Risuteganib
Risuteganib (ALG-1001, Luminate), intravitreal integrin regulating peptide
Written by Aaron CuhaReviewed Sep 2026
Also known as: ALG-1001, Luminate
An intravitreal anti-integrin peptide for dry macular degeneration and diabetic macular oedema. Six phase 2 trials in about 435 people; a 45 person dry AMD trial reported 48 percent versus 7 percent gaining 8 letters, using an asymmetric comparison. No phase 3 has been registered and the last trial completed in 2019.
Overview
Risuteganib is a synthetic peptide injected into the eye that binds several integrin heterodimers implicated in retinal oxidative stress and abnormal blood vessel growth. Allegro Ophthalmics developed it under the code ALG-1001 and the brand Luminate for diabetic macular oedema (DME) and non-exudative (dry) age-related macular degeneration, a condition with very few approved treatments.
What has been measured in people: six registered trials, all phase 1/2 or phase 2, all completed or withdrawn. The largest, a 218 participant DME trial against bevacizumab (NCT02348918), posted results on the registry in 2018 without a statistical analysis: mean change in best corrected visual acuity at week 24 was +5.2 letters with 1.0 mg risuteganib, +2.7 with 2.0 mg and -1.5 with 3.0 mg, against +7.0 letters with bevacizumab. The published dry AMD phase 2a (2021) enrolled 45 people and analysed 39: 48 percent of the risuteganib arm gained 8 or more ETDRS letters at week 28, against 7 percent of the sham arm at week 12. That comparison is asymmetric by design, measuring the treated arm 16 weeks later than the sham arm, which the paper acknowledges but which makes the 48 versus 7 figure hard to interpret. No drug related adverse events were reported over 32 weeks. A 2020 review in Expert Opinion on Investigational Drugs states that more data are needed before the benefit of adopting risuteganib can be evaluated.
In cells, risuteganib protected human retinal pigment epithelium against hydroquinone and hydrogen peroxide injury and behaved differently from bevacizumab in cybrid cells carrying mitochondria from AMD patients. No phase 3 has been registered as of September 2026, the most recent trial completed in April 2019, and risuteganib is not approved anywhere.
Mechanism of action
In people, the mechanism has not been measured directly; the trials recorded visual acuity, and in exploratory analyses, colour vision and microperimetry. Nothing links a change in integrin signalling in a human retina to the visual acuity results. In vitro, risuteganib binds multiple integrin heterodimers rather than one, and in retinal pigment epithelial cell lines it reduced oxidative stress induced death, preserved mitochondrial membrane potential and shifted expression of apoptosis, oxidative stress and inflammation genes. In transmitochondrial cybrid cells built with mitochondria from AMD donors, it reduced markers of cell death where bevacizumab did not. The proposed clinical rationale is that integrins sit upstream of both the vascular leakage of DME and the oxidative, mitochondrial injury of dry AMD, which is why one molecule was tried in both.
Human evidence
About 435 people have received intravitreal risuteganib across six phase 1/2 and phase 2 trials between 2012 and 2019. One trial has been published in full, in 45 people, and the largest trial's results exist only as numbers posted on the registry.
- Dry AMD phase 2a (2021): 45 randomised, 39 analysed. 48 percent gained 8 or more letters at week 28 on risuteganib versus 7 percent on sham at week 12. The asymmetric timing is part of the design. No drug related adverse events over 32 weeks.
- DME phase 2 versus bevacizumab (NCT02348918): 218 participants. Posted week 24 acuity changes of +5.2, +2.7 and -1.5 letters at 1.0, 2.0 and 3.0 mg versus +7.0 for bevacizumab. No statistics posted, no publication.
- NCT02435862: 105 participants, inducing posterior vitreous detachment in non-proliferative diabetic retinopathy, completed 2017, no results posted.
- NCT02153476: 45 participants with symptomatic vitreomacular adhesion, completed 2015, results posted 2018.
- NCT01749891: 25 participants with wet AMD, phase 1/2, completed 2013, no results posted. NCT01482871: phase 1/2 in DME, withdrawn with no enrolment.
- Post hoc and exploratory analyses of the 39 dry AMD completers report OCT predictors of response and trends in colour vision and microperimetry.
What this does not tell you: The headline 48 versus 7 percent compares the treated arm at week 28 with the sham arm at week 12, so it does not tell you what sham would have done at week 28, and 39 analysed eyes cannot establish an effect size. In DME the posted numbers favour bevacizumab and show acuity falling at the highest dose, with no analysis to say whether any of that is noise. No trial has run longer than 32 weeks, no trial has measured progression of geographic atrophy, and no phase 3 has been registered. Absence of drug related adverse events in 45 people is not a safety profile for an injection into the eye.
Reading the research record
Risuteganib is a case where the question is not whether anyone will fund the trials but why the sponsor that did has not gone further. Allegro Ophthalmics owns the molecule and ran six trials, the last of which completed in April 2019. Since then there have been publications from the dry AMD dataset, including two exploratory re-analyses of the same 39 patients, but no phase 3 registration and no publication of the 218 person DME trial, whose posted numbers numerically favour the comparator. In a field where anti-VEGF drugs set a high bar in DME and where dry AMD has since gained approved complement inhibitors, a phase 2 result from 2019 gets harder to build on each year.
The reviewer in Expert Opinion on Investigational Drugs put it plainly in 2020: more data are needed before adoption can be evaluated, and in DME the drug must show it adds to existing treatment. Nothing published since answers either point. The in vitro mitochondrial work is genuine and NIH supported, and it is the reason risuteganib appears in longevity and antioxidant catalogues; but it is cell work, and the molecule has only ever been injected into eyes. There is no systemic human exposure data at all.
The evidence, charted
Fig. 1 · evidence composition
4of 6 citations (67%) are in people
Counted from the citation list on this page. The Human count is the same number shown in the badge at the top. Both understate any literature larger than the sources we cite.
Fig. 2 · evidence over time
Evidence spans 4 distinct years, 2014 to 2022, counted from the citation list on this page.
Fig. 3 · legal status at a glance
US
Not approved
UK
Approved
AU
Approved
CA
Not approved
Approved in 2 of 4, prescription route in 0, not approved in 2. A jurisdiction's classification is a regulatory fact, not a verdict on the science; see Legal status below for the full text and any notes.
Key studies & citations
- Human2021
Safety and Efficacy of Intravitreal Risuteganib for Non-Exudative AMD: A Multicenter, Phase 2a, Randomized, Clinical Trial
45 people with dry AMD and vision between 20/40 and 20/200 randomised to 1.0 mg intravitreal risuteganib (29) or sham (16); 39 completed. Primary endpoint, a gain of 8 or more ETDRS letters, was met by 48 percent of the risuteganib arm at week 28 versus 7 percent of the sham arm at week 12. The two arms were measured at different times by design. No drug related adverse events in 32 weeks. Developer funded; the registered trial (NCT03626636) lists 42 participants.
Ophthalmic Surgery, Lasers and Imaging Retina - Human2014
Phase 2 Randomized Clinical Trial of Luminate as Compared to Avastin in the Treatment of Diabetic Macular Edema (NCT02348918)
218 participants with DME across nine arms. Posted results (December 2018): mean change in best corrected visual acuity at week 24 of +5.2 letters (1.0 mg), +2.7 (2.0 mg) and -1.5 (3.0 mg) with risuteganib, versus +7.0 with bevacizumab. No statistical comparison posted and no journal publication located. Sponsor funded.
ClinicalTrials.gov, Allegro Ophthalmics - Human2022
Impact of Baseline Quantitative OCT Features on Response to Risuteganib for the Treatment of Dry Age-Related Macular Degeneration: The Importance of Outer Retinal Integrity
Post hoc analysis of the 39 completers of the phase 2a. Eyes with more intact ellipsoid zone, thicker outer retina and less geographic atrophy at baseline were more likely to gain 8 letters. Exploratory, and proposed by the authors as a way to enrich future trials. NIH supported analysis.
Ophthalmology Retina - Human2022
Color Vision and Microperimetry Changes in Nonexudative Age-Related Macular Degeneration After Risuteganib Treatment: Exploratory Endpoints in a Multicenter Phase 2a Trial
Exploratory endpoints from the same 39 patients. Colour vision and microperimetry measures trended toward improvement; two of the metrics reached statistical significance. Exploratory analyses of a 39 person trial.
Ophthalmic Surgery, Lasers and Imaging Retina - Review2020
Risuteganib, a novel integrin inhibitor for the treatment of non-exudative (dry) age-related macular degeneration and diabetic macular edema
Narrative review of the phase 1 and 2 data. The expert opinion section states that more data are needed before the benefits of adopting risuteganib can be evaluated, and that in DME it must show it adds to existing treatments, especially in refractory disease.
Expert Opinion on Investigational Drugs - In vitro2021
Differential effects of risuteganib and bevacizumab on AMD cybrid cells
Retinal pigment epithelial cybrid cell lines carrying mitochondria from 5 AMD and 3 normal donors treated with clinical dose equivalents of each drug for 48 hours. AMD cybrids had higher baseline caspase activity; the two drugs produced different patterns of apoptosis, oxidative stress and inflammation gene expression. Cell work only. NIH and foundation funded.
Experimental Eye Research
Frequently asked questions
Does risuteganib improve vision in dry AMD?
In a 45 person phase 2a, 48 percent of treated eyes gained 8 or more letters at week 28, against 7 percent of sham eyes measured at week 12. The two arms were measured at different times by design, and only 39 eyes were analysed. That is a signal worth a larger trial, and no larger trial has been registered.
How did it compare with Avastin in diabetic macular oedema?
In the 218 person phase 2 posted on ClinicalTrials.gov, week 24 acuity rose 5.2 letters at the 1.0 mg dose and 7.0 letters with bevacizumab; the higher risuteganib doses did worse, and the 3.0 mg arm lost 1.5 letters. No statistical analysis was posted and the trial has not been published.
Is there a phase 3?
No. As of September 2026 no phase 3 trial of risuteganib is registered, and the most recent trial of any phase completed in April 2019.
Why is an eye drug in a longevity catalogue?
Because of cell studies showing it protects retinal pigment epithelium from oxidative injury and alters mitochondrial function markers. Those are in vitro findings. Risuteganib has only ever been given to people by injection into the eye, and there is no human data on any systemic or anti-aging use.