QA102 data suggest signal in intermediate dry AMD, but insignificant drusen volume change

The phase 2 QA102-CS201 study (NCT05536752) of QA102, an investigational oral therapy for intermediate dry age-related macular degeneration (AMD), showed effects on several imaging-based progression measures but did not meet its primary efficacy end point of change in baseline soft drusen volume.¹ The results were presented at the Association for Research in Vision and Ophthalmology (ARVO) meeting in Denver, Colorado, from May 4-7, 2026. This update is notable because QA102 is the first drug candidate portraying efficacy signals in intermediate dry AMD, a stage associated with increased risk of progression to geographic atrophy (GA) or neovascular AMD (nAMD).^2,3

“Intermediate AMD represents the most prevalent stage of the disease, yet remains an area of significant unmet medical need with a lack of therapies to slow or prevent progression,” Scott Whitcup, MD, said in the release. The company also quoted principal investigator Sunil Patel, MD, PhD, from Abeline Surgery Center, who described the findings as “very encouraging” for patients with intermediate or advanced dry AMD.¹

According to MingMed Biotechnology,¹ the QA102-CS201 trial enrolled 150 patients with intermediate atrophic AMD and randomly assigned them 1:1:1 to QA102 200 mg, QA102 400 mg, or placebo twice daily for up to 15 months. The study was described as double-masked, randomized, and placebo-controlled.

What did the QA102-CS201 study find?

After 12 months of treatment, the company reported that mean change in drusen volume was reduced by 59.2% in the QA102 400-mg group relative to placebo, however the primary efficacy end point did not show a statistically significant difference between groups. Reported secondary or exploratory findings favored the higher-dose group, with a 118.2% reduction in drusen volume growth rate vs placebo (P = .017) and a 42.7% reduction in square root–transformed GA area growth rate (P = .026).¹

“Drusen volume was not an FDA-approved endpoint when this Phase II study began in 2022, and it was not yet clear which clinical endpoint would be most sensitive to treatment or how the FDA would view it,” Patel said in an exchange with Ophthalmology Times. “We therefore selected drusen volume as the primary endpoint and included several key secondary endpoints. Although the primary endpoint did not reach statistical significance, QA102 showed a strong dose-dependent numerical trend toward reducing drusen volume, with a p-value of 0.089.”

The Age-Related Eye Disease Study established progression risk categories and showed the benefit of antioxidant plus zinc supplementation in selected patients with at least intermediate AMD, but nutritional therapy has not been shown to reverse drusen burden or clearly halt atrophic progression.² More recently, intravitreal complement inhibitors have been approved for GA secondary to AMD, but these agents are indicated for established GA rather than the intermediate stage and require repeated injections. An effective oral therapy that delays structural progression earlier in disease would therefore address a clear gap if confirmed in larger studies. Fred Ouyang, PhD, chief technology officer of MingMed Biotechnology, called QA102 a “first-in-class oral therapy for atrophic AMD,”¹ but did not disclose the drug’s mechanism of action.

The company said QA102 showed an "acceptable safety profile” but did not report discontinuation rates, serious adverse events, or laboratory findings. Subsequent reporting from Patel has shed light on the drug's tolerability profile. He mentioned the most frequent side effects observed were gastrointestinal—mostly mild or moderate diarrhea, with an overall occurrence rate of 14.7%. These events resolved upon discontinuation of the medication and appeared to be independent of dose, suggesting a possible hypersensitivity mechanism rather than a direct drug effect. Patel noted that patients should be counseled about these potential side effects and that future trials may consider excluding those with a history of recurrent diarrhea or specific GI illnesses.

References

1. MingMed Biotechnology Co., Ltd. MingMed Biotechnology presents positive Phase II data of oral QA102 for the treatment of intermediate age-related macular degeneration (AMD) at Association for Research in Vision and Ophthalmology (ARVO) 2026. PR Newswire. May 5, 2026. Accessed May 8, 2026. https://www.prnewswire.com/news-releases/mingmed-biotechnology-presents-positive-phase-ii-data-of-oral-qa102-for-the-treatment-of-intermediate-age-related-macular-degeneration-amd-at-association-for-research-in-vision-and-ophthalmology-arvo-2026-302763402.html

2. Age-Related Eye Disease Study Research Group. A randomized, placebo-controlled, clinical trial of high-dose supplementation with vitamins C and E, beta carotene, and zinc for age-related macular degeneration and vision loss. AREDS report No. 8. Arch Ophthalmol. 2001;119(10):1417-1436. doi:10.1001/archopht.119.10.1417

3. Ferris FL III, Wilkinson CP, Bird A, et al. Clinical classification of age-related macular degeneration. Ophthalmol. 2013;120(4):844-851. doi:10.1016/j.ophtha.2012.10.036