# Presentation: 316244

## Approved Products for the Treatment of CMV Retinitis in Immunocompromised Patients

- William M. Boyd, M.D.
- Division of Anti-inflammatory, Analgesic, and Ophthalmologic Drug Products
- HFD-550

## Approved Products

- Cytovene-IV (ganciclovir)
- Foscavir Injection (foscarnet)
- Cytovene Capsules (ganciclovir)
- Vitrasert Implant (ganciclovir)
- Vistide Injection (cidofovir)
- Vitravene for Injection (fomvirsen)

## Cytovene-IV (ganciclovir)

- Approved June 23, 1989
- Clinical Data Source(s) for Approval
- Study #1 - randomized, controlled trial, immediate versus delayed treatment (N = 42)
- Study #2 - nonrandomized, retrospective, immediate versus delayed treatment (N = 41)

## Cytovene-IV (ganciclovir)

- Primary Endpoints for Study #1 and #2:
- Time to progression of CMV retinitis
- Primary Endpoint Analysis
- Study #1 (photos): median time to progression of 50 days for immediate treatment; 14 days for delayed
- Study #2 (exam):  median time to progression of 71 days for immediate treatment; 29 days for delayed

## Foscavir Injection (foscarnet)

- Approved September 27, 1991
- Clinical Data Source(s) for Approval
- randomized, open label, controlled trial, immediate versus delayed treatment (N = 24)
- Primary Endpoint
- Time to progression of CMV retinitis

## Foscavir Injection (foscarnet)

- Primary Endpoint Analysis
- median time to progression of 93 days for immediate treatment; 22 days for delayed (photos)

## Cytovene Capsules (ganciclovir)

- Approved December 22, 1994
- Not approved for induction due to poor bioavailability (5% available)
- Study Design for Maintenance Indication
- three randomized, open label trials with Cytovene-IV as comparator (N total = 505)

## Vitrasert Implant (ganciclovir)

- Approved March 4, 1996
- Clinical Data Source(s) for Approval
- randomized, parallel, ganciclovir implant versus ganciclovir IV (N =188)
- Primary Endpoint
- Time to progression of CMV retinitis

## Vitrasert Implant (ganciclovir)

- Primary Endpoint Analysis
- median time to progression of 210 days for immediate treatment; 120 days for delayed (photos)

## Vistide Injection (cidofovir)

- Approved June 26, 1996
- Clinical Data Source(s) for Approval
- randomized, open label, controlled trial, immediate versus delayed treatment (N = 48)
- Primary Endpoint
- Time to progression of CMV retinitis

## Vistide Injection (cidofovir)

- Primary Endpoint Analysis
- median time to progression of 120 days for immediate treatment; 22 days for delayed (photos)

## Vitravene for Injection (fomvirsen)

- Approved August 26, 1998
- Clinical Data Source(s) for Approval
- limited, open label, controlled clinical studies, immediate versus delayed treatment
- 	(N = 80 eyes)
- Primary Endpoint
- Time to progression of CMV retinitis

## Vitravene for Injection (fomvirsen)

- Primary Endpoint Analysis
- median time to progression of 80 days for immediate treatment; 14 days for delayed (photos)

## Approved Products

## Approved Products for the Treatment of CMV Retinitis in Immunocompromised Patients

- William M. Boyd, M.D.
- Division of Anti-inflammatory, Analgesic, and Ophthalmologic Drug Products
- HFD-550

## Valcyt 450 mg Tablets (valganciclovir hydrochloride) NDA 21-304

## valganciclovir tablets

- NDA submitted September 28, 2000
- Clinical Data Source(s) for Approval
- randomized, open label, parallel group, valganciclovir versus ganciclovir IV (N=160)
- Primary Endpoint
- proportion of patients with disease progression at week 4

## valganciclovir tablets

- Primary Endpoint Analysis
- 7 subjects in valganciclovir arm and 7 subjects in the ganciclovir treatment arm had CMV progression at week 4 (photos)

## valganciclovir tabletsAnalysis of CMV Retinitis Progression by Week 4 Compared to Baseline(Medical Officer’s Masked Photographic Assessment)

## valganciclovir tablets

## valganciclovir tablets