Valeda^™ PBM

Valeda Important Product Information

Indications for Use

The Valeda Light Delivery System is intended to provide improved visual acuity in patients with best-corrected visual acuity of 20/32 through 20/70 and who have dry age-related macular degeneration (AMD) characterized by:

• The presence of at least 3 medium drusen (> 63 μm and = 125 μm in diameter), or large drusen (> 125 μm in diameter), or non-central geographic atrophy, AND
• The absence of neovascular maculopathy or central-involving geographic atrophy. After about two years, the Valeda Light Delivery System treatment provides improved mean visual acuity of approximately one line of visual acuity (ETDRS) compared to those not receiving the treatment.

Contraindications for Use

As a precaution, patients have not been tested and should not be treated with Valeda if they have any known photosensitivity to yellow light, red light, or near-infrared radiation (NIR), or if they have a history of light-activated central nervous system disorders (e.g., epilepsy, migraine). In addition, patients should not receive treatment within 30 days of using photosensitizing agents (e.g., topicals, injectables) that are affected by 590, 660, and/or 850 nm light before consulting with their physician.

Precautions

Safety and effectiveness in patient populations and/or conditions excluded from the clinical study has not been established. This includes the following: patients under the age of 50, pregnant or nursing women, current or history of neovascular maculopathy, presence of center involving geographic atrophy (GA) within the central 1mm diameter, media opacities, including cataracts, which might interfere with visual acuity or imaging in the eye, posterior capsule opacification, which might interfere with visual acuity or imaging in the eye, ocular disorder or disease that partially or completely obstructs the pupil, any visually significant disease in any ocular structure apart from dry AMD.

An analysis of the primary effectiveness endpoint (mean BCVA change from baseline for the PBM arm – the mean BCVA change in the Sham arm) showed the following differences between arms for the subgroup of pivotal study patients with early AMD (Beckman Clinical Category Classification):

- At Month 13: +1.90 letters

- At Month 21: -0.10 letters

- At Month 24: +0.29 letters

The eyecare practitioner should consider the observed benefit/risk profile for this sub-population, when contemplating treatment of patients with this classification of Early AMD.

It is possible that treatment benefit may not persist significantly after treatment is stopped. The clinical study provided no significant data concerning the safety and effectiveness of the device should treatments be applied more frequently than described in this manual, or if more than 54 total treatments are delivered per eye.

Twelve (12) eyes (12.9%) in the PBM group and 4 eyes (7.3%) in the Sham group had a fellow eye that had neovascular AMD (nAMD). Of these 5 (41.7%) of 12 eyes in the PBM-treated group converted to nAMD, and 1 (25.0%) of the 4 eyes in the Sham group converted to nAMD. The eye care practitioner should consider the benefit/risk profile in this sub-population and should closely monitor patients whose fellow eye has nAMD.