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Purpose <p>In the pivotal PHOTON trial of patients with diabetic macular edema (DME), aflibercept 8 mg administered every 12 (8q12) and 16 (8q16) weeks demonstrated similar visual and anatomic outcomes with no new safety signals to aflibercept 2 mg every 8 weeks (2q8). We conducted a prespecified subgroup analysis to assess the efficacy, durability, and safety of aflibercept 8 mg in the Japanese patients from PHOTON.</p> Study design <p>Prespecified subgroup analysis of the Phase 3 PHOTON trial (NCT04429503).</p> Methods <p>Adult patients with DME were randomized 1:2:1 to receive intravitreal aflibercept 2q8, 8q12, or 8q16 following initial monthly doses. Patients randomized to 8q12 and 8q16 were eligible for dose regimen modification. The primary endpoint was change from baseline in best-corrected visual acuity (BCVA) at Week 48. Prespecified efficacy and safety outcomes at/through Week 48 are reported, segmented by Japan versus the rest of world (non-Japan).</p> Results <p>In the Japan and non-Japan subgroups, respectively, mean changes in BCVA were +7.0 and +9.0 (8q12), +7.4 and +7.9 (8q16), and +8.0 and +9.4 (2q8) letters at Week 48; differences in least squares means were -0.30 and -0.64 letters between 8q12 and 2q8 and +0.17 and -1.76 letters between 8q16 and 2q8; ocular treatment-emergent adverse events were reported in 32.4% and 31.6% (8q12), 35.3% and 28.8% (8q16), and 30.0% and 27.2% (2q8) of patients.</p> Conclusion <p>Improvements in BCVA at Week 48 were generally similar with aflibercept 8 mg versus 2 mg in this subgroup analysis of Japanese and non-Japanese patients with DME, suggesting that the primary findings from PHOTON may be generalized to the Japanese population.</p>

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Intravitreal aflibercept 8 mg in patients from Japan with diabetic macular edema: 48-week subgroup analysis of the PHOTON trial

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  • 发表日期：

    2025年12月26日

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  • Kiyoshi Suzuma,
  • Toshinori Murata,
  • Masahiko Shimura,
  • Shigeo Yoshida,
  • Genichiro Kishino,
  • Alyson J. Berliner,
  • Karen W. Chu,
  • Kimberly Reed,
  • Robert Vitti,
  • Yenchieh Cheng,
  • Delia Voronca,
  • Rafia Bhore,
  • Sergio Leal,
  • Peter Morgan-Warren,
  • Andrea Schulze,
  • Ursula Schmidt-Ott,
  • Masato Kobayashi,
  • Taiji Sakamoto,
  • Prema Abraham,
  • Christopher,
  • Aderman,
  • Kunihiko Akiyama,
  • Daniel V. Alfaro,
  • Fareed A. Ali,
  • Payam Amini,
  • Andres Emanuelli Anzalotta,
  • György Bátor,
  • Adam Berger,
  • Ramanath Bhandari,
  • William Bridges,
  • Christian Brinkmann,
  • David M. Brown,
  • Jamin Brown,
  • Stuart Burgess,
  • Jorge Calzada,
  • Antonio Capone Jr.,
  • Dana Cervena,
  • Steven Charles,
  • Nauman Chaudhry,
  • David Chow,
  • W. Lloyd Clark,
  • Paul Conrad III,
  • Matthew Cunningham,
  • Hajir Dadgostar,
  • Amr Dessouki,
  • Dana Deupree,
  • Christopher Devine,
  • Diana Do,
  • David Eichenbaum,
  • Jan Ernest,
  • Nicolas Feltgen,
  • Moss Fenberg,
  • Philip Ferrone,
  • Ronald Frenkel,
  • Scott Friedman,
  • Julie Gasperini,
  • Adam Gerstenblith,
  • Ghassan Ghorayeb,
  • Michel Giunta,
  • Mitchell Goff,
  • Liliya Golas,
  • Joseph M. Googe Jr.,
  • Jordana Goren Fein,
  • Curtis Hagedorn,
  • Akira Hagiwara,
  • Paul Hahn,
  • Richard Hairston,
  • Jason Handza,
  • Vivienne Hau,
  • Ken Hayashi,
  • Jeffrey Heier,
  • Vrinda Hershberger,
  • Patrick Higgins,
  • Yoshio Hirano,
  • Shigeru Honda,
  • Yasuko Ikegami,
  • Yuichiro Ishida,
  • Isao Ishikawa,
  • Kiyoshi Ishii,
  • Eric P. Jablon,
  • Atul Jain,
  • Sunir Joshi,
  • Yuichi Kaji,
  • Kapil Kapoor,
  • Ágnes Kerényi,
  • Kazuhiro Kimura,
  • Genichiro Kishino,
  • Katalin Kiss,
  • Takashi Kitaoka,
  • James M. Klancnik,
  • Namie Kobayashi,
  • Jiro Kogo,
  • Vladimir Korda,
  • Erik Kruger,
  • Sentaro Kusuhara,
  • Wilfredo Lara,
  • Ketan Laud,
  • Seong Lee,
  • James Luu,
  • Dennis Marcus,
  • Calvin Mein,
  • Annal Meleth,
  • Tibor Milibák,
  • Yoshinori Mitamura,
  • Toshinori Murata,
  • Sumiyo Noge,
  • Hajime Onoe,
  • James Osher,
  • András Papp,
  • Justin Parschauer,
  • Sugat Patel,
  • Sunil Patel,
  • Matthew Pezda,
  • Ashkan Pirouz,
  • Pradeep Prasad,
  • Omar Punjabi,
  • Llewelyn Rao,
  • Richard Roe,
  • Taiji Sakamoto,
  • Hani Salehi-Had,
  • Ramin Schadlu,
  • Eric Schneider,
  • András Seres,
  • Ankur Shah,
  • Milan Shah,
  • Sandeep Shah,
  • Sumit Shah,
  • Ashish Sharma,
  • Veeral Sheth,
  • Masahiko Shimura,
  • Lawrence Singerman,
  • Sobha Sivaprasad,
  • Georg Spital,
  • Robert Stoltz,
  • Eric Suan,
  • Kiyoshi Suzuma,
  • Hidenori Takahashi,
  • Yoshihiro Takamura,
  • Masaru Takeuchi,
  • Jeffrey Tan,
  • Benjamin Thomas,
  • Edit Tóth-Molnár,
  • Tetsuo Ueda,
  • Hiroaki Ushida,
  • Attila Vajas,
  • Deepali Varma,
  • Balázs Varsányi,
  • Miroslav Veith,
  • Pamela Weber,
  • Raymond Wee,
  • Geoff Williams,
  • Peter Win,
  • Charles Wykoff,
  • Haruhiko Yamada,
  • Yoshihiro Yonekawa,
  • Shigeo Yoshida

摘要

Purpose

In the pivotal PHOTON trial of patients with diabetic macular edema (DME), aflibercept 8 mg administered every 12 (8q12) and 16 (8q16) weeks demonstrated similar visual and anatomic outcomes with no new safety signals to aflibercept 2 mg every 8 weeks (2q8). We conducted a prespecified subgroup analysis to assess the efficacy, durability, and safety of aflibercept 8 mg in the Japanese patients from PHOTON.

Study design

Prespecified subgroup analysis of the Phase 3 PHOTON trial (NCT04429503).

Methods

Adult patients with DME were randomized 1:2:1 to receive intravitreal aflibercept 2q8, 8q12, or 8q16 following initial monthly doses. Patients randomized to 8q12 and 8q16 were eligible for dose regimen modification. The primary endpoint was change from baseline in best-corrected visual acuity (BCVA) at Week 48. Prespecified efficacy and safety outcomes at/through Week 48 are reported, segmented by Japan versus the rest of world (non-Japan).

Results

In the Japan and non-Japan subgroups, respectively, mean changes in BCVA were +7.0 and +9.0 (8q12), +7.4 and +7.9 (8q16), and +8.0 and +9.4 (2q8) letters at Week 48; differences in least squares means were -0.30 and -0.64 letters between 8q12 and 2q8 and +0.17 and -1.76 letters between 8q16 and 2q8; ocular treatment-emergent adverse events were reported in 32.4% and 31.6% (8q12), 35.3% and 28.8% (8q16), and 30.0% and 27.2% (2q8) of patients.

Conclusion

Improvements in BCVA at Week 48 were generally similar with aflibercept 8 mg versus 2 mg in this subgroup analysis of Japanese and non-Japanese patients with DME, suggesting that the primary findings from PHOTON may be generalized to the Japanese population.