Biopharmaceutical company for ocular diseases Allegro Ophthalmics, LLC announced yesterday positive results of an ex-U.S. proof-of-concept clinical trial of the new investigational drug candidate in patients with dry eye disease (DED). Results for the topical drop integrin inhibitor ALG-1007 were presented by Eric D. Donnenfeld, M.D., last week at the 2019 American Society of Cataract and Refractive Surgery and American Society of Ophthalmic Administrators (ASCRS•ASOA) Annual Meeting in San Diego, CA.
The ex-U.S. proof-of-concept clinical trial concluded that ALG-1007 demonstrated a dose response, indicating that the active pharmaceutical ingredient (API) in ALG-1007 is effective in improving the signs and symptoms of DED with improvement as early as two weeks. At the highest dose concentration (0.6%), ALG-1007 demonstrated statistically significant efficacy in nearly all assessments and a more rapid onset of action compared to the lowest dose (0.125%). ALG-1007 was well-tolerated with no drug-related adverse events, even at the highest dose, and there was no reported blurring of vision or ocular irritation, even at the time of application.
The trial enrolled 40 eyes of 21 patients diagnosed with DED for at least six months. Patients were assigned to one of four treatment doses (n=10, each group): 0.125%, 0.25%, 0.4% and 0.6% of ALG-1007 in a lubricating ophthalmic topical solution. Topical treatment was administered as one drop two times per day, and subjects were followed at multiple timepoints for 12 weeks. Outcome measures were tear break-up time (TBUT), SICCA total ocular staining score, corneal and nasal conjunctival staining score, and reported symptoms using the visual analog scale (VAS) symptom index.
“This early ex-U.S. proof-of-concept data looks promising, especially at the higher 0.6% ALG-1007 dose. My fellow Allegro Cornea SAB members and I were particularly impressed by how well-tolerated the drug seems to be,” said Dr. Donnenfeld, founding partner of Ophthalmic Consultants of Long Island and Ophthalmic Consultants of Connecticut. “Dry eye is a multifactorial disease and there remain unmet needs for a very large patient population. It will be interesting to see the outcomes of the second, larger ex-U.S. study, which is exploring the drug’s efficacy and safety in even higher concentrations.”
News source: https://www.allegroeye.com/allegro-ophthalmics-expands-its-anti-integrin-portfolio-with-new-front-of-the-eye-drug-candidate-alg-1007-for-the-treatment-of-dry-eye-disease-3-2/