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StocksMediumUpdated×5•Originally published 19 October 2026•Updated 19 October 2026•
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Disc Medicine reports 41.4% reduction in protoporphyrin measure versus placebo in APOLLO

Key Facts

1The difference versus placebo in the change in protoporphyrin was minus 41.4%, with a p-value of less than 0.0001 in the APOLLO trial.
2Average monthly time in light without pain increased by 12.2 hours versus placebo during the final month of treatment.
3EyePoint management approved a workforce reduction of about 53% as part of its reprioritization.
4EyePoint estimates annual savings from the restructuring at about $30 million.
5Disc plans to resubmit its application for bitopertin approval to the U.S. Food and Drug Administration by the end of 2026.

Disc Medicine said its experimental drug bitopertin achieved a difference of minus 41.4% versus placebo in the change in whole-blood metal-free protoporphyrin in results from the APOLLO trial announced in October 2026. The company said the trial met all its primary and secondary endpoints, a step linked to its application for U.S. Food and Drug Administration approval. The study targeted erythropoietic protoporphyria and also included X-linked protoporphyria. The randomized, double-blind trial enrolled 183 patients and compared the drug with placebo, according to the company's statement. Participants in the bitopertin group received a daily oral dose of 60 mg over a treatment period of 6 months. The p-value for the difference in the change from baseline in the measure was less than 0.0001, according to the results announced by the company.

Disc said average monthly time patients could spend in light without pain increased by 12.2 hours compared with placebo. The difference was recorded during the final month of treatment in APOLLO, among the results the company presented on the drug's effects in participants. On safety, dizziness was the most common treatment-emergent adverse event among bitopertin recipients, occurring in 50% of that group. The company described the dizziness as generally mild or moderate and transient during treatment. It said in its results statement that "no new safety signals were observed," while bitopertin remains an experimental drug that is not approved for therapeutic use in any country.

Bitopertin is designed to modulate heme biosynthesis, according to Disc's description of the drug in its earlier update on discussions with the U.S. regulator. The company obtained worldwide rights to the drug under a licensing agreement with Roche signed in May 2021. The APOLLO results were preceded by regulatory discussions following an earlier complete response letter, according to Disc's update on its meeting with the FDA. The company said it agreed with the agency that a successful trial "could support traditional approval," the wording it used to link the study results to the regulatory pathway. The new results thus form part of an application process that previously received a complete response letter, with the drug remaining experimental until approval for its use is granted.

In another clinical program, EyePoint said the LUCIA trial of DURAVYU missed its primary endpoint despite improved vision among participating patients. The endpoint was to demonstrate non-inferiority in the change in best-corrected visual acuity compared with aflibercept, according to the company's results statement. The trial recorded a 38% reduction in treatment burden among its secondary endpoints, with the company describing the statistical significance of that result as nominal. In addition, 52% of eyes required no supplemental treatment during the reported follow-up period, according to the same statement. LUCIA enrolled about 475 patients, compared with 432 patients in the LUGANO trial within the clinical program presented by the company. The primary visual acuity endpoint remained unmet as these secondary results on treatment burden and the need for supplemental treatment were announced.

As part of a reprioritization, EyePoint management approved a plan that includes reducing its workforce by about 53%, according to the company's statement on its strategic shift. The company estimates annual savings from the restructuring at about $30 million once the plan is implemented. It expects to incur total charges of approximately $9 million for severance and related expenses. The reprioritization decisions include ending wet macular degeneration trials early, according to the company's announcement on the program's future. EyePoint will direct resources toward its diabetic macular edema program, linking the shift in clinical spending with the staff and cost reductions announced under the plan.

Disc's next regulatory milestone is the resubmission of its new drug application for bitopertin to the U.S. Food and Drug Administration. The company set the end of 2026 as its target for that step, according to its statement accompanying the APOLLO results. Disc expects an agency decision on the drug by mid-2027, according to its announced timeline. In the program to which EyePoint will direct resources, the company is awaiting results from pivotal DURAVYU trials for diabetic macular edema. It expects to announce those results in the fourth quarter of 2027, under its announced plan to reprioritize clinical programs and spending.