EFFICACY and SAFETY of PHACODYNE™ for STAINING ANTERIOR CAPSULE DURING CATARACT SURGERY Joana Brandão Lencart, Phd, and Diogo Sousa Martins, Phd, MBA

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Rua das Ferrarias Del Rei, 6 • 2730-269 Barcarena – Oeiras, Portugal • tel: +351 21 044 30 13 • www.kemin.com EFFICACY AND SAFETY OF PHACODYNE™ FOR STAINING ANTERIOR CAPSULE DURING CATARACT SURGERY Joana Brandão Lencart, PhD, and Diogo Sousa Martins, PhD, MBA

This summary about the “Efficacy and safety of Phacodyne™ for staining anterior capsule during cataract surgery” is based on one article: x All surgeons considered Vianna LM, Cohen MJ, Muccioli C, Lima A, Sousa-Martins D, Maia M, Phacodyne effective and useful Belfort Jr R. Efficacy and safety of a lutein-based dye (Phacodyne™) for for AC staining visualizing anterior capsulorhexis during cataract surgery by phacoemulsification. Submitted to J Cataract Refract Surg.1 x There were no dye-related event ABSTRACT x Ocular examinations didn’t show The purpose of this study was to evaluate the efficacy and safety of a novel any dye-related toxicity lutein*-based dye to stain the anterior lens capsule (AC) during the x Phacodyne is safe and phacoemulsification technique in cataract surgery in humans. Twenty five efficacious in staining the eyes of 25 patients were operated by 25 different surgeons who performed anterior lens capsule during continuous circular capsulorhexis guided by a cataract surgery lutein-based dye (Phacodyne™) during cataract surgery by phacoemulsification. A questionnaire evaluated the surgeon’s opinion about the performance, efficacy, and usefulness of the dye. Follow-up examinations were performed at 1, 7 and 30 days postoperatively and subjects underwent extensive eye examinations to evaluate the safety of the dye. This new dye showed to be efficient when used for anterior capsulorhexis during cataract surgery by phacoemulsification and showed no signs of toxicity or side effects after 30 days follow-up. *Lutein possesses an isomer called zeaxanthin, which is also present in the formulation.

INTRODUCTION The continuous circular capsulorhexis (CCC) of the AC, is a critical step in the modern cataract surgery performed by phacoemulsification technique, offering advantages for the implantation of the intraocular lens correctly into the capsular bag. Good visualization of the anterior capsule flap is needed when performing the CCC especially in the absence of the red reflex.2 In ophthalmology, vital dyes have long been used as tools that enable surgeons to better visualize the transparent intraocular membranes and tissues, such as the AC.3 Staining the AC facilitates its identification and removal during cataract surgery by phacoemulsification.2 Lutein is a naturally occurring dye that has shown preclinical efficacy as an intraocular dye.4 This clinical investigation examined the efficacy and safety of a novel dye composed of lutein in combination with trypan blue (TB), to stain the AC during cataract surgery.

METHODS This study was a prospective, non-randomized, single-arm, clinical trial (Figure 1). Twenty five eyes of 25 patients were operated by 25 different surgeons who performed CCC guided by a lutein-based dye (Phacodyne™) during cataract surgery by phacoemulsification. Subjects underwent extensive eye examinations prior to surgery. The dye was applied to each subject for 30 seconds during surgery, and was removed at the end of surgery. A questionnaire evaluated the surgeon’s opinion about the performance, efficacy, and usefulness of the dye. Follow-up examinations were performed at 1, 7 and 30 days postoperatively and subjects underwent extensive eye examinations to evaluate the safety of the dyes. Safety was evaluated using different ophthalmic test methods: best corrected visual acuity, applanation tonometry, biomicroscopy, indirect ophthalmoscopy, optical coherence tomography, pachymetry, and specular microscopy.

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Figure 1 – Study design.

RESULTS Intraoperative findings. The lutein-based dye resulted in a final green solution that stained the AC and facilitated the CCC procedure (Figure 2). The phacoemulsification followed by intraocular lens implantation was performed as traditionally reported by cataract surgeons. No sutures were necessary.

Figure 2 - Anterior capsule staining with the solution containing 1% soluble lutein and 0.04% TB, facilitating the CCC procedure.

Questionnaires. The questionnaires showed that surgeons considered that Phacodyne™ stained the AC and facilitated the CCC procedure in all eyes (Tables 1 and 2). According to the surgeons, during the study, no dye-related adverse events were observed (Table 3).

Table 1. How was the visualization of the anterior lens capsule after application of the dye? Answer Number of surgeons Percentage Good 25 100.0% Poor 0 0.0%

Table 2. Was the dye useful and suitable for staining the anterior lens capsule? Answer Number of surgeons Percentage Yes 25 100.0% No 0 0.0%

Table 3. Notification of device-related adverse events during the course of the study Answer Number of surgeons Percentage Yes 0 0.0% No 25 100.0%

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Physical Evaluation and Ocular Examinations at Baseline and Follow-up. Average visual acuity improved significantly (p<0.0001) from baseline (0.89 ±0.59) to the 30-day follow-up visit post-surgery (0.23 ±0.22). Average intraocular pressure decreased significantly from baseline and 30-day follow-up visit post-surgery (p<0.05). There were no significant changes in pachymetry. Examination of the patients by biomicroscopy, ophthalmoscopy, and specular microscopy didn’t show any dye-related side effects.

DISCUSSION New dyes with a better safety profile than synthetic dyes are important for optimizing the outcome of modern ophthalmic surgery,4,5 and natural dyes such as lutein offer a potentially safer and more efficacious method of identifying intraocular structures such as AC. Results from this study show that Phacodyne is effective when used for anterior capsulorhexis during cataract surgery by phacoemulsification and showed no signs of toxicity or side effects up until 30 days follow-up. Surgeons found Phacodyne to be a useful dye for assisting with cataract surgery.

References 1. Vianna LM, Cohen MJ, Muccioli C, Lima A, Sousa-Martins D, Maia M, Belfort Jr R. 2013. Efficacy and safety of a lutein-based dye (Phacodyne™) for visualizing anterior capsulorrhexis during cataract surgery by phacoemulsification. Submitted to J Cataract Refract Surg. 2. Jacobs DS, Cox TA, Wagoner MD et al. 2006. Capsule staining as an adjunct to cataract surgery: a report from the American Academy of Ophthalmology. Ophthalmology. 113(4):707-13. 3. Rodrigues EB, Penha FM, et al. 2008. Historical aspects and evolution of the application of vital dyes in vitreoretinal surgery and chromovitrectomy. Dev Ophthalmol. 42:29–34. 4. Sousa-Martins D, Maia M, Moraes M, Lima-Filho AAS, Rodrigues EB, Chen J, Farah ME, Santos LB, Belfort Jr R. 2012. Use Of Lutein And Zeaxanthin Alone Or Combined With Brilliant Blue To Identify Intraocular Structures Intraoperatively. Retina;32(7):1328-36. SA-12-02814.

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