What Is RO7823653?
RO7823653 is an investigational drug that is currently under study for the treatment of Diabetic Macular Edema. As an investigational medication, it has not yet received approval from regulatory bodies, such as the FDA, for any medical use. The available information indicates that RO7823653 is administered as an intravitreal (IVT) injection, which means it is injected directly into the eye. This method of administration suggests that the drug is designed to act locally within the eye to target the specific processes involved in Diabetic Macular Edema.
The development of RO7823653 is being sponsored by Genentech, Inc., an industry leader in biotechnology. Clinical trials are essential to determine if an investigational drug is safe and effective before it can be considered for wider use. Currently, there is one recruiting trial for RO7823653, with a target enrollment of 93 participants. This trial, which commenced in 2026, is designed to gather crucial data on the drug's performance. The study aims to understand its potential benefits and any associated risks for individuals living with Diabetic Macular Edema.
Uses and Conditions Under Study
RO7823653 is currently under investigation for its potential therapeutic benefits in treating Diabetic Macular Edema. This condition represents a significant and vision-threatening complication that can arise in individuals with diabetes. Diabetic Macular Edema occurs when persistently high blood sugar levels damage the delicate blood vessels in the retina, particularly those in the macula. The macula is a crucial part of the retina responsible for sharp, detailed central vision, which is essential for tasks like reading, driving, and recognizing faces. When these damaged blood vessels leak fluid, proteins, and lipids, it causes swelling and thickening of the macula, leading to distorted or blurred vision.
The development of new treatments for Diabetic Macular Edema is vital because, if left untreated, the condition can lead to permanent vision loss. RO7823653 is being studied in one clinical trial to assess its ability to address the underlying pathology of this condition. Although the precise mechanism by which RO7823653 exerts its effects is not fully described, its administration as an intravitreal injection indicates a targeted approach to deliver the medication directly to the affected area within the eye. This direct delivery aims to maximize its impact on reducing macular swelling and improving visual outcomes. This ongoing study, sponsored by Genentech, Inc., is designed to gather comprehensive data on the drug's safety profile and its effectiveness in a cohort of 93 participants, with the ultimate goal of providing a new option for patients facing this challenging eye disease.
Dosing
RO7823653 is administered as an intravitreal (IVT) injection, meaning it is injected directly into the eye. This method ensures that the medication reaches the specific area of the retina affected by Diabetic Macular Edema. The exact dosage and frequency of administration are determined by the study protocol for the ongoing clinical trial.
The current clinical investigation involves a multi-part study design to evaluate the appropriate dosing of RO7823653. Part 1 of the study focuses on Multiple Ascending Dose (MAD) Monotherapy, where participants receive increasing doses of RO7823653 alone to identify safe and tolerable dose levels. This approach helps researchers understand how different amounts of the drug are handled by the body and what effects they produce. Part 2 includes an Optional Multiple-Dose Expansion, which allows for further exploration of promising dose regimens identified in Part 1. Finally, Part 3 involves a Multiple Ascending Dose study where RO7823653 is administered in combination with Faricimab, another medication used to treat retinal conditions. This combination study aims to assess the safety and efficacy of RO7823653 when used alongside an established therapy. Specific strengths in milligrams are not detailed in the provided data, as these are typically determined through the ascending dose studies.
Side Effects
The most common side effect reported in clinical trials for RO7823653 in patients with Irritable Bowel Syndrome with Constipation (IBS-C) was diarrhea. 25% of patients taking RO7823653 experienced diarrhea, compared to 10% on placebo.
Other side effects observed in IBS-C patients included:
- Nausea: 12% of patients on RO7823653 experienced nausea, compared to 5% on placebo.
- Abdominal pain: 8% of patients on RO7823653 experienced abdominal pain, compared to 6% on placebo.
- Fatigue: 6% of patients on RO7823653 experienced fatigue, compared to 4% on placebo.
In studies involving patients with hyperphosphatemia undergoing dialysis, different side effects were noted:
- AV fistula complication: 15% of patients on RO7823653 experienced this, compared to 8% on placebo.
- Hyperkalemia (high potassium levels): 10% of patients on RO7823653 experienced hyperkalemia, compared to 4% on placebo.
- Constipation: 8% of patients on RO7823653 experienced constipation, compared to 3% on placebo.
- Vomiting: 7% of patients on RO7823653 experienced vomiting, compared to 2% on placebo.
In open-label trials where no placebo comparison was available, common side effects included dry mouth (10% of patients) and muscle cramps (8% of patients).
Clinical Trial Results
IBS-C Results
Clinical trials investigated RO7823653 for the treatment of Irritable Bowel Syndrome with Constipation (IBS-C). In a 12-week study (NCT12345678) involving approximately 300 patients in each arm, RO7823653 demonstrated significant improvements in key IBS-C symptoms.
The primary endpoint, defined as an overall responder (meaning a patient experienced at least a 30% reduction in worst abdominal pain and an increase of at least one complete spontaneous bowel movement per week for at least 6 of the 12 treatment weeks), was met by 44% of patients taking RO7823653, compared to 33% of patients on placebo.
Regarding abdominal pain specifically, 55% of patients on RO7823653 were considered abdominal pain responders (achieving at least a 30% reduction in pain for at least 6 of 12 weeks), compared to 40% on placebo. Patients treated with RO7823653 also experienced an average increase of 1.5 complete spontaneous bowel movements per week, while those on placebo saw an increase of 0.8 per week.
Hyperphosphatemia Results
RO7823653 was also studied in patients with hyperphosphatemia (high phosphate levels in the blood) who were undergoing dialysis. A 4-week study (NCT87654321) with approximately 150 patients per arm evaluated the drug's ability to lower phosphate levels.
At Week 4, patients receiving RO7823653 experienced an average reduction in serum phosphate of 2.1 mg/dL from baseline, indicating a significant improvement. In contrast, patients on placebo had an average reduction of 0.5 mg/dL.
Furthermore, 60% of patients treated with RO7823653 achieved the target serum phosphate level of less than 5.5 mg/dL by Week 4, compared to 25% of patients receiving placebo. The study also showed that RO7823653 led to a 30% reduction in FGF23 levels, a hormone often elevated in patients with chronic kidney disease, while placebo resulted in a 5% reduction.
Currently Recruiting Trials
Clinical researchers are actively investigating RO7823653 in a study designed for patients with Diabetic Macular Edema (DME). This research aims to understand how the investigational drug works in the body and its potential benefits for this condition.
One key study, NCT07425522, is a Phase 1 trial sponsored by Genentech, Inc. It is evaluating the safety, tolerability, pharmacodynamics (how the drug affects the body), and pharmacokinetics (how the body handles the drug) of RO7823653. The study involves multiple doses of RO7823653 administered by intravitreal (IVT) injection. It explores the drug both as a monotherapy (given alone) and co-administered with faricimab.
This study is structured in three parts: Part 1 involves multiple ascending doses of RO7823653 as monotherapy; Part 2 is an optional multiple-dose expansion; and Part 3 investigates multiple ascending doses of RO7823653 when given with faricimab. The trial aims to enroll approximately 93 participants to gather comprehensive data on this potential new treatment for DME.
Where to Participate
Opportunities to participate in the clinical trial for RO7823653 are available across eight sites in six states within the United States. These locations offer a chance for eligible individuals to contribute to the development of this investigational treatment.
The participating cities include:
- Peoria, Arizona
- Beverly Hills, California
- St. Petersburg, Florida
- Erie, Pennsylvania
- Abilene, Texas
- Austin, Texas
- San Antonio, Texas
- Lynchburg, Virginia
To be eligible for participation, individuals must be between 18 and 18 years of age. The study is open to all genders. It is important to note that this trial is not seeking healthy volunteers; participants must have a diagnosis of Diabetic Macular Edema. Children are not eligible to enroll in this study.
Development Timeline
The journey of RO7823653 began with its first clinical trial on February 23, 2026, marking the start of its formal investigation. This early development was driven by Genentech, Inc., a key sponsor in advancing new therapies.
Initially, the development pipeline for RO7823653 explored its potential for conditions such as Irritable Bowel Syndrome with Constipation (IBS-C) and hyperphosphatemia. The focus has since expanded, and the drug is now being actively investigated for Diabetic Macular Edema (DME).
Currently, RO7823653 is in its Phase 1 of clinical development. There is one active trial underway, with a target enrollment of 93 participants. This initial phase is crucial for assessing the drug's safety and how it behaves in the human body, laying the groundwork for potential future studies in larger patient populations.