PRK) surgery, blunt force injury, and dry eye disease.

“I am delighted to have the support of the U.S. Department of Defense as IACTA advances IC 800 for the treatment of ocular pain. The U.S. military has an extensive history of research leading to medical advancements that translates to providing ongoing benefits to military and civilian patients,” said Damon Burrows, Chief Executive Officer of IACTA Pharmaceuticals. “The prevalence of ocular pain from battlefield trauma is high and it is alarming among our veterans with more than 15,000 veterans filing new ocular disabilities each year¹. Our innovative dual enkephalinase inhibitor enhances the body’s natural pain management system, creating the potential for a safe, non-addictive pain management therapy. I look forward to our ongoing collaboration with the U.S. Department of Defense while developing a novel ocular pain treatment that may benefit both service members and civilians.”

About IACTA Pharmaceuticals, Inc.
IACTA is an innovation leader in ophthalmic therapeutics, led by former top executives from one of the leading eye care companies in the world. The company currently has four products in development for major market opportunities. IC 800 is a novel, non-opioid, dual enkephalinase inhibitor, being studied for the treatment of acute ocular pain. In addition, IACTA’s IC 265, is a SYK kinase inhibitor being developed as a potential novel treatment for dry eye disease. For more information, please visit www.iactapharma.com.

Forward-Looking Statements
Any statements in this press release that are not historical facts are forward-looking statements made under the provisions of the Private Securities Litigation Reform Act of 1995. Any forward-looking statements involve risks and uncertainties that could cause actual results to be materially different from historical results or any future results expressed or implied by such forward-looking statements. Such statements include the potential for IC 800 and IC 265. Any forward-looking statements in this press release represent the Company’s views only as of the date of this release and should not be relied upon as representing its views as of any subsequent date. The Company specifically disclaims any obligation to update this information as a result of future events or otherwise, except as required by applicable law.

Disclaimer
Opinions, interpretations, conclusions and recommendations are those of IACTA Pharmaceuticals and are not necessarily endorsed by the Department of Defense. In conducting research using animals, the investigator adheres to the laws of the United States.

IACTA is a registered trademark of Iacta Pharmaceuticals, Inc., and DENKI is a trademark licensed to Iacta Pharmaceuticals, Inc. All other trademarks are owned by their respective owners.

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