`Treatment in Patients With Neovascular Age-
`Related Macular Degeneration: 12-Month
`Results of the SUSTAIN Study
`
`
`
`Footnotes
`
`Abstract
`
`Samsung et al. v. Regeneron IPR2023-00884
`Regeneron Pharmaceuticals, Inc. Exhibit 2098 Page 1
`
`FREE
`ARVO Annual Meeting Abstract | April 2009
`F. G. Holz;
`C. Meyer; N. Eter; on behalf of the SUSTAIN study group
`Author A liations & Notes
`F. G. Holz
`Department of Ophthalmology, University of Bonn, Bonn, Germany
`C. Meyer
`Department of Ophthalmology, University of Bonn, Bonn, Germany
`N. Eter
`Department of Ophthalmology, University of Bonn, Bonn, Germany
`on behalf of the SUSTAIN study group
`Department of Ophthalmology, University of Bonn, Bonn, Germany
`Commercial Relationships F.G. Holz, Genentech, C; Acucela, C; P zer, C; Novartis, C; C. Meyer, Novartis, C;
`N. Eter, Novartis, C; Novartis, R.
`Support Novartis Pharma
`Investigative Ophthalmology & Visual Science April 2009, Vol.50, 3095. doi:
`Purpose: : To evaluate the safety and e cacy of individualized ranibizumab treatment over
`12 months of patients with neovascular age-related macular degeneration (AMD).
`Methods: : In the prospective, multi-center, single-arm SUSTAIN study of 12 months
`duration, 513 ranibizumab-naïve AMD patients (results reported below) and 18 AMD
`patients from the ANCHOR study received 3 initial monthly injections of ranibizumab (0.3
`mg) and re-treatment with ranibizumab (0.3/0.5 mg; one-third of patients switched to 0.5
`mg during the study) in the maintenance phase when they either lost >5 letters in best-
`corrected visual acuity (BCVA) compared with the highest prior BCVA score or their central
`
`
`Samsung et al. v. Regeneron IPR2023-00884
`Regeneron Pharmaceuticals, Inc. Exhibit 2098 Page 2
`
`retinal thickness (CRT) increased by >100 µm from the lowest prior value measured by
`optical coherence tomography (OCT). No re-treatment was given when CRT was <225 µm
`or BCVA ≥79 letters. BCVA and CRT were assessed monthly using Early Treatment for
`Diabetic Retinopathy Study charts and optical coherence tomography, respectively.
`Results: : On average, patients were treated 2.7 times from Months 3 to 11. 21% of
`patients received no re-treatment in the maintenance phase. Serious adverse events (AEs)
`in the study eye: retinal hemorrhage (n=2), cataract (n=1), retinal pigment epithelial tear
`(n=1), reduced visual acuity (n=1), vitreous hemorrhage (n=1). Most frequent non-ocular
`serious AEs: cardiac failure (n=6), myocardial infarction (n=5). Most frequent non-ocular
`AEs: nasopharyngitis (n=16), hypertension (n=15). Most frequent ocular AEs: reduced visual
`acuity (n=95), retinal hemorrhage (n=37), increased intraocular pressure (n=36). Mean
`change in BCVA from baseline to Months 3 and 12 was +5.8 and +3.6 letters, respectively.
`Mean change in CRT from baseline to Months 3 and 12 was -101.1 and -91.5 µm,
`respectively.
`Conclusions: : The incidence of AEs was comparable to previous pivotal clinical studies
`with ranibizumab. The e cacy results suggest that exible dosing based on VA/OCT-guided
`re-treatment criteria may stabilize but does not increase BCVA above the levels achieved in
`the loading phase. E cacy outcomes were achieved with a low average number of
`treatments.
`Clinical Trial: : www.clinicaltrials.gov NCT00331864
`Keywords: age-related macular degeneration • vascular endothelial growth factor • visual acuity
`© 2009, The Association for Research in Vision and Ophthalmology, Inc., all rights reserved.
`Permission to republish any abstract or part of an abstract in any form must be obtained in
`writing from the ARVO O ce prior to publication.
`
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