Studies to Evaluate Standardized, Novel, Enriched Biologicfor Ocular Graft-vs.-Host Disease and Moderate to Severe Dry Eye
ATLANTA, GA –July 6, 2021 – Cambium Medical Technologies (“Cambium”), a clinical stage company developing novel processed platelets for therapeutic applications, announced today notification from the FDA that the company can begin two Phase III studies on its Elate Ocular® biologic for dry eye.
As previously announced, Cambium completed a Phase I/II study in 2021 assessing safety and exploratory efficacy of its novel biologic for patients with dry eye secondary to ocular Graft vs Host Disease (oGvHD). Study results indicated Elate Ocular® biologic as safe, well tolerated and with positive symptoms efficacy. These results, lessons learned incorporated in upcoming study protocols, 30+ years of published outcomes involving autologous/PRP serum drops, and finally continued patient demand for more effective therapeutics for advanced dry eye—all support Cambium’s upcoming Phase III studies. These studies will begin following close of a Series B financing.
“We believe our Elate Ocular® biologic will become the first standardized, FDA approved, commercialized, allogeneic vs autologous, enriched and ultimately reimbursed serum drop for advanced dry eye,” said Terry Walts, Cambium’s President and CEO. “More importantly, Cambium believes symptoms from a complex, multi-factorial disease like dry eye may be better treated by a complex biologic with not one but multiple nutritive/regenerative components—components present and documented important in healthy tear film, corneal homeostasis.” said Walts.
About Cambium Medical Technologies
Founded in 2013 by four distinguished physician/scientists at Emory University, Atlanta, Georgia (USA)—Cambium is focused on the development of regenerative therapies through novel processed human platelets. Cambium’s Mission: To improve patients’ quality of life—from within. The Company’s first FDA-approved therapy is targeted to be Elate Ocular®, a topical biologic eye drop for dry eye disease (keratoconjunctivis sicca or KCS). Elate Ocular® contains Aurarix®, Cambium’s novel processed, fibrinogen depleted platelet-rich-plasma (PRP) lysate. Cambium’s Aurarix® contains over 30 key nutritive/regenerative components documented important to corneal health, present in healthy tear film.
Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended, and within the meaning of the Private Securities Litigation Reform Act of 1995 (the “Act”) and are intended to be covered by the safe harbors created thereby. These forward-looking statements include, but are not limited to, statements regarding the expected benefits of the Company’s technologies, investment in product development, possible future financings or other activities and/or statements preceded by, followed by or that include the words “believes,” “could,” “expects,” “anticipates,” “estimates,” “intends,” “plans,” “projects,” “seeks,” “potential,” “targets” or similar expressions. Investors are cautioned that all forward-looking statements involve known and unknown risks and uncertainties that could cause actual results to differ materially from those expressed or implied in the forward-looking statements for any reason. All forward-looking statements speak only as of the date of this press release and the Company undertakes no obligation to update such forward-looking statements.