ALG-1007 / Allegro Ophthalmics - LARVOL DELTA

Allegro Ophthalmics Announces Positive Results of Vehicle-controlled Ex-U.S. Phase 2 Trial of ALG-1007 for the Treatment of Dry Eye Disease (Businesswire) - '"I'm very encouraged by the results of this trial, which demonstrated that ALG-1007 had the most robust improvement in signs and symptoms of dry eye compared to the comparator arms,' said Dr. Donnenfeld...'The components in ALG-1007 appear to have synergistic effects. It should be emphasized that no adverse events, ocular irritation, or prolonged blurred vision were reported in the study - an impressive finding.'"

Media quote

Safety and Efficacy of a Novel Integrin Inhibitor, ALG-1007 Topical Solution, for the Treatment of Dry Eye Disease (AAO 2019) - "A Phase 2 study has been initiated using higher doses. Results from the study will also be presented."

Clinical

Allegro Ophthalmics to present clinical research on the company’s novel integrin-regulating portfolio at the American Academy of Ophthalmology Annual Meeting (Businesswire) - "Allegro Ophthalmics, LLC, a privately held biopharmaceutical company focused on the development of novel therapies that regulate select integrin functions for the treatment of ocular diseases, today announced that the results of its US Phase 2 clinical stud...In addition to the risuteganib Phase 2 intermediate dry AMD data, on Saturday, October 12, Richard L. Lindstrom, M.D., will present the results of its ALG-1007 ex-U.S. proof-of-concept trial for the treatment of dry eye disease."

Allegro Ophthalmics to present clinical research on the Company’s novel integrin-regulating portfolio at the American Academy of Ophthalmology Annual Meeting (Yahoo Finance) - "Allegro Ophthalmics, LLC...announced that the results of its US Phase 2 clinical study of risuteganib (Luminate®) for the treatment of intermediate nonexudative age-related macular degeneration (dry AMD) will be presented during AAO 2019, the American Academy of Ophthalmology’s 123rd annual meeting that is being held October 11- 15 in San Francisco, CA....Richard L. Lindstrom, M.D., will present the results of its ALG-1007 ex-U.S. proof-of-concept trial for the treatment of dry eye disease."

Clinical data • P2 data

Safety and Efficacy of a Novel Integrin Inhibitor, ALG-1007 Topical Solution, for the Treatment of Dry Eye Disease (AAO 2019) - No abstract available.

Clinical

Video: New drug for dry eye shows promise in preliminary study (Healio) - "Eric D. Donnenfeld, MD, speaks about ALG-1007 (Allegro Ophthalmics), a new integrin regulator that inhibits the complement cascade of inflammation in dry eye disease. The initial proof-of-concept first-in-human study shows promise."

Video

Safety and efficacy of a novel integrin inhibitor ALG-1007 topical ophthalmic solution for the treatment of dry eye disease (ESCRS 2019) - "This study demonstrates that ALG-1007 exhibits a dose response curve with clinical and statistically significant efficacy in multiple objective and subjective measures. Although the study does not have a vehicle control, the results indicate that the active ingredient (not the vehicle) is effective in improving signs and symptoms of DED in a statistically significant manner when comparing the 0.125% dose vs the 0.6% dose. The drug was well-tolerated with no drug-related SAEs, blurring of vision nor ocular irritation."

Clinical

Discussion (ESCRS 2019) - "This study demonstrates that ALG-1007 exhibits a dose response curve with clinical and statistically significant efficacy in multiple objective and subjective measures. Although the study does not have a vehicle control, the results indicate that the active ingredient (not the vehicle) is effective in improving signs and symptoms of DED in a statistically significant manner when comparing the 0.125% dose vs the 0.6% dose. The drug was well-tolerated with no drug-related SAEs, blurring of vision nor ocular irritation."

Allegro Ophthalmics to present the results of its phase 2 risuteganib intermediate dry age-related macular degeneration study at the 19th EURETINA Congress and The Retina Society 2019 annual meeting (Businesswire) - "Allegro Ophthalmics...announced that the results of its U.S. Phase 2 study evaluating risuteganib (Luminate®) for the treatment of intermediate nonexudative age-related macular degeneration...will be presented during the 19th European Society of Retina Specialists (EURETINA) Congress that is being held September 5-8 in Paris, France and at The Retina Society 2019 Annual Meeting, which is being held September 11-15 in London, UK....Allegro also announced that the results of its ALG-1007 ex-U.S. proof-of-concept clinical trial for the treatment of dry eye disease (DED) will be presented during the 37th Congress of the European Society of Cataract and Refractive Surgeons (ESCRS), which is being held September 14-18 in Paris, France."

Clinical data • P2 data

Novel compound shows promise for dry eye in proof-of-concept study (Ophthalmology Times) - "Eric D. Donnenfeld, MD, FAAO, shares results from an ex-U.S. proof-of-concept study investigating a novel, small peptide anti-integrin topical therapy (ALG-1007, Allegro Ophthalmics) for the treatment of dry eye disease. He presented his research at the 2019 annual ASCRS meeting in San Diego."

Video

Reporter’s ASCRS notebook: Five things in dry eye, MIGS, imaging, and mydriatics (Ophthalmology Innovation Summit) - "Eric D. Donnenfeld, MD, presented results of an ex-US proof-of-concept clinical trial of Allegro Ophthalmics’ new investigational topical anti-integrin candidate, ALG-1007, in patients with dry eye disease (DED). The trial concluded that ALG-1007 demonstrated a dose response, indicating that the active pharmaceutical ingredient 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, ALG-1007 demonstrated statistically significant efficacy in nearly all assessments and a more rapid onset of action compared with the lowest dose. ALG-1007 was well tolerated with no drug-related adverse events, and there was no reported blurring of vision or ocular irritation."

Eric D. Donnenfeld, MD, FAAO - ASCRS 2019 (YouTube) - "Eric D. Donnenfeld, MD, FAAO, shares results from an ex-U.S. proof-of-concept study investigating a novel, small peptide anti-integrin topical therapy (ALG-1007, Allegro Ophthalmics) for the treatment of dry eye disease. He presented his research at the 2019 annual ASCRS meeting in San Diego."

Video

Allegro Ophthalmics announces positive results of Ex-U.S. proof-of-concept trial with integrin inhibitor ALG-1007 for dry eye disease (Businesswire) - "'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...'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'....The Allegro Cornea Scientific Advisory Board (SAB) includes Drs. Richard L. Lindstrom, Edward J. Holland and Eric D. Donnenfeld."

Media quote

Allegro Ophthalmics announces positive results of Ex-U.S. proof-of-concept trial with integrin inhibitor ALG-1007 for dry eye disease (Businesswire) - "Allegro Ophthalmics...announced positive results of an ex-U.S. proof-of-concept clinical trial of the new investigational ALG-1007 topical drop drug candidate in patients with dry eye disease (DED). The results 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...Annual Meeting in San Diego...early results suggest that ALG-1007 improves the signs and symptoms of dry eye, a disease that affects millions of people globally, with symptoms that include scratchy, stinging or burning sensations, and pain or redness in the eye...Allegro has initiated a second and larger double-masked, vehicle-controlled ex-U.S. Phase 2 clinical trial, results of which are anticipated in the second half of 2019.”"

P2 data

Allegro Ophthalmics to present the results of its ALG-1007 Ex-U.S. trial for dry eye disease at the 2019 ASCRS•ASOA Annual Meeting (Allegro Ophthalmics Press Release) - "Allegro Ophthalmics...today announced that the results of its ALG-1007 ex-U.S. proof-of-concept clinical trial for the treatment of dry eye disease (DED) will be presented during the 2019 American Society of Cataract and Refractive Surgery and American Society of Ophthalmic Administrators (ASCRS•ASOA) Annual Meeting being held May 3-7 in San Diego, CA....Then on Monday, May 6, Eric D. Donnenfeld, M.D., will present full study results of the ALG-1007 ex-U.S. proof-of-concept clinical trial for DED at ASCRS•ASOA."

Clinical data

Newly added product (Allegro Ophthalmics Press Release) - P2, Dry Eye Disease

Pipeline update