HIV Drug Shows Potential as Oral Treatment for Diabetic Macular Edema
The results show promise, as vision typically improves the most during the first 4 weeks, but with lamivudine, vision continued to improve in the following 4 weeks.
Lamivudine (Epivir), a drug used to treat HIV, can help to improve vision for patients with diabetic macular edema (DME), which is a condition that causes a buildup of fluid in the retina. The drug could potentially be an oral option instead of the standard monthly injection directly into the eye.1
The results show promise, as vision typically improves the most during the first 4 weeks, but with lamivudine, vision continued to improve in the following 4 weeks. | Image Credit: Story Images - stock.adobe.com
“An oral drug that improves vision in DME would be a game changer because it would be more convenient for patients than frequent, often monthly, injections into the eye,” Jayakrishna Ambati, MD, founding director of University of Virginia Health’s Center for Advanced Vision Science, said in a news release.1
Investigators found that at 4 weeks, patients treated with lamivudine had an improved best-corrected visual acuity (BCVA) of 9.8 letters and 16.9 letters at 8 weeks compared with a decrease of 1.8 letters with the placebo and an improvement of 5.3 letters with the placebo and bevacizumab, respectively. The study authors also stated that lamivudine was associated with greater BCVA improvement compared with bevacizumab or ranibizumab but was no different from aflibercept. Further, there were no significant differences in retinal thickness or adverse events between the groups.2
“The mechanism of action of lamivudine is different from that of existing treatments, so we could also develop combination therapies. This trial demonstrates that blocking inflammasomes can improve vision in DME. We have developed a safer version of lamivudine called K9, which blocks inflammasomes without the potential side effects of lamivudine,” Ambati said in the news release.1 “So, we are excited by the ongoing and planned clinical trials of K9 in DME as well.”
The study was an 8-week nonrandomized, open-label safety trial that evaluated twice daily oral treatment for 5 individuals. Investigators also assessed safety during a series of postoperative visits over an 8-week period. Patients had a BCVA of between 24 and 68 letters and a diagnosis of either type 1 or type 2 diabetes and nonproliferative or non-high-risk proliferative diabetic retinopathy. Patients received lamivudine in the 96 mg tablet twice a day for 4 weeks. The primary end points included frequency of adverse events and mean change from baseline in BCVA. The secondary outcomes included change from baseline in central subfield thickness and change from baseline in macular volume on spectral domain-optical coherence tomography.3
Investigators plan on future trials to confirm these results, which will include more patients for a longer period than 8 weeks. They note that these results are promising as vision typically improves the most during the first 4 weeks, but with lamivudine treatment, vision continued to improve in the following 4 weeks.1
“A $20-a-month or even cheaper oral pill that improves vision as much as or more than therapy with injections into the eye that cost up to $2000 per month could be transformative both for patients and the health care system,” Ambati said.1
The researchers have also found data that nucleoside reverse transcriptase inhibitors could also reduce the risk of diabetes and macular degeneration.1
READ MORE: Diabetes Resource Center
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REFERENCES
1. Drug Improves Sight for Diabetic Macular Edema Patients. News release. UVA Health. May 27, 2025. Accessed May 29, 2025. https://newsroom.uvahealth.com/2025/05/27/drug-improves-sight-for-diabetic-macular-edema-patients
2. Pereira F, Magagnoli J, Ambati M, et al. Oral lamivudine in diabetic macular edema: A randomized, double-blind, placebo-controlled clinical trial. Med. Published online May 23, 2025. doi:10.1016/j.medj.2025.100747
3. Evaluation of K9 in Subjects With Diabetic Macular Edema (DME). ClinicalTrials.gov identification: NCT06781255. March 17, 2025. Accessed May 29, 2025. https://clinicaltrials.gov/study/NCT06781255
